FrancophonIA/ELRC3.0 huggingface dataset:
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 (is-Cmax intermedju u l-AUC 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: The diameter of the film-coated tablet is
Maltese: Kontenut tal-pillola
English: DFSP (at dose 800 mg)
Maltese: D (doża tal-bidu 400 mg)
English: Teva Nederland B.V. Tel: +31 800 0228 400
Maltese: Deutschland TEVA GmbH Tel: +49 731 402 08
English: This clinical effect was associated with a higher reduction in bcr-abl 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: Papilloma/carcinoma of the preputial/clitoral gland were noted from 30 mg/kg/day onwards, representing approximately 0.5 or 0.3 times the human daily exposure (based on AUC) at 400 mg/day or 800 mg/day, respectively, and 0.4 times the daily exposure in children (based on AUC) at 340 mg/m2/day.
Maltese: 0.5 jew 0.3-il darba ta' l-esponiment ta' kuljum fil-bniedem (bażat fuq l-AUC) b'400 mg/jum jew 800 mg/jum, rispettivament, u 0.4-il darba l-esponiment fit-tfal (bażat fuq l-AUC) b'340 mg/m2/jum.
English: Posology for DFSP The recommended dose of Imatinib Teva B.V. is 800 mg/day for adult patients with DFSP.
Maltese: Pożoloġija għal DFSP Id-doża rakkomandata ta' imatinib għal pazjenti adulti b'DFSP hija ta' 800 mg/jum.
English: 4 Flushing was most common in GIST patients and bleeding (haematoma, haemorrhage) was most common in patients with GIST and with transformed CML (CML-AP and CML-BC).
Maltese: Fwawar kienu l-aktar komuni f'pazjenti b'GIST u fsada (ematoma, emorraġija) kienet l-aktar komuni f'pazjenti b'GIST u b'CML trasformat (CML-AP u CML-BC).
English: DEX 40 mg/day on days 1-4 and 11-14, alternated with MTX 1 g/m2 i.v.
Maltese: DEX 40 mg/jum on jum 1-4 u 11-14, alternat ma' MTX 1 g/m2 i.v. (24 siegħa), jum 1, Ara-C 1 g/m2 i.v. (2 siegħa, q 12-il siegħa), jum 2-3
English: Seventeen (17) patients with GIST (with or without Kit and PDGFR mutations) were reported in 7 publications.
Maltese: Kienu rrappurtati 17-il pazjent b'GIST (b'Kit u mutazzjonijiet PDGFR jew mingħajrhom) f'7 pubblikazzjonijiet.
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: metoprolol b'madwar 23% (90%CI [1.16-1.30]).
English: Figure 2 Kaplan-Meier estimates for overall survival (ITT population)
Maltese: 2 L-istimi Kaplan-Meier għas-sopravivenza sħiħa (popolazzjoni ITT)
English: G-CSF (5 μg/kg, SC): days 5-14 or until ANC > 1500 post nadir Triple IT therapy (age-adjusted): days 1 and 15
Maltese: G-CSF (5 μg/kg, SC): jiem 4-13 jew sa ANC > 1500 postnadir
English: 1200 to 1600 mg (duration varying between 1 to 10 days): Nausea, vomiting, diarrhoea, rash, erythema, oedema, swelling, fatigue, muscle spasms, thrombocytopenia, pancytopenia, abdominal pain, headache,
Maltese: Popolazzjoni adulta 1200 sa 1600 mg (tul ta' żmien ivarja minn jum 1 sa 10 ijiem): Nawsja, rimettar, dijarea, raxx, eritema,
English: Methotrexate (5 g/m2 over 24 hours, IV): day 1
Maltese: Methotrexate (5 g/m2 fuq medda ta' 24 siegħa, IV): jum 1
English: Imatinib Teva B.V. 400 mg hard capsules are available in pack sizes of 30x1 or 90x1 hard capsules in perforated unit dose blisters.
Maltese: Imatinib Teva B.V. 400 mg kapsuli iebsin huma disponibbli f'pakketti ta' daqs ta' 30x1 jew 90x1 kapsuli iebsin f'folji ta' doża waħda perforati.
English: Iron oxide, red (E172) Printing ink Shellac
Maltese: Iron oxide black (E172) Propylene glycol
English: Reinduction block 2 VCR (1.5 mg/m2/day, IV): days 1, 8 and 15
Maltese: VCR (1.5 mg/m2/kuljum, IV): jiem 1, 8 u 15
English: The recommended dose of Imatinib Teva B.V. is 600 mg/day for adult patients in blast crisis.
Maltese: Id-doża ta' imatinib rakkomandata hija ta' 600 mg/jum f' pazjenti adulti f' blast crisis.
English: 6-MP (75 mg/m2/day, PO): days 11-56 (Withhold 6-MP during the 6-10 days of cranial irradiation beginning on day 1 of Cycle 5.
Maltese: DEX (6 mg/m2/kuljum, PO): jiem 1-5; 29-33 6-MP (75 mg/m2/kuljum, PO): jiem 11-56 (Miżmuma 6-MP matul is-6-10 ijiem ta' irrdjazzjoni kranjali mibdija fl-1 ġurnata ta' Ċiklu 5.
English: Imatinib Teva B.V. 400 mg film-coated tablets Pack sizes of 30 or 90 film-coated tablets in blisters.
Maltese: Imatinib Teva B.V. 400 mg pilloli miksija b' rita Pakketti li fihom 30 jew 90 pilloli miksija b'rita f' folji.
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, non-randomised 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: The median duration of the neutropenic and thrombocytopenic episodes usually ranged from 2 to 3 weeks, and from 3 to 4 weeks, respectively.
Maltese: newtropinja u tromboċitopenja damu medja ta' bejn 2-3 ġimgħat u minn 3 sa 4 ġimgħat, rispettivament.
English: Store below 30°C
Maltese: Taħżinx f'temperatura 'l fuq minn 30°C.
English: The same publication reported long term follow-up data from 12 MDS/MPD patients with PDGFR gene rearrangements (5 patients from study B2225).
Maltese: L-istess publikazzjoni rappurtat dejta fuq żmien twil ta' follow-up minn 12 pazjenti b'MDS/MPD b'tibdil fil-ġene PDGFR (5 pazjenti minn studju B2225).
English: The results of subgroup analyses according to the United States National Institutes of Health (NIH) and the Armed Forces Institute of Pathology (AFIP) risk classifications are shown in Table 6.
Maltese: Ir-riżultati tal-analiżi tas-sottogrupp skond il-klassifikazzjonijiet tar-riskju tal-Istituti Nazzjonali tas-Saħħa ta' l-Istati Uniti (NIH) u tal-Istitut tal-Patoloġija tal-Forzi Armati (AFIP) tal-Istati Uniti huma murija f'Tabella 6.
English: Liver function (transaminases, bilirubin, alkaline phosphatase) should be monitored regularly in patients
Maltese: Il-funzjoni tal-fwied (transaminases, bilirubin, alkaline phosphatase) għandha tiġi immonitorjata b'mod regolari f'pazjenti li jkunu qed jirċievu imatinib.
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: Paediatric patients: 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-il pazjent pedjatriku ta' età ta' < 18-il sena li jew kellhom CML fil-fażi lkronika (n=11) jew kellhom CML fi blast crisis jew lewkimji akuti (n=15) b'Ph+ kienu reklutati fi prova ta'
English: Imatinib Teva is also a treatment for adults and children for: - Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL).
Maltese: Lewkimja limfoblastika akuta posittiva għall-kromosoma ta' Filadelfja (Ph-posittiva ALL).
English: Imatinib Teva B.V. 400 mg film-coated tablets
Maltese: Imatinib Teva B.V. 400 mg pilloli miksija b'rita
English: Bilirubin
Maltese: Parzjali
English: In addition, thirty-six (36) months of imatinib treatment significantly prolonged overall survival (OS) compared to 12 months of imatinib treatment (HR = 0.45 [0.22, 0.89], p=0.0187) (Table 7, Figure 2).
Maltese: Barra minn hekk, sitta u tletin (36) xahar ta' trattament bi Glivec tawwal b'mod qawwi s-sopravivenza sħiħa (OS) mqabbel mat-12-il xahar ta' trattament bi Glivec (HR = 0.45 [0.22, 0.89], p=0.0187) (Tabella 7, Figura
English: The recommended dose of Imatinib Teva B.V. is 400 mg/day for adult patients with MDS/MPD.
Maltese: Pożoloġija għal MDS/MPD Id-doża ta' Imatinib Teva B.V. rakkomandata għal pazjenti adulti b'MDS/MPD hija 400 mg/jum.
English: The renal adenoma/carcinoma, the urinary bladder and urethra papilloma, the small intestine adenocarcinomas, the parathyroid glands adenomas, the benign and malignant medullary tumours of the adrenal glands and the non-glandular stomach papillomas/carcinomas were noted at 60 mg/kg/day, representing approximately 1.7 or 1 times the human daily exposure (based on AUC) at 400 mg/day or 800 mg/day, respectively, and 1.2 times the daily exposure in children (based on AUC) at 340 mg/m2/day.
Maltese: L-adenoma/karċinoma tal-kliewi, il-bużżieqa ta' lawrina u papilloma ta' l-uretra, l-adenokarċinomi ta' l-imsaren, l-adenomi tal-glandoli paratajrojd, it-tumuri benini u malinni tal-mudullun tal-glandoli adrenali u tal-papillomi/karċinomi ta' l-istonku mingħajr ilglandoli dehru b'60 mg/kg/jum, li jiġu madwar 1.7-il darba jew darba 1 l-esponiment ta' kuljum fil-bniedem (bażat fuq l-AUC) b'400 mg/jum jew 800 mg/jum, rispettivament, u 1.2-il darba l-esponiment ta' kuljum fittfal (bażat fuq l-AUC) b'340 mg/m2/jum.
English: Insomnia
Maltese: Ipotirojdiżmu
English: Ara-C: cytosine arabinoside; CP: cyclophosphamide; DEX: dexamethasone; MTX: methotrexate; 6MP: 6-mercaptopurine VM26: Teniposide; VCR: vincristine; IDA: idarubicine; i.v.
Maltese: VM26: Teniposide; VCR: vincristine;
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- prodott mediċinali li kien rappurtat (≥ 10%) kienu tqallih ħafif, rimettar, dijarrea, uġigħ addominali, għejja, majalġja, bugħawwieġ u raxx.
English: Pack sizes of 60 or 120, hard capsules in blisters.
Maltese: Pakketti li fihom 60 jew 120 kapsuli iebsin f' folji.
English: Vincristine 2 mg i.v., days 4, 11; Doxorubicine 50 mg/m2 i.v.
Maltese: Vincristine 2 mg i.v., jum 4, 11;
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 ta' sokkors b'imatinib ingħatat f'pazjenti li ma urewx rispons jew li urew rispons fqir għall-kimoterapija, irriżulta li 9 pazjenti (81.8%) minn 11 kisbu rispons ematoloġiku komplet.
English: Croatia
Maltese: Hrvatska
English: Study AUS01 Induction-consolidation therapy Hyper-CVAD regimen: CP 300 mg/m2 i.v.
Maltese: 4-il darba l-esponiment fit-tfal (bażat fuq l-AUC) b'340 mg/m2/jum.
English: If cytopenia is unrelated to leukaemia, reduce dose of imatinib to 260 mg/m2.
Maltese: Jekk iċ-ċitopenja ma tkunx relatata mallewkimja, naqqas id-doża ta' imatinib għal 260 mg/m2.
English: Imatinib Teva B.V. is indicated for
Maltese: Imatinib Teva B.V..
English: Active substances that may decrease imatinib plasma concentrations:
Maltese: Sustanzi attivi li jistgħu jnaqqsu l-konċentrazzjonijiet ta' imatinib fil-plażma:
English: Thrombocythaemia, lymphopenia, bone marrow depression, eosinophilia, lymphadenopathy
Maltese: Newtropenja, tromboċitopenja, anemija Panċitopenja, newtropenija bid-deni
English: doses)iii: days 2, 3, 16, and 17
Maltese: q6h x 6 dożi)iii: Jiem 2, 3, 16, u 17 Terapija IT tripla (aġġustata skont l-età): jiem 1 u 22
English: 6.6 Special precautions for disposal
Maltese: 6.1 Lista ta' eċċipjenti
English: Flatulence, abdominal distension, gastro-oesophageal reflux, constipation, dry mouth, gastritis
Maltese: infezzjoni tal-passaġġ tal-awrina, gastro-enteretite, sepsi
English: Imatinib was administered intermittently in cohorts 1-5, with increasing duration and earlier start of imatinib from cohort to cohort; cohort 1 receiving the lowest intensitiy and cohort 5 receiving the highest intensity of imatinib (longest duration in days with continuous daily imatinib dosing during the first chemotherapy treatment courses).
Maltese: Imatinib ingħata b'mod intermittenti b'koorti ta' 1-5, b'żieda fid-dewmien u bi tnedija bikrija ta' Imatinib minn koorti għal koorti; koorti 1 jingħata l-anqas intensità u koorti 5 jingħata logħla intensità ta' Imatinib (l-iktar dewmien fi ġranet b'doża ta' Imatinib kuljum b'mod kontinwu matul lewwel korsijiet ta' trattament b'kemotarapija).
English: Colitis, ileus, inflammatory bowel disease
Maltese: pankrejatite Kolite, iljus, marda ta' l-infjammazzjoni ta' l-imsaren
English: MTX (5 g/m2 over 24 hours, IV): day 1 Leucovorin (75 mg/m2 at hour 36, IV; 15 mg/m2 IV or PO q6h x 6
Maltese: MTX (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 and 3
English: Imatinib Teva B.V. 100 mg film-coated tablets Pack sizes of 60 or 120 film-coated tablets in blisters.
Maltese: Imatinib Teva B.V. 100 mg pilloli miksija b'rita huma disponibbli f'pakketti ta '60 jew 120 pillola miksija b'rita f'folji.
English: Methotrexate (5 g/m2 over 24 hours, IV): days 1 and 15 Leucovorin (75 mg/m2 at hour 36, IV; 15 mg/m2 IV or PO q6h x 6
Maltese: Methotrexate (5 g/m2 fuq medda ta' 24 siegħa, IV): jiem 1 u 15 Leucovorin (75 mg/m2 fis-36 siegħa, IV; 15 mg/m2 IV jew PO
English: Daunorubicin 60 mg/m2 i.v.
Maltese: Prednisolone 60 mg/m2/jum orali
English: Start 6-MP the 1st day after cranial irradiation completion.)
Maltese: Ibda 6-MP fl-1el ġurnata wara t-tmiem tal irradjazzjoni kranjali.)
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 fil-pazjenti 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: Immune system disorders Not known:
Maltese: Disturbi fis-sistema immuni
English: • 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
Maltese: • Pazjenti pedjatriċi li jkunu għadhom kif ġew dijanjostikati b'lewkimja majelojd kronika (CML) li huma posittivi (Ph+) għall-kromosoma ta' Filadelfja (bcr-abl) u li ma jkunux jistgħu jirċievu trapjant tal-mudullun bħala l-kura preferita.
English: 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 GIST and DFSP and on recurrence-free survival in adjuvant GIST.
Maltese: Id-doża ta' 600 mg/jum imatinib, bħala monoterapija, hija sigura u effetiva u tista' tiġi mogħtija għal Ph+ ALL f'pazjenti adulti li rkadew jew f'fażi rifrattorja sakemm ikun hemm progressjoni tal-marda.
English: What Imatinib Teva B.V. looks like and contents of the pack
Maltese: Kif jidher Imatinib Teva B.V. u l-kontentut tal-pakkett
English: - Each film-coated tablet of Imatinib Teva B.V. contains 100 mg imatinib (as mesilate).
Maltese: Kull pillola miksija b'rita fiha 100 mg imatinib (as mesilate).
English: ULN = upper limit of normal for the institution
Maltese: ULN = il-limitu ta' fuq in-normal ta' l-instituzzjoni AST = aspartate aminotransferase
English: Hypokalaemia, increased appetite, hypophosphataemia, decreased appetite, dehydration, gout, hyperuricaemia, hypercalcaemia,
Maltese: cyclosporine, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine,
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: Wieħed għandu joqgħod attent meta imatinib jittieħed ma' inibituri tal-protease, sustanzi kontra l-moffa azole, ċerti makrolidi (ara sezzjoni 4.5), sottostrati ta' CYP3A4 b'tieqa terapewtika dejqa (eż.
English: Carriers of HBV who require treatment with Imatinib Teva B.V. 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 Teva B.V. għandhom jiġu mmonitorjati mill-qrib għal sinjali u għal sintomi tal-infezzjoni attiva tal-HBV waqt il-kura u għal diversi xhur wara li tintemm il-kura (ara sezzjoni 4.8).
English: Anaphylactic shock* Blood and lymphatic system disorders
Maltese: Trombożi/emboliżmu* Disturbi respiratorji, toraċiċi u medjastinali
English: - Keep this leaflet.
Maltese: Retenzjoni ta' fluwidi
English: Dosing in children at 260 and 340 mg/m2/day achieved the same exposure, respectively, as doses of 400 mg and 600 mg in adult patients.
Maltese: II. Dożi ta' 260 u 340 mg/m2/jum kisbu l-istess esponiment, rispettivament, bħalma jkun hemm fladulti b'dożi ta' 400 mg u 600 mg.
English: Imatinib Teva B.V. 400 mg hard capsules are available in pack sizes of 30 or 90 hard capsules in blisters.
Maltese: Imatinib Teva B.V. 400 mg kapsuli iebsin huma disponibbli f'pakketti ta '30 jew 90 kapsuli iebsin f'folji.
English: 31.6%, respectively).
Maltese: (medda 16-59), rispettivament.
English: NAME OF THE MEDICINAL PRODUCT Imatinib Teva B.V. 100 mg film-coated tablets Imatinib Teva B.V. 400 mg film-coated tablets
Maltese: Imatinib Teva B.V. 100 mg pilloli miksijin b'rita Imatinib
English: Imatinib Teva B.V. 100 mg film-coated tablets are available in pack sizes of 20x1, 60x1, 120x1 or 180x1 film-coated tablets in perforated unit dose blisters.
Maltese: Imatinib Teva B.V. Pilloli miksija b'rita ta '100 mg huma disponibbli f'pakketti ta' daqs ta '20x1, 60x1, 120x1
English: ANC ≥ 1 x 109/l and platelets ≥ 20 x 109/l,
Maltese: x 109/L u plejtlets ≥ 75 x 109/L.
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: Jekk id-doża tiegħek ta' kuljum hija 800 mg (8 kapsuli), għandek tieħu 4 kapsuli filgħodu u 4 kapsuli filgħaxija.
English: Clinical cases of hypothyroidism have been reported in thyroidectomy patients undergoing levothyroxine replacement during treatment with imatinib (see section 4.5).
Maltese: 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: (24 h), days 1, 15; 6-MP 25 mg/m2 oral, days 1-20
Maltese: MTX 500 mg/m2 i.v. (24 siegħa), jum 1, 15; 6-MP 25 mg/m2 orali, jum 1-20
English: Clinical studies in adjuvant GIST
Maltese: Studji kliniċi b'GIST awżiljari
English: There is limited experience in children with Ph-positive ALL and very limited experience in children with MDS/MPD, DFSP, GIST and HES/CEL.
Maltese: Hemm esperjenza limitata dwar l-użu fit-tfal u adoloxxenti b'Ph+ ALL u esperjenza limitata ħafna dwar l-użu fittfal u adoloxxenti b'MDS/MPD, DFSP, u HES/CEL.
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-mediċina għal 70 jum qabel ma tgħammru, irriżulta li kien hemm tnaqqis fil-piż tat-testikoli u ta' l-epididimu u anke tnaqqis fil-perċentwal 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: Imatinib Teva B.V. 100 mg film-coated tablets
Maltese: Imatinib Teva B.V. 100 mg pilloli miksija b' rita
English: Triple IT therapy (age-adjusted): days 1 and 22 VP-16 (100 mg/m2/day, IV): days 22-26
Maltese: Terapija IT tripla (aġġustata skont l-età): jum 1 ARA-C (3 g/m2/doża q 12 h x 4, IV): jiem 2 u 3
English: NAME OF THE MEDICINAL PRODUCT Imatinib Teva B.V. 100 mg hard capsules Imatinib Teva B.V. 400 mg hard capsules
Maltese: Imatinib Teva B.V. 400 mg kapsuli miksija b' rita Imatinib
English: 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 għallfetu 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 mal-għajnejn u l-ġilda jew tħejid man-nifs (ara sezzjoni 4.6).
English: This was not seen at doses ≤ 20 mg/kg.
Maltese: Dan ma rriżultax meta ddożi li ntużaw kienu ta' ≤ 20 mg/kg.
English: Therefore, caution is recommended when administering imatinib with CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporine, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel and quinidine).
Maltese: fentanyl, alfentanil, terfenadine, bortezomib, docetaxel u quinidine).
English: • The treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST).
Maltese: • Il-kura ta' pazjenti adulti li jkollhom tumuri li jkunu pożittivi għal Kit (CD 117) u li ma jkunux jistgħu jitneħħew b'operazzjoni u/jew tumuri malinni u metastatiċi fl-istroma tas-sistema gastro-intestinali
English: Hypokalaemia, increased appetite, hypophosphataemia, decreased appetite, dehydration, gout, hyperuricaemia, hypercalcaemia, hyperglycaemia, hyponatraemia
Maltese: gotta, iperuriċemija, iperkalċimija, ipergliċimija, iponatrimija Iperkalimija, ipomagneżimja
English: Adult population
Maltese: Użu fl-adulti
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: Meta imatinib intuża waħdu f'pazjenti b' Ph+ ALL li jirkadi/rifrattorju, 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: Concomitant use of rifampicin or other strong CYP3A4 inducers and imatinib should be avoided.
Maltese: Sottostrati ta' CYP3A4 b'tieqa terapewtika dejqa (eż.
English: Therefore, concomitant use of strong CYP3A4 inducers and imatinib should be avoided (see section 4.5).
Maltese: eliminazzjoni minuri għal imatinib (ara sezzjonijiet 4.2 u 4.4).
English: GI tumour sites may have been the source of the GI bleeds (see section 4.4).
Maltese: GI jista' jkun il-kawża tal-fsada (ara sezzjoni 4.4).
English: : intravenous
Maltese: Investigazzjonijiet
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: (EIAEDs) bħal carbamazepine, oxcarbazepine u phenytoin.