FrancophonIA/ELRC3.0 huggingface dataset:
English: Risedronaatnatrium Mylan Wekelijks 35 mg filmcoated tablets Oral use
Maltese: Risedronaatnatrium Mylan Wekelijks 35 mg
English: Ácido Alendrónico J. Neves 70 mg
Maltese: Ácido Alendrónico ITF 70 mg
English: Risedronate Teva 35 mg filmomhulde tabletten film-coated tablets
Maltese: Risedronate Teva 35 mg filmomhulde tabletten
English: QUIMICA FARMACEUTICA BAYER, S.L.Av.
Maltese: BAYER, S.L.Av.
English: PAMIDRONATE DE SODIUM HOSPIRA 3 mg/ml, solution à diluer pour perfusion
Maltese: HOSPIRA 3 mg/ml, solution à diluer pour perfusion
English: Actonel enkrat tedensko 35 mg filmsko obložene tablete film-coated tablet Oral use
Maltese: Actonel enkrat tedensko 35 mg filmsko obložene tablete
English: ACTONEL 5 mg, comprimé pelliculé film-coated tablet Oral use
Maltese: ACTONEL 5 mg, comprimé pelliculé
English: ACTONEL 35 mg, comprimé pelliculé film-coated tablet Oral use
Maltese: ACTONEL 35 mg, comprimé pelliculé
English: 1045 Budapest Hungary
Maltese: 1036 Budapest
English: 9 mg/ml concentrate for solution for infusion - 10 ml
Maltese: 9 mg/ml konċentrat għall-soluzzjoni għall-infużjoni - 10 ml
English: Ref. EMEA/477488/2008
Maltese: EMEA/548383/2008
English: International non-proprietary name (INN): dalbavacin
Maltese: Denominazzjoni Komuni Internazzjonali (DKI): dalbavacin
English: It contains the active substance dalbavancin.
Maltese: Is-sustanza attiva fih hija dalbavancin.
English: What is EXULETT?
Maltese: X'inhu EXULETT?
English: These bacteria include Staphylococcus aureus (including ‘methicillin-resistant' forms known as ‘MRSA') and Streptococcus pyogenes.
Maltese: Dawn ilbatterji jinkludu Staphylococcus aureus (inklużi forom ‘methicillin-reżistenti' magħrufa bħala ‘MRSA') u Streptococcus pyogenes.
English: The active substance in EXULETT, dalbavancin, is an antibiotic that belongs to the group ‘glycopeptides'.
Maltese: Is-sustanza attiva f'EXULET, dalbavancin, huwa antibijotiku li jappartjeni għall-grupp tal‘glikopeptidi'.
English: The company presented the results of one main study that compared the effects of EXULETT with those of linezolid (another antibiotic) in 873 adults.
Maltese: Il-kumpanija ppreżentat ir-riżultati ta' l-istudju prinċipali li qabbel l-effetti ta' EXULETT ma' dawk ta' linezolid (antibijotiku ieħor) f'873 adult.
English: On 9 September 2008, Pfizer Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for EXULETT, for the treatment of complicated skin and soft tissue infections in adults when known or suspected to be caused by susceptible Gram-positive bacteria.
Maltese: Fid-9 ta' Settembru 2008, Pfizer Limited innotifikat uffiċjalment lil Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirita l-applikazzjoni tagħha għal awtorizzazzjoni ta' tqegħid fis-suq ta' EXULETT, għat-trattament ta' infezzjonijiet kkumplikati tal-ġilda u tat-tessuti rotob f'adulti meta jkun magħruf jew suspettat li ġew ikkawżati mill-batterji suxxettibbli Grampożittivi.
English: What was EXULETT expected to be used for?
Maltese: Kif kien mistenni li jaħdem EXULETT?
English: The effects of EXULETT were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' EXULETT ġew l-ewwel ittestjati f'mudelli sperimentali qabel ma ġew studjati fuq ilbnedmin.
English: Based on the review of the data and the company's response to the CHMP list of questions at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that EXULETT could not have been approved for the treatment of complicated skin and soft tissue infections in adults when known or suspected to be caused by susceptible Gram-positive bacteria.
Maltese: Skond l-analiżi tad-dejta u t-tweġiba tal-kumpanija għal-lista ta' mistoqsijiet tas-CHMP, fi żmien lirtirar, is-CHMP kellu xi tħassib u kellu opinjoni proviżorja li EXULETT ma setax jiġi appruvat għattrattament ta' infezzjonijiet ikkumplikati tal-ġilda u tessut artab f'adulti meta jkun magħruf jew suspettat li ġew ikkawwżati mill-batterja suxxettibbli Gram-positive.
English: There were also concerns over whether EXULETT could be manufactured with consistent good quality.
Maltese: Kien hemm tħassib ukoll dwar jekk EXULETT jistax jiġi manifatturat bi kwalità konsistenti u tajba.
English: EXULETT is a powder that is made up into a solution for infusion (drip into a vein).
Maltese: EXULETT huwa trab li jsir soluzzjoni għall-infużjoni (dripp fil-vina).
English: How is EXULETT expected to work?
Maltese: Għal xiex kien mistenni li jintuża EXULETT?
English: EXULETT was to be used only when the infection was known or thought to be caused by types of bacteria that are classified as ‘Gram-positive' and that would be killed by the medicine.
Maltese: EXULETT kellu jintuża biss meta l-infezzjoni kienet magħrufa jew maħsuba li ġiet ikkawżata minn tipi ta' batterji li huma kklassifikati bħala ‘Gram-pożittivi' u li jistgħu jinqatlu mill-mediċina.
English: Molecular response**
Maltese: Rispons molekulari**
English: Polyvinyl alcohol partially hydrolysed Macrogol
Maltese: Polyvinyl alcohol parzjalment idrolizzat Macrogol
English: PVC/PE/PVdC/PE/PVC//Al blisters OPA/Al/PVC//Al blisters
Maltese: Folji tal- PVC/PE/PVdC/PE/PVC//Al Folji ta' OPA/Al/PVC//Al
English: [95% CI]
Maltese: [CI ta' 95%]
English: doses)iii:
Maltese: 6 dożi)iii:
English: Merckle GmbH Graf-Arco-Str. 3, 89079 Ulm Germany
Maltese: Merckle GmbH Graf-Arco-Str. 3, 89079 Ulm
English: Total bilirubin: > 3-10 ULN
Maltese: Bilirubin totali: > 3-10 ULN
English: Mogilska 80, 31-546 Krakow Poland
Maltese: Mogilska 80, 31-546 Krakow Il-Polonja
English: Store below 30°C.
Maltese: Aħżen f'temperatura taħt 30°C
English: % of patients (CI95%)
Maltese: % tal-pazjenti (CI95%)
English: Date of latest renewal: 18 September 2017
Maltese: Data tal-aħħar tiġdid: 18 ta' Settembru 2017
English: Study 0102 38-month data Myeloid blast crisis (n=260)
Maltese: Studju 0102 Dejta ta' 38 xahar Majelojd blast crisis (n=260)
English: Myeloid blast crisis
Maltese: Majelojd blast crisis
English: Danmark Teva Denmark A/S Tlf: +45 44985511
Maltese: Teva Denmark A/S Tlf: +45 44985511
English: doses)iii: days 2, 3, 16, and 17
Maltese: 6 dożi)iii: jiem 2, 3, 16, u 17
English: Teva Pharma B.V. Swensweg 5, 2031 GA Haarlem The Netherlands
Maltese: Teva Pharma B.V. Swensweg 5, 2031 GA Haarlem L-Olanda
English: C/C, n. 4, Poligono Industrial Malpica, 50016 Zaragoza Spain
Maltese: C/C, n. 4, Poligono Industrial Malpica, 50016 Zaragoza Spanja
English: Lymphoid blast crisis
Maltese: Limfojd blast crisis
English: Crospovidone Magnesium stearate Silica colloidal, anhydrous
Maltese: Crospovidone Magnesium stearate Silica colloidal, anidru
English: Mean absolute bioavailability for imatinib is 98%.
Maltese: Il-bijodisponibilità assoluta medja għal imatinib hija ta' 98%.
English: At 84 months the estimated overall survival is 86.4% (83, 90) vs. 83.3% (80, 87) in the randomised imatinib and the IFN+Ara-C groups, respectively (p=0.073, log-rank test).
Maltese: Fl-84 xahar is-sopravivenza globali hija stmata 86.4% (83, 90) vs 83.3% (80, 87) filgruppi randomised imatinib u IFN + Ara-C, rispettivament (p=0.073, test log-rank).
English: 10000 Zagreb Croatia
Maltese: Zagreb Kroazja
English: In vitro, imatinib inhibits paracetamol O-glucuronidation with Ki value of 58.5 micromol/l.
Maltese: In-vitro, imatinib jimpedixxi paracetamol O-glucuronidation b'valur Ki ta' 58.5 mikromol/l.
English: Deutschland AbZ-Pharma GmbH Tel: +49 73140205
Maltese: AbZ-Pharma GmbH Tel: +49 73140205
English: Daunorubicin 45 mg/m2 i.v., days 6-7, 13-14
Maltese: Daunorubicin 45 mg/m2 i.v., jiem 6-7, 13-14
English: DAUN (45 mg/m2/day bolus, IV): days 1 and 2
Maltese: DAUN (45 mg/m2/bolus kuljum, IV): jiem 1 u 2
English: MTX 15 mg intrathecal, day 1; Methylprednisolone 40 mg intrathecal, day 1
Maltese: MTX 15 mg intrathecal, jum 1; Methylprednisolone 40 mg intrathecal, jum 1
English: Return to chronic phase (RTC)
Maltese: Ritorn għall-fażi l-kronika (RTC)
English: Total bilirubin: > 1.5-3.0 ULN AST: any
Maltese: Bilirubin totali: > 1.5-3.0 ULN
English: Vascular disorders4 Common
Maltese: Disturbi vaskulari4
English: BCR-ABL tyrosine kinase inhibitors (TKIs) have been associated with thrombotic microangiopathy (TMA), including individual case reports for Imatinib Teva (see section 4.8).
Maltese: Inibituri ta' tyrosine kinase (TKIs - tyrosine kinase inhibitors) BCR-ABL ġew assoċjati ma' mikroanġjopatija trombotika (TMA - thrombotic microangiopathy), inklużi rapporti ta' każijiet individwali għal Imatinib Teva (ara sezzjoni 4.8).
English: Calcium hydrogen phosphate Crospovidone
Maltese: Il-qalba tal-pillola Calcium hydrogen phosphate Crospovidone
English: PLIVA Croatia Ltd. Prilaz baruna Filipovica 25 10000 Zagreb Croatia
Maltese: Prilaz baruna Filipovica 25 10000
English: The length of the capsule is from 23.0 mm to 23.6 mm and the width is 8.53 mm.
Maltese: It-tul tal-kapsula huwa minn 23.0 mm sa 23.6 mm b'wesgħa ta' 8.53 mm.
English: Prednisolone 60 mg/m2/day oral
Maltese: 21; Prednisolone 60 mg/m2/jum orali
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/808/001-020
Maltese: EU/1/12/808/001-020
English: VCR 1.3 g/m2 i.v., day 1; Prednisolone 60 mg/m2 oral, days 1-5
Maltese: VCR 1.3 g/m2 i.v., jum 1; Prednisolone 60 mg/m2 orali, jiem 1-5
English: 260 patients with myeloid blast crisis were enrolled.
Maltese: 260 pazjent b'majelojd blast crisis kienu reklutati.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/808/021-040
Maltese: EU/1/12/808/021-040
English: FIP1L1-PDGFRα fusion kinase was identified.
Maltese: F'61 minn dawn il-117 pazjent FIP1L1-PDGFRα fusion kinase kien identifikat.
English: Palmoplantar erythrodysesthesia syndrome*, lichenoid keratosis*, lichen planus*, toxic epidermal necrolysis*, drug rash with eosinophilia and systemic symptoms (DRESS)*, pseudoporphyria* Musculoskeletal and connective tissue disorders Very common
Maltese: Sindrome ta' eritrodisasteżija palmoplantari*, keratożi lichenoid*, lichen planus*, nekrolisi tossika tal-epidermide*, raxx ikkawżat mill-mediċina b'eosinofilja u sintomi sistemiċi (DRESS - drug rash with eosinophilia and systemic symptoms)*, psewdoporfirja*
English: 1800 mg to 3200 mg (as high as 3200 mg daily for 6 days): Weakness, myalgia, increased creatine phosphokinase, increased bilirubin, gastrointestinal pain.
Maltese: 1800 mg sa 3200 mg (sa doża għolja ta' 3200 mg kuljum għal 6 ijiem): Dgħufija, majalġja, żieda filcreatine phosphokinase, żieda fil-bilirubin, uġigħ gastrointestinali.
English: IT Methotrexate (age-adjusted): day 1 ONLY Triple IT therapy (age-adjusted): day 8, 15
Maltese: IT Methotrexate (aġġustata skont l-età): jum 1 BISS Terapija IT trippla (aġġustata skont l-età): jum 8, 15
English: A limited number of patients were enrolled in phase I studies (n=10).
Maltese: Numru limitat ta' pazjenti kienu reklutati fi studji ta' fażi I (n=10).
English: The tablets are approximately 9 mm in diameter.
Maltese: Il-pilloli huma bejn wieħed u ieħor 9 mm fid-dijametru.
English: Methotrexate (20 mg/m2/week, PO): days 8, 15, 22, 29, 36, 43, 50
Maltese: Methotrexate (20 mg/m2/ġimgħa, PO): jiem 1, 8, 15, 22, 29, 36, 43, 50
English: Study ADE10 Prephase
Maltese: Studju ADE10
English: HES/CEL (starting dose 100 mg)
Maltese: HES/CEL (b'doża ta' 400 mg)
English: Triple IT therapy (age-adjusted): days 1 and 22
Maltese: Terapija IT trippla (aġġustata skont l-età): jiem 1 u 22
English: • Adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement.
Maltese: • Pazjenti li jkollhom sindrome ipereżinofilika avvanzata (HES) u/jew lewkimja kronika eżinofolika (CEL) b'tibdil FIP1L1-PDGFR.
English: The translocation t(17:22)[(q22:q13)], or its gene product, was present in nearly all responders to imatinib treatment.
Maltese: It translokazzjoni t17:22)[(q22:q13)], jew il-prodott tal-ġene tiegħu, instab fil-pazjenti kollha li wrew rispons għall-kura b'imatinib.
English: Confusional state Nervous system disorders Very common
Maltese: Stat konfużjonali Disturbi fis-sistema nervuża Komuni ħafna
English: - Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL).
Maltese: - Lewkimja limfoblastika akuta posittiva għall-kromosoma ta' Filadelfja (Ph-posittiva
English: MTX 12 mg intrathecal, day 1
Maltese: MTX 12 mg intrathecal, jum 1
English: 6-MP (75 mg/m2/day, PO): days 8-28
Maltese: 6-MP (75 mg/m2/jum, PO): jiem 8-28
English: DEX 10 mg/m2 oral, days 1-5;
Maltese: DEX 10 mg/m2 orali, jiem 1-5;
English: Ki values in human liver microsomes were 27, 7.5 and 7.9 µmol/l, respectively.
Maltese: Il-valuri Ki fil-mikrosomi tal-fwied tal-bniedem kienu 27, 7.5 u 7.9 µmol/l, rispettivament.
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: issuperjorità ta' imatinib fuq IFN+Ara-C fis-sopravivenza globali kienet dimostrata (p< 0.001); fi żmien 42 xahar, 47 (8.5%) pazjenti fuq imatinib u 63 (19.4%) pazjenti fuq IFN+Ara-C kienu mietu.
English: Ara-C: cytosine arabinoside; CP: cyclophosphamide; DEX: dexamethasone; MTX: methotrexate; 6MP: 6-mercaptopurine VM26: Teniposide; VCR: vincristine; IDA: idarubicine; i.v.
Maltese: MTX: methotrexate; 6MP: 6-mercaptopurine VM26: Teniposide; VCR: vincristine;
English: FIP1L1-PDGFRα-positive in other 3 published reports.
Maltese: Erba' pazjenti oħra instabu posittivi għal FIP1L1-PDGFRα f'3 rapporti oħra li ġew publikati.
English: What Imatinib Teva contains - The active substance is imatinib (as mesilate).
Maltese: - Is-sustanza attiva hi imatinib (bħala mesilate).
English: Haematological and cytogenetic responses have been sustained for a median of 49 months (range 19-60) and 47 months (range 16-59), respectively.
Maltese: Risponsijiet ematoloġiċi u ċitoġenetiċi inżammu għall-medja ta' 49 xahar (medda bejn 19 u 60) u 47 xahar (medda 16-59), rispettivament.
English: 30 hard capsules 30x1 hard capsules 90 hard capsules 90x1 hard capsules
Maltese: 30 kapsula iebsa 30x1 kapsula iebsa 90 kapsula iebsa 90x1 kapsula iebsa
English: - Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL).
Maltese: - Sindrome ipereżinofilika (HES) u/jew Lewkimja eżinofilika kronika (CEL).
English: - The tablet coating is made of polyvinyl alcohol partially hydrolysed, macrogol, iron oxide yellow (E172), talc, titanium dioxide (E171) and iron oxide red (E172).
Maltese: - Il-kisja tal-pillola hi magħmula minn polyvinyl alkoħol parzjalment idrolizzat, macrogol, iron oxide isfar (E172) talc, titanium dioxide (E171) u iron oxide aħmar (E172).
English: A further 162 patients with HES/CEL, reported in 35 published case reports and case series received imatinib at doses from 75 mg to 800 mg daily.
Maltese: 162 pazjent ieħor b'HES/CEL, rappurtati f'35 rapporti ta' każijiet u serje ta' każijiet li ġew publikati irċevew imatinib b'dożi bejn 75 mg sa 800 mg kuljum.
English: DEX 10 mg/m2 oral, days 6-7, 13-16; VCR 1 mg i.v., days 7, 14;
Maltese: DEX 10 mg/m2 orali, jiem 6-7, 13-16; VCR 1 mg i.v., jiem 7, 14;
English: days 1-3;
Maltese: Ċikli 1-4
English: In adults the dose should be reduced from 400 mg to 300 mg or from 600 mg to 400 mg or from 800 mg to 600 mg, and in children from 340 to 260 mg/m2/day.
Maltese: Fl-adulti d-doża għandha titnaqqas minn 400mg ghal 300mg jew inkella minn 600 mg għal 400 mg, jew minn 800 mg għal 600 mg, u fit-tfal minn 340 għal 260 mg/m2/jum.
English: The complete molecular response rate was 48% (49 out of 102 evaluable patients).
Maltese: Ir-rata ta' rispons molekulari komplet kienet 48% (49 minn 102 pazjenti li setgħu jkunu evalwati).
English: MTX 15 mg intrathecal, day 1
Maltese: MTX 15 mg intrathecal, jum 1
English: CZ-74770 Opava - Komárov
Maltese: CZ-74770
English: Similar findings were found based on a 18-months landmark analysis.
Maltese: Sejbiet simili kienu evidenti minn analiżi landmark ta'18-il xahar.
English: Complete CyR n (%) Partial CyR n (%)
Maltese: n (%) ta' CyR sħiħ n (%) ta' CyR parzjali
English: ul.
Maltese: ULN
English: Imatinib and the N-demethyl metabolite together accounted for about 65% of the circulating radioactivity (AUC(0-48h)).
Maltese: Imatinib u l-metabolit N-demethyl flimkien kienu jgħoddu għal xi 65% tar-radjuattività fiċ-ċirkolazzjoni (AUC(0-48h)).
English: The length of the capsule is from 19.1 mm to 19.7 mm and the width is 6.91 mm. Imatinib Teva 400 mg hard capsules
Maltese: It-tul tal-kapsula huwa minn 19.1 mm sa 19.7 mm b'wesgħa ta' 6.91 mm.
English: In all clinical studies 38-40% of patients were ≥ 60 years of age and 10-12% of patients were ≥ 70 years of age.
Maltese: Fl-istudji kliniċi kollha 38-40% tal-pazjenti kellhom ≥ 60 sena u 10-12% tal-pazjenti kellhom ≥ 70 sena.
English: Clinical studies in chronic myeloid leukaemia
Maltese: - Lewkimja majelojd kronika (CML - Chronic myeloid leukaemia).
English: 20x1 hard capsules 60 hard capsules 60x1 hard capsules 120 hard capsules 120x1 hard capsules 180x1 hard capsules
Maltese: 20x1 kapsula iebsa 60 kapsula iebsa 60x1 kapsula iebsa 120 kapsula iebsa 120x1 kapsula iebsa 180x1 kapsula iebsa
English: Accelerated phase CML and blast crisis and Ph+ ALL (starting dose 600 mg)
Maltese: CML fil-fażi aċċelerata u blast crisis u Ph+ ALL (doża tal-bidu ta' 600 mg)
English: Cycle 5
Maltese: Ċiklu 5
English: Importantly, 27.7% of patients also achieved a major cytogenetic response, which was complete in 20.4% (confirmed 16%) of patients.
Maltese: Fatt importanti huwa li 27.7% tal-pazjenti kellhom ukoll reazzjoni ċitoġenetika maġġuri, li kienet kompleta fi 20.4% (ikkonfermata fi 16%) tal-pazjenti.
English: Improvements were reported in cardiac, nervous, skin/subcutaneous tissue, respiratory/thoracic/mediastinal, musculoskeletal/connective tissue/vascular, and gastrointestinal organ systems.
Maltese: Titjieb kienu rappurtati fis-sistemi kardijaċi, nervużi, ġilda/tessut ta' taħt il-ġilda, respiratorju/toraċiku/medjastinali/muskolu-skeletrali/ connective tissue/vaskulari, u gastro-intestinali.
English: The capsules are approximately 23 mm long and 9 mm wide.
Maltese: Il-kapsuli huma madwar 23 mm twal u 9 mm wiesgħa.
English: Vertigo, tinnitus, hearing loss
Maltese: Vertiġini, tinnitè, telf ta' smigħ
English: Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitor, ATC code: L01XE01
Maltese: Kategorija farmakoterapewtika: sustanza neoplastika, sustanza li tinpedixxi l-enzima protein kinase,
English: If laboratory or clinical findings associated with TMA occur in a patient receiving Imatinib Teva , treatment should be discontinued and thorough evaluation for TMA, including ADAMTS13 activity and antiADAMTS13-antibody determination, should be completed.
Maltese: Jekk is-sejbiet tal-laboratorju jew kliniċi assoċjati ma' TMA iseħħu f'pazjent li jkun qed jirċievi Imatinib Teva, it-trattament għandu jitwaqqaf u għandha titlesta evalwazzjoni bir-reqqa għal TMA, inkluża l-attività ta' ADAMTS13 u ddeterminazzjoni ta' antikorpi kontra ADAMTS13.
English: DFSP (at dose 800 mg)
Maltese: (doża ta' 800 mg)
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 impedixxa l-attivit tas-CYP2D6, isoenzima taċ-ċitokromju P450,
English: Imatinib is a small molecule protein-tyrosine kinase inhibitor that potently inhibits the activity of the Bcr-Abl tyrosine kinase (TK), as well as several receptor TKs: Kit, the receptor for stem cell factor (SCF) coded for by the c-Kit proto-oncogene, the discoidin domain receptors (DDR1 and DDR2), the colony stimulating factor receptor (CSF-1R) and the platelet-derived growth factor receptors alpha and beta (PDGFR-alpha and PDGFR-beta).
Maltese: (SCF) kkodifikat bis-c-Kit proto-oncogene, id-discoidin domain receptors (DDR1 u DDR2), il-colony stimulating factor receptor (CSF-1R) u l-platelet-derived growth factor receptors alpha u beta (PDGFR
English: One phase II, open label, multicentre clinical trial (study B2225) was conducted including 12 patients with DFSP treated with imatinib 800 mg daily.
Maltese: II, open label, f'ħafna ċentri (studju B2225) kien imwettaq b'12-il pazjent b'DFSP kurata b'imatinib 800 mg kuljum.
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: 6-MP (75 mg/m2/kuljum, PO): jiem 11-56 (Miżmuma 6-MP matul is6-10 ijiem ta' irradjazzjoni kranjali mibdija fl-ewwel jum ta' Ċiklu 5.
English: Posology for MDS/MPD The recommended dose of Imatinib Teva is 400 mg/day for adult patients with MDS/MPD.
Maltese: Pożoloġija għal MDS/MPD Id-doża ta' Imatinib Teva rakkomandata għal pazjenti adulti b'MDS/MPD hija 400 mg/jum.
English: The recommended dose of Imatinib Teva is 600 mg/day for adult patients with Ph+ ALL.
Maltese: Id-doża rakkomandata ta' Imatinib Teva hija 600 mg/jum għal pazjenti adulti b'Ph+ ALL.
English: The capsules are approximately 19 mm long and 7 mm wide.
Maltese: Il-kapsuli huma madwar 19 mm twal u 7 mm wiesgħa.
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 gie 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: Depending on your condition the usual starting dose is either 400 mg or 600 mg:
Maltese: Skont il-kondizzjoni tiegħek, id-doża li normalment tibda biha hija ta' 400 mg jew ta' 600 mg:
English: Imatinib was shown in vitro to be a competitive inhibitor of marker substrates for CYP2C9, CYP2D6 and CYP3A4/5.
Maltese: Ir-riżultati in vitro wrew li imatinib jimpedixxi b'mod kompetittiv lis-sustanzi markaturi li fuqhom jaħdmu l-enzimi CYP2C9, CYP2D6 u CYP3A4/5.
English: Titanium dioxide (E171) Iron oxide, yellow (E172) Iron oxide, red (E172)
Maltese: Titanium oxide (E171) Iron oxide yellow (E172) Iron oxide red (E172)
English: - The other ingredients are calcium hydrogen phosphate, crospovidone and magnesium stearate.
Maltese: - Is-sustanzi mhux attivi l-oħra huma calcium hydrogen phosphate, crospovidone u magnesium stearate.
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, clarithromycin and telithromycin) could decrease metabolism and increase imatinib concentrations.
Maltese: Dawk is-sustanzi li jinibixxu l-attivita' CYP3A4 tal-isoenzima ċitokromju P450 (eż. inibituri tal-protease 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: Imatinib in combination with chemotherapy induction (see Table 4) resulted in a complete haematological response rate of 93% (147 out of 158 evaluable patients) and in a major cytogenetic response rate of 90% (19 out of 21 evaluable patients).
Maltese: Imatinib kombinat ma' induzzjoni b'kemoterapija (ara Tabella 3) wassal għal rata ta' rispons ematoloġiku komplet ta' 93% (147 minn 158 pazjenti li setgħu jkunu evalwati) u f'rata ta' rispons citoġenetika maġġuri ta' 90% (19 minn 21 pazjenti li setgħu jkunu evalwati).
English: Study AJP01 Induction therapy
Maltese: Studju AJP01
English: Non transparent orange capsules with black marking 7629 on capsule body and black marking TEVA on capsule cap.
Maltese: Kapsuli oranġjo mhux trasparenti b'immarkar ta' 7629 iswed fuq il-korp tal-kapsula u immarkar iswed ta' TEVA fuq l-għatu tal-kapsula.
English: Imatinib Teva is indicated for
Maltese: Imatinib Teva hu indikat ghall