FrancophonIA/ELRC3.0 huggingface dataset:
English: Fatal gastrointestinal bleeding was reported in 0.98% of patients receiving placebo in the GIST Phase 3 study.
Maltese: Emorraġija gastrointestinali fatali kienet irrapportata f'0.98% tal-pazjenti li kienu qed jirċievu plaċebo fl-istudju GIST ta' Fażi 3.
English: Hypothyroidism
Maltese: Anġjoedim
English: No subjects experienced an effect on the QTc interval greater than Grade 2 (CTCAE version 3.0) (see section 4.4).
Maltese: L-ebda individwu ma esperjenza effett akbar fuq l-intervall QTc minn Grad 2 (CTCAE verżjoni 3.0) (ara sezzjoni 4.4).
English: Tumour lysis syndrome*
Maltese: Sindromu taddiżintegraz zjoni tattumur*
English: Viral infectionsa
Maltese: Infezzjonijiet u infestazzjonijiet
English: • Inflammation of the colon (colitis, colitis ischaemic).
Maltese: • Infjammazzjoni tal-kolon (kolite, kolite iskemika).
English: Renal function
Maltese: Insuffiċjenza renali
English: BLISTER - 25 MG CAPSULES
Maltese: FOLJA- 25MG KAPSULI
English: The clinical safety and efficacy of sunitinib has been studied in the treatment of patients with GIST who were resistant to imatinib (i.e., those who experienced disease progression during or following treatment with imatinib) or intolerant to imatinib (i.e., those who experienced significant toxicity during treatment with imatinib that precluded further treatment), the treatment of patients with MRCC, and the treatment of patients with unresectable pNET.
Maltese: Is-sigurtà u l-effikaċja klinika ta' sunitinib ġiet studjata fit-trattament ta' pazjenti b'GIST li kienu reżistenti għal imatinib (i.e. dawk li esperjenzaw progressjoni tal-marda waqt jew wara trattament b'imatinib) jew intoleranti għal imatinib (i.e. dawk li esperjenzaw tossiċità sinifikattiva waqt trattament b'imatinib li pprekluda aktar trattament), it-trattament ta' pazjenti b'MRCC u t-trattament ta' pazjenti b'pNET li ma jistax jitneħħa.
English: Administration of sunitinib with potent CYP3A4 inhibitors (e.g., ritonavir, itraconazole, erythromycin, clarithromycin, grapefruit juice) may increase sunitinib concentrations.
Maltese: (eż. ritonavir, itraconazole, erythromycin, clarithromycin, meraq tal-grejpfrut) tista' żżid il-konċentrazzjonijiet ta' sunitinib.
English: Neutropoenia Thrombocytopoenia Anaemia
Maltese: Newtropenja Tromboċitopenja Anemija Lewkopenija
English: The most serious adverse reactions associated with sunitinib, some fatal, are renal failure, heart failure, pulmonary embolism, gastrointestinal perforation, and haemorrhages (e.g., respiratory tract, gastrointestinal, tumour, urinary tract, and brain haemorrhages).
Maltese: L-aktar reazzjonijiet avversi serji importanti assoċjati ma' sunitinib, xi wħud fatali, huma insuffiċjenza renali, insuffiċjenza tal-qalb, emboliżmu pulmonari, perforazzjoni gastrointestinali u emorraġiji (e.ż. emorraġiji fil-passaġġ respiratorju, emorraġiji gastrointestinali u emorraġiji tat-tumur, emorraġiji urinarji u fil-moħħ).
English: Ninety-seven patients were enrolled at various doses and schedules; 55 patients received 50 mg at the recommended treatment Schedule 4 weeks on /2 weeks off (“Schedule 4/2”).
Maltese: Sebgħa u disgħin pazjent kienu elenkati b'diversi dożi u skedi; 55 pazjent ingħataw 50 mg skond Skeda ta' trattament irrakkomandata 4 ġimgħat fuq/2 ġimgħat mingħajr (“Skeda 4/2”).
English: In the treatment-naïve MRCC study, 27% of patients on sunitinib and 15% of patients on IFN- had an LVEF value below the lower limit of normal.
Maltese: Fl-istudju MRCC ta' trattament fuq pazjenti li qatt ma kienu ħadu qabel din il-kura, 27% ta' pazjenti fuq sunitinib u 15% tal-pazjenti IFN- kellhom il-valur tal-LVEF taħt il-limitu t'isfel tan-normal.
English: Patients were required to have documented progression, based on RECIST, within the prior 12 months and were randomised (1:1) to receive either 37.5 mg sunitinib once daily without a scheduled rest period (N = 86) or placebo (N = 85).
Maltese: Il-pazjenti kienu meħtieġa li jkollhom progressjoni dokumentata, ibbażata fuq RECIST, fit-tnax-il xahar ta' qabel u ġew randomizzati (1:1) biex jirċievu jew 37.5 mg sunitinib darba kuljum mingħajr perjodu skedat ta' mistrieħ (n = 86) jew plaċebo (n = 85).
English: Hepatotoxicity has been observed in patients treated with sunitinib.
Maltese: Tossiċità tal-fwied ġiet osservata f'pazjenti kkurati b'sunitinib.
English: Renal failure* Renal failure acute* Chromaturia Proteinuria
Maltese: Insuffiċjenza renali akuta Kromaturja Proteina fl-awrina
English: Four out of 6 patients (66.7%) experienced Grade 3-4 treatment-related adverse events (Grade 3 hypophosphataemia, neutropenia, and thrombocytopenia in 1 patient each and a Grade 4 neutropenia in 1 patient).
Maltese: Fl-istess studju, 4 minn 6 pazjenti (66.7%) esperjenzaw reazzjonijiet avversi relatati mal-kura ta' Grad 3-4 (ipofosfatemija, newtropenja, u tromboċitopenja ta' Grad 3 f'pazjent 1 kull wieħed u newtropenja ta' Grad 4 f'pazjent 1).
English: Sutent 25 mg hard capsules EU/1/06/347/002
Maltese: Sutent 25 mg kapsuli ibsin EU/1/06/347/002
English: n Oropharyngeal and pharyngolaryngeal pain.
Maltese: Ċellulite u infezzjoni fil-ġilda.
English: The other ingredients are: - Capsule content: mannitol (E421), croscarmellose sodium, povidone (K-25), and magnesium stearate.
Maltese: - Il-kontenut tal-kapsula: mannitol (E421), croscarmellose sodium, povidone (K-25) u magnesium stearate.
English: After oral administration of sunitinib, Cmax are generally observed from 6 to 12 hours time to maximum concentration (tmax) postadministration.
Maltese: Wara l-għoti mill-ħalq ta' sunitinib, Cmax huma ġeneralment osservati minn 6 sa 12-il siegħa ħin għal konċentrazzjoni massima (tmax) wara l-għoti.
English: Abbreviations: CI=confidence interval; ITT=intent-to-treat; NA=not applicable; ORR=objective response rate; OS=overall survival; PFS=progression-free survival; TTP=time-to-tumour progression.
Maltese: OS=sopravivenza totali; PFS= sopravivenza ħielsa mill-progressjoni; TTP=żmien sal progressjoni tat-tumur.
English: In addition, 24% of sunitinib patients had received somatostatin analogues compared with 22% of placebo patients.
Maltese: Barra minn hekk, 24% tal-pazjenti fuq sunitinib kienu rċevew analogi ta' somatostatin meta mqabbel ma' 22% tal-pazjenti fuq plaċebo.
English: A pivotal Phase 3, multi-centre, international, randomised, double-blind, placebo-controlled study of single-agent sunitinib was conducted in patients with unresectable pNET.
Maltese: Sar studju pivitali internazzjonali, multiċentri, randomizzat, double-blind, ikkontrollat bi plaċebo, ta' Fażi 3, tas-sustanz unika sunitinib f'pazjenti li kellhom pNET li ma setax jitneħħa.
English: • Life-threatening infection of the soft tissue including the ano-genital region (see section 2).
Maltese: • Infezzjoni tat-tessuti rotob inklużi dawk fil-parti ano-ġenitali li tipperikola l-ħajja (ara sezzjoni 2).
English: Two patients (< 1%) who received sunitinib were diagnosed with CHF.
Maltese: Żewġ pazjenti (< 1%) li ngħataw sunitinib kienu dijanjożati b'CHF.
English: Flushing
Maltese: FLIXKUN
English: If this is not possible, the dose of Sutent may need to be reduced to a minimum of 37.5 mg daily for GIST and MRCC or 25 mg daily for pNET, based on careful monitoring of tolerability (see section 4.2).
Maltese: Jekk dan mhuwiex possibbli, id-doża ta' Sutent jista' jkollu bżonn jiġi mnaqqas għal minimu ta' 37.5 mg kuljum għal GIST u MRCC jew 25 mg kuljum għal pNET, ibbażat fuq sorveljanza bir-reqqa tat-tolerabbilità (ara sezzjoni 4.2).
English: Decreased platelet counts of Grade 3 and 4 severities, respectively, were reported in 3.7% and 0.4% of patients on the Phase 3 GIST study, in 8.2% and 1.1% of patients on the Phase 3 MRCC study, and in 3.7% and 1.2% of patients on the Phase 3 pNET study (see section 4.4).
Maltese: Ġie rrapportat tnaqqis fl-għadd assolut tan-newtrofili ta' severitajiet ta' Grad 3 u 4, rispettivament, f'10% u 1.7% tal-pazjenti fl-istudju GIST ta' Fażi 3, f'16% u 1.6% tal-pazjenti fl-istudju MRCC ta' Fażi 3, u fi 13% u 2.4% tal-pazjenti fl-istudju pNET ta' Fażi 3. Ġie rrapportat tnaqqis fl-għadd ta' pjastrini ta' severitajiet ta' Grad 3 u 4, rispettivament, f'3.7% u 0.4% tal-pazjenti fl-istudju GIST ta' Fażi 3, fi 8.2% u 1.1% tal-pazjenti fl-istudju MRCC ta' Fażi 3, u fi 3.7% u 1.2% tal-pazjenti fl-istudju pNET ta' Fażi 3 (ara sezzjoni 4.4)
English: Haemorrhage urinary tract
Maltese: Emorraġija filpassaġġ urinarju
English: A Phase 1 dose-escalation study of oral sunitinib was conducted in 35 patients comprised of 30 paediatric patients (aged 3 years to 17 years) and 5 young adult patients (aged: 18 years to 21 years), with refractory solid tumours, the majority of whom were enrolled with a primary diagnosis of brain tumour.
Maltese: Studju ta' eskalazzjoni tad-doża ta' Fażi 1 ta' sunitinib orali sar f'35 pazjent li kienu jikkonsistu minn 30 pazjent pedjatriku (li għandhom bejn 3-17-il sena) u 5 adulti żgħar (li għandhom bejn 18-21 sena), b'tumuri solidi refrattarji, li l-maġġoranza tagħhom kienu rreġistrati b'dijanjosi primarja ta' tumur filmoħħ.
English: Sutent 50 mg hard capsules sunitinib
Maltese: Sutent 50 mg kapsuli ibsin sunitinib
English: A supportive Phase 2, open-label, multi-centre study evaluated the efficacy and safety of single-agent sunitinib 50 mg daily on Schedule 4/2 in patients with unresectable pNET.
Maltese: Studju ta' sostenn, open-label, multiċentri, ta' Fażi 2, evalwa l-effikaċja u s-sigurtà tas-sustanz unika sunitinib 50 mg kuljum fuq Skeda 4/2 f'pazjenti li kellhom pNET li ma jistax jitneħħa.
English: Detailed information on this medicine is available on the European Medicine Agency website: http://www.ema.europa.eu.
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu.
English: • Extreme tiredness, loss of strength.
Maltese: • Għeja estrema, tħossok bla saħħa.
English: Sutent 50 mg hard capsules EU/1/06/347/003
Maltese: Sutent 50 mg kapsuli ibsin EU/1/06/347/003
English: In GIST patients ‘cardiac failure', ‘cardiac failure congestive', or ‘left ventricular failure' were reported in 1.2% of patients treated with sunitinib and 1% of patients treated with placebo.
Maltese: Fil-pazjenti GIST, ‘falliment kardijaku', ‘falliment kardijaku konġestiv' jew ‘falliment ventrikulari xellugi' kienu rrapportati f'1.2% tal-pazjenti ttrattati b'sunitinib u 1% ta' pazjenti ttrattati bi plaċebo.
English: While you are on this medicine "pyoderma gangrenosum" (painful skin ulceration) or “necrotising fasciitis” (rapidly spreading infection of the skin/soft tissue that may be life-threatening) may occur.
Maltese: Waqt li qed tieħu din il-mediċina, jista' jkollok “pyoderma gangrenosum” (ulċerazzjoni tal-ġilda bl-uġigħ) jew “faxxite nekrotizzanti” (infezzjoni tal-ġilda/tessut artab li tinfirex malajr u li tista' tkun ta'
English: Effects on male fertility in rat were observed in the form of tubular atrophy in the testes, reduction of spermatozoa in epididymides, and colloid depletion in prostate and seminal vesicles at plasma exposure levels 25 times the systemic exposure in humans.
Maltese: Fil-far effetti fuq il-fertilità tar-raġel kienu osservati fil-forma ta' atrofija tubulari fit-testikoli, tnaqqis flispermatożoa fl-epididimi u żvujtar tal-kollojde fil-prostata u vesikli seminali fl-livelli ta' esponiment fil-plażma 25 darba aktar mill-esponiment sistemiku fil-bniedem.
English: OS (weeks)
Maltese: OS (ġimgħat)
English: Colitis and colitis ischaemic.
Maltese: Kolite u kolite iskemika.
English: By Day 14, combined plasma concentrations of sunitinib and its active metabolite are 62.9-101 ng/ml, which are target concentrations predicted from preclinical data to inhibit receptor phosphorylation in vitro and result in tumour stasis/growth reduction in vivo.
Maltese: Sa Jum 14, il-konċentrazzjonijiet kombinati fil-plażma ta' sunitinib u l-metabolitattiv tiegħu huma 62.9 - 101 ng/ml li huma konċentrazzjonijiet fil-mira previsti minn tagħrif ta' qabel l-użu kliniku sabiex jimpedixxu l-fosforilazzjoni tar-riċetturi in vitro u jirriżultaw fi stasi/tnaqqis tat-tkabbir tat-tumur in vivo.
English: Hypothyroidism was reported as an adverse reaction in 7 patients (4%) receiving sunitinib across the 2 cytokine-refractory MRCC studies; in 61 patients (16%) on sunitinib and 3 patients (< 1%) in the IFN- arm in the treatment-naïve MRCC study.
Maltese: L-ipotirojdiżmu kien irrapportat bħala reazzjoni avversa f'7 pazjenti (4%) li rċevew sunitinib matul iż2 studji ta' MRCC refrattarja għaċ-ċitokini; f'61 pazjent (16%) fuq sunitinib u fi 3 pazjenti (<1%) fiddriegħ IFN- fl-istudju MRCC fi trattament li qatt ma kien ittieħed qabel.
English: • Fluid retention including around the lungs.
Maltese: • Jinġema' fluwidu inkluż madwar il-pulmun.
English: Among age and bodysize related covariates tested, age was a significant covariate on apparent clearance of sunitinib (the younger the age of the paediatric patient, the lower the apparent clearance).
Maltese: Fost il-kovarjanti relatati tal-età u tad-daqs tal-ġisem ittestjati, l-età kienet kovarjant sinifikanti fuq ittneħħija apparenti ta' sunitinib (iktar kemm tkun baxxa l-età, iktar tkun baxxa t-tneħħija apparenti).
English: Each capsule contains sunitinib malate, equivalent to 37.5 mg of sunitinib.
Maltese: Kull kapsula fiha sunitinib malate, ekwivalenti għal 37.5 mg ta' sunitinib.
English: Seven hundred and fifty patients were randomised 1:1 to the treatment arms; they received treatment with either sunitinib in repeated 6-week cycles, consisting of 4 weeks of 50 mg daily oral administration followed by 2 weeks of rest (Schedule 4/2), or IFN-α, administered as a subcutaneous injection of 3 million units (MU) the first week, 6 MU the second week, and 9 MU the third week and thereafter, on 3 nonconsecutive days each week.
Maltese: Seba' mija u ħamsin pazjent kienu randomizzati 1:1 għad-dirgħajn ta' trattament; huma ngħataw trattament jew b'sunitinib f'ċikli rrepetuti ta' 6-ġimgħat, magħmula minn 4 ġimgħat ta' amministrazzjoni orali ta' 50 mg kuljum segwita minn ġimagħtejn ta' mistrieħ (Skeda 4/2), jew b'IFN-α, amministrat bħala injezzjoni taħt il-ġilda ta' 3 miljun junits (MU) fl-ewwel ġimgħa, u 9 MU fit-tielet ġimgħa u minn hemm ‘l hemm fuq 3 ijiem mhux konsekuttivi kull ġimgħa.
English: If this is not possible, the dose of sunitinib may need to be increased in 12.5 mg steps (up to 87.5 mg per day for GIST and MRCC or 62.5 mg per day for pNET) based on careful monitoring of tolerability.
Maltese: Jekk dan mhux possibbli, id-doża ta' sunitinib tista' tkun meħtieġa li tiżdied b'inkrimenti ta' 12.5 mg (sa 87.5 mg kuljum għal GIST u MRCC jew 62.5 mg kuljum għal pNET) ibbażata fuq sorveljanza bir-reqqa tat-tolerabbilità.
English: Of patients receiving sunitinib for cytokine-refractory MRCC, 26% experienced bleeding.
Maltese: Mill-pazjenti li kienu qed jirċievu sunitinib għal għal MRCC refrattarja għaċ-ċitokini, 26% esperjenzaw emorraġija.
English: Efficacy is based on time-to-tumour progression (TTP) and an increase in survival in GIST, on progression-free survival (PFS) and objective response rates (ORR) for treatment-naïve and cytokine-refractory MRCC respectively, and on PFS for pNET.
Maltese: L-effikaċja hija bażata fuq iż-żmien sal-progressjoni tat-tumur (TTP) u żieda fis-sopravivenza f'GIST, fuq sopravivenza ħielsa mill-progressjoni (PFS, progression-free survival) u rati ta' reazzjoni oġġettivi (ORR, objective response rates) għal MRCC bi trattament li qatt ma kien ittieħed qabel u refrattarja għaċ-ċitokini, rispettivament, u fuq PFS għal pNET.
English: However, in repeated-dose toxicity studies performed in rats and monkeys, effects on female fertility were observed in the form of follicular atresia, degeneration of corpora lutea, endometrial changes in the uterus, and decreased uterine and ovarian weights at clinically relevant systemic exposure levels.
Maltese: Madankollu, fi studji ta' tossiċita b'dożi ripetuti fil-firien u fix-xadini, effetti fuq il-fertiltà kienu osservati fil-forma ta' atrijżja follikulari, deġenerazzjoni ta' corpora lutea, bidliet endometrijali fl-utru u tnaqqis fil-piżijiet ta' l-utri u l-ovarji fl-livelli ta' esponiment sistemiku klinikament rilevanti.
English: In the presence of clinical manifestations of CHF, discontinuation of sunitinib is recommended.
Maltese: Fil-preżenza ta' manifestazzjonijiet kliniċi ta' CHF, it-twaqqif ta' sunitinib hija rakkomandata.
English: Abdominal distension Abdominal discomfort Rectal haemorrhage Gingival bleeding Mouth ulceration Proctalgia
Maltese: Il-professjonisti dwar il-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
English: With repeated daily administration, sunitinib accumulates 3- to 4-fold and its primary active metabolite accumulates 7- to 10-fold.
Maltese: B'għoti ripetut ta' kuljum, sunitinib jakkumula bi 3 għal 4 darbiet u l-metabolit attiv primarju tiegħu jakkumula b'7 għal 10 darbiet.
English: • Excessive reaction to an allergen including hay fever, skin rash, itchy skin, hives, swelling of body parts, and trouble breathing.
Maltese: • Reazzjoni eċċessiva għall-allergen inkluż hay fever, raxx tal-ġilda, ħakk fil-ġilda, ħorriqija,
English: Population PK analyses of a pooled dataset from adult patients with GIST and solid tumours and paediatric patients with solid tumours were completed.
Maltese: Analiżi PK tal-popolazzjoni ta' sett tad-dejta miġbura minn pazjenti adulti b'GIST u b'tumuri solidi u pazjenti pedjartiċi b'tumuri solidi ġew imwettqa.
English: 12.5 mg hard capsules Each capsule contains sunitinib malate, equivalent to 12.5 mg of sunitinib.
Maltese: 12.5 mg kapsuli ibsin Kull kapsula fiha sunitinib malate, ekwivalenti għal 12.5 mg ta' sunitinib.
English: Thirteen patients (3%) receiving sunitinib in the Phase 3 treatment-naïve MRCC study and 4 patients (2%) on the 2 cytokine-refractory MRCC studies had venous thromboembolic events reported.
Maltese: Tlettax-il pazjent (3%) li ngħataw sunitinib fit-tielet Fażi tal-istudju MRCC għal trattament li qatt ma kienu ħadu qabel din il-kura, u 4 pazjenti (2%) fuq iż-2 studji MRCC refrattarja għaċ-ċitokini kellhom reazzjonijiet tromboemboliċi venużi rrapportati.
English: Risk factors associated with renal impairment/failure in patients receiving sunitinib included, in addition to underlying RCC, older age, diabetes mellitus, underlying renal impairment, cardiac failure, hypertension, sepsis, dehydration/hypovolaemia, and rhabdomyolysis.
Maltese: Fatturi ta' riskju assoċjati ma' indeboliment/ insuffiċjenza renali f'pazjenti li qed jirċievu sunitinib, flimkien ma' RCC diġà eżistenti, kienu jinkludu età ikbar, dijabete mellitus, indeboliment renali diġà eżistenti, falliment tal-qalb, pressjoni għolja, sepsis, deidrazzjoni /tnaqqis fil-volum tad-demm, u rabdomijoliżi.
English: Additionally, thyroid-stimulating hormone (TSH) elevations were reported in 4 cytokine-refractory MRCC patients (2%).
Maltese: Barra minn hekk, żidiet fl-ormon li jistimula t-tirojde (TSH) kienu rrapportati f'4 pazjenti b'MRCC refrattarja għaċ-ċitokini (2%).
English: Patients with seizures and signs/symptoms consistent with posterior reversible leukoencephalopathy syndrome (RPLS), such as hypertension, headache, decreased alertness, altered mental functioning and visual loss, including cortical blindness, should be controlled with medical management including control of hypertension.
Maltese: Pazjenti b'aċċessjonijiet u sinjali/sintomi konsistenti ma' sindrome ta' lewkoenċefalopatija riversibbli posterjuri (RPLS, posterior reversible leukoencephalopathy syndrome) bħal ma huma pressjoni għolja, uġigħ ta' ras, viġilanza mnaqqsa, tibdil fil-funzjoni mentali u telf talvista, inkluża għama kortikali għandhom jiġu kkontrollati b'ġestjoni medika inkluż il-kontroll ta' pressjoni għolja.
English: Bleeding events were reported in 18% of patients receiving sunitinib in a Phase 3 GIST study vs 17% of patients receiving placebo.
Maltese: Ġew irrapportati reazzjonijiet emorraġiċi fi 18% tal-pazjenti li kienu qed jirċievu sunitinib fi studju GIST ta' Fażi 3 kontra 17% tal-pazjenti li kienu qed jirċievu l-plaċebo.
English: Sutent 12.5 mg is supplied as hard gelatin capsules with orange cap and orange body, printed with white ink “Pfizer” on the cap, “STN 12.5 mg” on the body, containing yellow to orange granules.
Maltese: Sutent 12.5 mg kapsuli ibsin Kapsuli tal-ġelatina b'għatu oranġjo u bil-parti ewlenija oranġjo, bilkelma “Pfizer” stampata b'inka bajda fuq l-għatu, “STN 12.5 mg” fuq il-parti ewlenija, u li fihom granijiet safrani għal oranġjo.
English: Patients who presented with cardiac events within 12 months prior to sunitinib administration, such as myocardial infarction (including severe/unstable angina), coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF), cerebrovascular accident or transient ischaemic attack, or pulmonary embolism were excluded from all sunitinib clinical studies.
Maltese: Pazjenti li ppreżentaw b'reazzjonijiet kardijaċi, bħal ma huwa infart mijokardjali (inklużi anġina qawwija/instabbli), graft bajpass ta'arterja koronarja/periferali, kollass konġestiv tal-qalb (CHF, congestive heart failure) sintomatiku, aċċident ċerebrovaskulari u attaki iskemiċi li jgħaddu, jew emboliżmu pulmonari, fi żmien 12-il xahar qabel l-għoti ta' sunitinib,kienu esklużi mill-istudji kliniċi kollha ta' sunitinib.
English: Pancreatic neuroendocrine tumours
Maltese: Tumuri newroendokrinali fil-frixa
English: Each capsule contains sunitinib malate, equivalent to 50 mg of sunitinib.
Maltese: Kull kapsula fiha sunitinib malate, ekwivalenti għal 50 mg sunitinib.
English: Sutent 50 mg hard capsules
Maltese: Sutent 50 mg kapsuli ibsin
English: Sunitinib treatment in rats during organogenesis resulted in developmental effects at  5 mg/kg/day consisting of increased incidence of foetal skeletal malformations, predominantly characterised as retarded ossification of thoracic/lumbar vertebrae and occurred at plasma exposure levels 5.5 times the systemic exposure in humans.
Maltese: predominantament karatterizzati bħala dewmien fl-ossifikazzjoni tal-vertebre toraċiċi/lumbari u seħħew fl-livelli ta'esponiment fil-plażma 5.5 darbiet aktar mill-esponiment sistemiku fil-bniedem.
English: An initial open-label, dose-escalation study was conducted in patients with GIST after failure of imatinib (median maximum daily dose 800 mg) due to resistance or intolerance.
Maltese: Studju inizjali b'tikketta open-label u b'eskalazzjoni tad-doża kien magħmul f'pazjenti b'GIST wara falliment ta' imatinib (doża medjana massima ta' kuljum 800 mg) minħabba reżistenza jew intoleranza.
English: Sutent 25 mg hard capsules sunitinib
Maltese: Sutent 25 mg kapsuli ibsin sunitinib
English: Paediatric population Experience on the use of sunitinib in paediatric patients is limited (see section 4.2).
Maltese: L-esprejenza dwar l-użu ta' sunitinib f'pazjenti pedjatriċi hija limitata (ara sezzjoni 4.2).
English: Kidney disorders.
Maltese: Mhux applikabbli.
English: Concomitant administration of sunitinib with potent CYP3A4 inhibitors should be limited because of the possible increase in sunitinib plasma concentrations (see sections 4.2, 4.5 and 4.8).
Maltese: L-għoti konkomitanti ta' sunitinib ma' impedituri qawwija ta' CYP3A4, għandu jkun limitat minħabba ż-żieda li jista' jkun hemm fil-konċentrazzjonijiet ta' sunitinib fil-plażma (ara sezzjonijiet 4.2, 4.5 u 4.8).
English: Necrotising fasciitis*
Maltese: Faxxite nekrotizzanti* Infezzjonijiet batterjali
English: • Pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth.
Maltese: • Sensazzjoni anormali fil-ġilda, ħakk, qxur fil-ġilda u ffjammazzjoni, bżieżaq, akne, id-dwiefer jitilfu l-kulur, titlef ix-xagħar.
English: Dizziness Headache Taste disturbancej
Maltese: Stomatite u stomatite aphtous.
English: Vomiting Diarrhoea Dyspepsia Nausea Constipation
Maltese: Infezzjonijiet flapparat urinarju Infezzjonijiet talġilda
English: Hypertension was reported in 26.5% of patients receiving sunitinib in a Phase 3 pNET study, compared to 4.9% of patients receiving placebo.
Maltese: 5% tal-pazjenti li rċevew sunitinib fi studju pNET ta' Fażi 3, meta pparagunat ma' 4.9% talpazjenti li rċevew plaċebo.