FrancophonIA/ELRC3.0 huggingface dataset:
English: Abbreviations: CI=confidence interval; N=number of patients; NA=not applicable; pNET=pancreatic neuroendocrine tumours; RECIST=response evaluation criteria in solid tumours.
Maltese: CI=Intervall ta' kunfidenza; N=numru ta' pazjenti; NA=Ma japplikax; pNET=tumuri newroendokrini tal-frixa; RECIST=kriterji ta' evalwazzjoni tar-rispons f'tumuri solidi.
English: Adverse reactions that were reported in GIST, MRCC, and pNET patients in a pooled dataset of 7,115 patients are listed below, by system organ class, frequency and grade of severity (NCI-CTCAE).
Maltese: Ir-reazzjonijiet avversi li kienu rrappurtati fil-pazjenti b'GIST, MRCC u pNET miġbura f'dataset ta' 7115 pazjenti huma elenkati hawn taħt, skont is-Sistema ta' Klassifika ta' l-Organi, il-frekwenza u lgrad ta' severità (NCI-CTCAE).
English: • Musculoskeletal pain (pain in muscles and bones), muscular weakness, muscular fatigue, muscle pain, muscle spasms.
Maltese: • Uġigħ muskoloskeletriku (uġigħ fil-muskoli u fl-għadam), dgħjufija fil-muskoli, għeja fil muskoli, uġigħ fil-muskoli, spażmi fil-muskoli.
English: Effect of Breast Cancer Resistance Protein (BCRP) inhibitors Limited clinical data are available on the interaction between sunitinib and BCRP inhibitors and the possibility of an interaction between sunitinib and other BCRP inhibitors cannot be excluded (see section 5.2).
Maltese: Hemm disponibbli dejta klinika limitata dwar l-interazzjoni bejn sunitinib u impedituri ta' BCRP u lpossibbiltà ta' interazzjoni bejn sunitinib u impedituri oħra ta' BCRP ma tistax tiġi eskluża (ara sezzjoni 5.2).
English: Immune system disorders Hypersensitivity reactions, including angioedema, have been reported (see section 4.4).
Maltese: Disturbi fis-sistema immuni Reazzjonijiet ta' sensittivita' eċċessiva, li jinkludu anġjoedema (ara sezzjoni 4.4).
English: Monitor liver function tests (alanine transaminase [ALT], aspartate transaminase [AST], bilirubin levels) before initiation of treatment, during each cycle of treatment, and as clinically indicated.
Maltese: Testijiet tal-funzjoni tal-fwied (alanine transaminase [ALT], aspartate transaminase [AST], livelli ta' bilirubin) għandhom jiġu mmonitorjati qabel il-bidu tal-kura, matul kull ċiklu ta' trattament, u kif indikat klinikament.
English: For GIST and MRCC, dose modifications in 12.5 mg steps may be applied based on individual safety and tolerability.
Maltese: Għal GIST u MRCC, modifikazzjonijiet fid-doża b'inkrimenti ta' 12.5 mg jistgħu jiġu applikati fuq bażi individwali ta' sigurtà u tolerabbilità.
English: In patients receiving sunitinib for treatment-naïve MRCC, 39% had bleeding events vs 11% of patients receiving interferon- (IFN-α).
Maltese: F'pazjenti li kienu qed jirċievu sunitinib għal MRCC bi trattament li qatt ma kien ittieħed qabel, 39% kellhom reazzjonijiet emorraġiċi kontra 11% tal-pazjenti li kienu qed jirċievu interferon- (IFN-α).
English: Similarly, among 57 patients in the sunitinib arm (including 28 with 1 prior systemic therapy and 29 with 2 or more prior systemic therapies) and 61 patients in the placebo arm (including 25 with 1 prior systemic therapy and 36 with 2 or more prior systemic therapies), the hazard ratio for PFS was 0.456 (95% CI: 0.264, 0.787), p=0.0036.
Maltese: Bl-istess mod, fost 57 pazjent fil-grupp li ngħata sunitinib (inklużi 28 b'terapija sistemika waħda preċedenti u 29 b'żewġ terapiji jew aktar sistemiċi preċedenti) u 61 pazjent fil-grupp li ngħata plaċebo (inklużi 25 b'terapija sistemika waħda preċedenti u 36 b'żewġ terapiji jew aktar sistemiċi preċedenti), il-proporzjon tal-periklu għal PFS kien 0.456 (95% CI: 0.264, 0.787), p = 0.0036.
English: Nine of these patients had pulmonary embolisms; 1 was Grade 2 and 8 were Grade 4.
Maltese: Disa' minn dawn il-pazjenti kellhom emboliżmu pulmonari; 1 kien ta' Grad 2 u 8 kienu ta' Grad 4.
English: Frequencies are defined as: very common (1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: Komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1//100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: In this study the objective response rate was 36.5% (95% CI: 24.7%, 49.6%) and the median TTP was 37.7 weeks (95% CI: 24.0, 46.4).
Maltese: F'dan l-istudju r-rata ta' reazzjoni oġġettiva kienet 36.5% (95% CI: 24.7%, 49.6%) u t-TTP medjan kien 37.7 ġimgħat (95% CI: 24.0, 46.4).
English: Impaired wound healing Cases of impaired wound healing have been reported during sunitinib therapy.
Maltese: Nuqqas ta' fejqan ta' feriti Każijiet ta' nuqqas ta' fejqan ta' feriti ġew irrappurtati waqt terapija b'sunitinib.
English: • Fever.
Maltese: • Fwawar.
English: • Decreased activity of thyroid gland (hypothyroidism).
Maltese: • Tnaqqis tal-attività tal-glandola tat-tirojde (ipotirojdiżmu).
English: Via del Commercio - Zona Industriale 63100 Marino del Tronto (Ascoli Piceno) Italy
Maltese: Via del Commercio - Zona Industriale63100
English: Sutent can cause thyroid gland problems.
Maltese: Sutent jista' jikkawża problemi fil-glandola tat-tirojde.
English: Based on this analysis, a dose of approximately 20 mg/m daily in paediatric patients, with BSA values between 1.10 and 1.87 m2, is expected to provide plasma exposures to sunitinib and its active metabolite comparable (between 75 and 125% of the AUC) to those in adults with GIST administered sunitinib 50 mg daily on Schedule 4/2 (AUC 1233 ng.hr/mL).
Maltese: 1.87 m 2, mistennija li tipprovdi esponiment fil-plażma għal sunitinib u l-metabolit attiv tiegħu komparabbli (bejn 75 u 125% tal-AUC) għal dak fl-adulti b'GIST mogħtija sunitinib 50 mg kuljum fuq Skeda 4/2 (AUC 1233 ng.hr/mL).
English: A clinically significant advantage in investigator-assessed PFS for sunitinib over placebo was observed.
Maltese: Kien osservat vantaġġ klinikament sinifikanti fil-PFS stmata mill-investigatur għal sunitinib fuq ilplaċebo.
English: 30 hard capsules.
Maltese: 30 kapsula iebsa.
English: Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules sunitinib
Maltese: Sutent 12.5 mg kapsuli ibsin Sutent 25 mg kapsuli ibsin Sutent 37.5 mg kapsuli ibsin Sutent 50 mg kapsuli ibsin sunitinib
English: Sunitinib and its primary active metabolite were the major compounds identified in plasma, urine, and faeces, representing 91.5%, 86.4%, and 73.8% of radioactivity in pooled samples, respectively.
Maltese: Sunitinib u l-metabolit attiv primarju tiegħu kienu l-komposti maġġuri li ġew identifikati fil-plażma, l-awrina u l-ippurgar, u rrappreżentaw 91.5%, 86.4% u 73.8% tar-radjoattività f'kampjuni ppuljati, rispettivament.
English: The most common (≥10%) treatment-related adverse events were neutrophil count decreased (6 [20.7%] patients) and haemorrhage intracranial (3[10.3%] patients).
Maltese: L-aktar reazzjonijiet avversi relatati mal-kura komuni (≥10%) kienu tnaqqis fl-għadd tan-netwrofili (6 [20.7%] pazjenti) u emorraġija intrakranjali (3[10.3%] pazjenti).
English: In this study the ORR was 35.8% (95% CI: 26.8% , 47.5 %).
Maltese: F'dan l-istudju l-ORR kienet 35.8% (95% CI: 26.
English: - Printing ink: shellac, propylene glycol, sodium hydroxide, povidone, and titanium dioxide
Maltese: - Il-linka tal-istampar: shellac, propylene glycol, sodium hydroxide, povidone u titanium dioxide
English: The PK of gefitinib (250 mg daily) and sunitinib (37.5 mg [Cohort 1, n=4] or 50 mg [Cohort 2, n=7] daily on a 4-weeks on followed by 2 weeks-off schedule) when co-administered was evaluated as a secondary study objective.
Maltese: Il-PK ta' gefitinib (250 mg kuljum) u sunitinib (37.5 mg [Koorti 1, n=4] jew 50 mg [Koorti 2, n=7] kuljum fuq skeda ta' 4 ġimgħat iva, segwit minn skeda ta' ġimagħtejn le), meta mogħti flimkien ġie evalwat bħala objettiv sekondarju tal-istudju.
English: A Phase 4 multinational, multi-centre, single-arm, open-label study evaluating the efficacy and safety of sunitinib was conducted in patients with progressive, advanced/metastatic, well-differentiated, unresectable pNET.
Maltese: Sar studju tal-Fażi 4, multinazzjonali, f'ċentri multipli, open-label li evalwa l-effikaċja u s-sigurtà ta' sunitinib f'pazjenti b'pNET progressiv, avvanzat/metastatiku, differenzjat sewwa u li ma jistax jitneħħa.
English: Core radiology assessment was discontinued after the primary endpoint had been met. At the final analysis, the ORR as determined by the investigator's assessment was 46% (95% CI: 41%, 51%) for the sunitinib arm and 12.0% (95% CI: 9%, 16%) for the IFN-α arm (p<0.001).
Maltese: Fl-analiżi finali, ilOOR determinata mill-valutazzjoni ta' l-investigatur kien 46% (95% Cl: 41%, 51%) għad-driegħ ta' sunitinib u 12.0% (95% Cl: 9%, 16%) għad-driegħ ta' IFN- (p <0.
English: The safety of continued sunitinib treatment in patients with moderate to severe proteinuria has not been systematically evaluated.
Maltese: Is-sigurtà tat-trattament kontinwu b'sunitinib f'pazjenti bi proteinurja moderata għal severa ma ġietx evalwata b'mod sistematiku.
English: A phase 2 open-label study was conducted in 29 patients comprised of 27 paediatric patients (aged 3 years to 16 years) and 2 young adult patients (aged 18 years to 19 years) with recurrent/progressive/refractory high grade glioma (HGG) or ependymoma.
Maltese: Studju ta' fażi 2 b'tikketta open-label sar f'29 pazjent li kienu jikkonsistu minn 27 pazjent pedjatriku (ta' bejn 3-16-il sena) u 2 pazjenti adulti żgħar (ta' bejn 18-19-il sena) bi glijoma ta' grad għoli (HGG, high grade glioma) rikorrenti/progressiva/refrattorja jew ependimoma.
English: CYP3A4 inhibitors/inducers
Maltese: Inibituri/induċituri ta' CYP3A4
English: All thyroid-related events reported were Grade 1-2 (see section 4.4).
Maltese: Kull avveniment li ġie rrappurtat u li kien relatat mattirojde kien ta' Grad 1-2 (ara sezzjoni 4.4).
English: The median OS was 114.6 weeks for the sunitinib arm (95% CI: 100.1, 142.9) and 94.9 weeks for the IFN-α arm (95% CI: 77.7, 117.0) with a hazard ratio of 0.821 (95% CI: 0.673, 1.001; p=0.0510 by unstratified log-rank).
Maltese: 1, 142.9) u 94.9 ġimgħat għad-driegħ ta' IFN- (95% Cl: 77.7, 117.0) bl-HR ta' 0.821 (95% Cl: 0.673, 1.001; p=0.0510 bil-log rank stratifikat).
English: Use of somatostatin analogues was allowed in the study.
Maltese: L-użu ta' analogi ta' somatostatin kien permess fl-istudju.
English: nausea, vomiting, diarrhoea, constipation, abdominal pain/swelling, loss/decrease of appetite.
Maltese: remettar, dijarea, stitikezza, uġigħ/nefħa addominali, tnaqqis fl-aptit.
English: A hazard ratio favouring sunitinib was observed in all subgroups of baseline characteristics evaluated, including an analysis by number of prior systemic therapies.
Maltese: Kien osservat proporzjon ta' riskju favur sunitinib fis-sottogruppi kollha tal-karatteristiċi bażiċi evalwati, fosthom analiżi bin-numru ta' terapiji sistemiċi preċedenti.
English: For pNET, dose modification in 12.5 mg steps may be applied based on individual safety and tolerability.
Maltese: Għal pNET, modifikazzjonijiet fid-doża b'inkrimenti ta' 12.5 mg jistgħu jiġu applikati fuq bażi individwali ta' sigurtà u tollerabbilità.
English: Evidence from a Phase 1/2 study of oral sunitinib conducted in 6 paediatric patients with GIST aged 13 years to 16 years who received sunitinib on Schedule 4/2, at doses ranging between 15 mg/m daily and 30 mg/m daily, and available published data (20 paediatric or young adult patients with GIST) indicated that sunitinib treatment resulted in disease stabilization in 18 of 26 (69.2%) patients, either after imatinib failure or intolerance (16 patients with stable disease out of 21), or de novo/after surgery (2 patients with stable disease out of 5).
Maltese: Evidenza minn studju ta' Fażi 1/2 ta' sunitinib orali li sar f'6 pazjenti pedjatriċi b'GIST ta' bejn 13-16il sena li rċivew sunitinib fuq Skeda 4/2, bid-dożi li jvarjaw bejn 15 mg/m kuljum u 30 mg/m2 kuljum, u dejta ppubblikata disponibbli (20 pazjent pedjatriku jew pazjenti adulti żgħar b'GIST) indikat li kura b'sunitinib irriżultat fi stabbilizzazzjoni tal-marda fi 18 minn 26 (69.2%) pazjent, jew wara li ma rnexxiex imatinib jew wara intolleranza (16-il pazjent b'marda stabbli minn 21), jew de novo/wara kirurġija (2 pazjenti b'marda stabbli minn 5).
English: k Acute coronary syndrome, angina pectoris, angina unstable, coronary artery occlusion, and myocardial ischaemia.
Maltese: Sindromu koronarju akut, anġina pectoris, anġina instabbli, okklużjoni tal-arterja koronarja, iskemija mijokardijaka. Frazzjoni tat-tfigħ 'il barra tad-demm mill-ventrikuli għall-arterji prinċipali mnaqqsa/anormali.
English: Population PK analyses indicated that sunitinib apparent clearance (CL/F) was not affected by creatinine clearance (CLcr) within the range evaluated (42-347 ml/min).
Maltese: Analiżi tal-PK tal-popolazzjoni indikaw li t-tneħħija apparenti (CL/F) ta' sunitinib ma kinitx effettwata mir-rata ta' tneħħija ta' creatinine (CLcr) fi ħdan il-medda evalwata (42-347 ml/min).
English: In both the clinical study and the publications, the safety profile was consistent with the known safety profile in adults.
Maltese: Kemm fl-istudju kliniku kif ukoll fil-pubblikazzjonijiet, il-profil ta' sigurtà kien konsistenti mal-profil ta' sigurtà magħruf fl-adulti.
English: In the Phase 3 pNET study, 1 (1%) patient who received sunitinib had treatment-related fatal cardiac failure.
Maltese: Fl-isudju pNET ta' Fażi 3, pazjent 1(1%) li rċieva sunitinib sofra attakk tal-qalb fatali relatat mat-trattament.
English: In patients who received sunitinib in Phase 3 registrational studies, pulmonary events (i.e. dyspnoea, pleural effusion, pulmonary embolism, or pulmonary oedema) were reported in approximately 17.8% of patients with GIST, in approximately 26.7% of patients with MRCC and in 12% of patients with pNET.
Maltese: F'pazjenti li rċivew sunitinib fi studji reġistrazzjonali ta' Fażi 3, reazzjonijiet pulmonari (i.e., dispnea, effużjoni plewrali, emboliżmu pulmonari, jew edema ulmonari) kienu rrapportati f'madwar 17.8% talpazjenti b'GIST, f'madwar 26.7% tal-pazjenti b'MRCC u fi 12% tal-pazjenti b'pNET.
English: Although sunitinib and its primary metabolite were not eliminated through haemodialysis in subjects with ESRD, the total systemic exposures were lower by 47% for sunitinib and 31% for its primary metabolite compared to subjects with normal renal function.
Maltese: Għalkemm sunitinib u l-metabolu ewlieni tiegħu ma kienux eliminati permezz ta' l-emodijalisi f'suġġetti bil-ESRD, l-esponimenti sistemiċi totali kienu anqas minn 47% għal sunitinib u 31% għallmetabolu ewlieni tiegħu meta mqabbla ma' suġġetti b'funzjoni renali normali.
English: y Face oedema, oedema, and oedema peripheral.
Maltese: Edema fil-wiċċ, edema u edema periferali.
English: T4 increase was reported in 2 (0.8%) patients on sunitinib and 1 (0.4%) patient on capecitabine.
Maltese: Żieda fit-T4 ġiet irrappurtata f'2 pazjenti (0.8%) b'sunitinib u f'pazjent 1 (0.4%) b'capecitabine.
English: The most common adverse drug reactions were gastrointestinal (GI) toxicity, neutropenia, fatigue, and ALT elevation.
Maltese: L-aktar reazzjonijiet avversi talmediċina komuni kienu tossiċità gastrointestinali (GI, gastrointestinal), newtropenja, għeja u elevazzjoni ta' ALT.
English: Rare
Maltese: Ekżema
English: Cardiac failure congestive Myocardial infarctionm,* Cardiac failure* Cardiomyopathy*
Maltese: Infart mijokardijaku m,*
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensitività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fissezzjoni 6.1.
English: HDPE BOTTLE - 25 MG CAPSULES
Maltese: TAL-HDPE - 25 MG KAPSULI
English: Co-administration of sunitinib with potent CYP3A4 inhibitors, such as ketoconazole, should be avoided (see sections 4.4 and 4.5).
Maltese: Ko-amministrazzjoni ta' sunitinib ma' impedituri CYP3A4 potenti, bħal ma huma ketoconazole, għandha tiġi evitata (ara sezzjonijiet 4.4 u 4.5).
English: Other medicines and Sutent
Maltese: Mediċini oħra u Sutent
English: Sunitinib was identified as an inhibitor of platelet-derived growth factor receptors (PDGFRα and PDGFRβ), VEGF receptors (VEGFR1, VEGFR2, and VEGFR3), stem cell factor receptor (KIT), Fms-like tyrosine kinase-3 (FLT3), colony stimulating factor receptor (CSF-1R), and the glial cell-line derived neurotrophic factor receptor (RET).
Maltese: Sunitinib kien identifikat bħala impeditur ta' riċettaturi tal-fatturi ta' l-iżvilupp li ġejjin mill-plejtlits (PDGFRα u PDGFRβ), riċettaturi VEGF (fatturi tal-iżvilupp talendotilju vaskulari - vascular endothelial growth factor) (VEGFR1, VEGFR2 uVEGFR3), riċettatur tal-fattur taċ-ċellola ta' l-għerq (KIT), Fms-like tyrosine kinase-3 (FLT3), riċettaturi tal-fattur li jistimula l-kolonji (CSF-1R), u r-riċettatur tal-fattur newrotropiku li ġej minn razza taċ-ċelloli glijali (RET).
English: The PK were similar in all solid tumours populations tested and in healthy volunteers.
Maltese: Il-PK kienu simili fil-popolazzjonijiet kollha ttestjati b'tumuri solidi u fil-voluntiera b'saħħithom.
English: The following terms have been combined: a Nasopharyngitis and oral herpes.
Maltese: Nasofarinġite u herpes orali.
English: QTc interval prolongation was investigated in a trial in 24 patients, ages 20-87 years, with advanced malignancies.
Maltese: Fi prova, it-titwil tal-intervall QTc kien mistħarreġ fi prova f''24 pazjent, bejn l-etajiet ta' 20- 87 sena, b'tumuri malinni avanzati.
English: The EMA has waived the obligation to submit the results of studies with Sutent in all subsets of the paediatric population for the treatment of kidney or renal pelvis carcinoma (excluding nephroblastoma, nephroblastomatosis, clear cell sarcoma, mesoblastic nephroma, renal medullary carcinoma, and rhabdoid tumour of the kidney) (see section 4.2).
Maltese: L-EMA rrinunzjat għall-obbligu li jigu ppreżentati r-riżultati tal-istudji b'Sutent f'kull sett talpopolazzjoni pedjatrika għat-trattament ta' karċinoma tal-kliewi jew tal-pelvi renali (esklużi nefroblastoma, nefroblastomatosi, phroblastomatosis, sarkoma taċ-ċelloli ċari, nefroma mesoblastika, karċinoma tal-medulla tal-kliewi u tumur rhabdoid tal-kliewi) (ara sezzjoni 4.2).
English: Increases in serum lipase and amylase activities were observed in patients with various solid tumours who received sunitinib.
Maltese: Żidiet fl-attivitajiet ta' lipase u amylase fis-serum kienu osservati f'pazjenti b'diversi tumuri solidi li ngħataw sunitinib.
English: Administration of sunitinib with potent CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital or herbal preparations containing St. John's Wort/Hypericum perforatum) may decrease sunitinib concentrations.
Maltese: (eż., dexamethasone, phenytoin, carbamazepine, rifampin, phenobarbital jew preparazzjonijiet tal-ħxejjex li fihom St John's Wort/Hypericum perforatum) jista' jnaqqas il-konċentrazzjonijiet ta' sunitinib.
English: In a 2-year rat carcinogenicity study (0, 0.33, 1, or 3 mg/kg/day), administration of sunitinib in 28-day cycles followed by 7-day dose-free periods resulted in increases in the incidence of phaeochromocytomas and hyperplasia in the adrenal medulla of male rats given 3 mg/kg/day following > 1 year of dosing (≥ 7.8 times the AUC in patients administered the RDD).
Maltese: Fi studju dwar il-karċinoġeniċità li sar fuq il-firien fuq tul ta' sentejn (doża ta' 0, 0.33, 1, or 3 mg/kg/kuljum), amministrazzjoni ta' sunitinib f'ċikli ta' 28 ġurnata segwiti minn perjodi ta' 7 t'ijiem fejn ma ngħatawx doża rriżultaw f'żdidiet fl-inċidenza ta' fejokromoċitoma u iperplasija filmedulla adrenali tal-firien maskili li ngħataw 3 mg/kg/kuljum segwiti minn >1 sena ta' dożaġġ (≥ 7.8 darbiet l-AUC tal-pazjenti amministrati l-RDD).
English: • Tumour lysis syndrome (TLS) - TLS consists of a group of metabolic complications that can occur during treatment of cancer.
Maltese: • Sindromu tad-diżintegrazzjoni tat-tumur (TLS) - TLS jikkonsisti minn grupp ta' kumplikazzjonijiet metaboliċi li jistgħu jseħħu matul it-trattament tal-kanċer.
English: Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules
Maltese: Sutent 12.5 mg kapsuli ibsin Sutent 25 mg kapsuli ibsin Sutent 37.5 mg kapsuli ibsin Sutent 50 mg kapsuli ibsin
English: In treatment-naïve MRCC patients receiving IFN-, 6 (2%) venous thromboembolic events were reported; 1 patient (< 1%) experienced a Grade 3 DVT and 5 patients (1%) had pulmonary embolisms, all with Grade 4.
Maltese: F'pazjenti MRCC bi trattament li qatt ma kienu ħadu qabel din il-kura u li kienu qed jieħdu IFN-, seħħew 6 (2%) reazzjonijiet tromboemboliċi venużi; pazjent 1 (<1%) esperjenza DVT Grad 3 u 5 pazjenti (1%) kellhom emboliżmu pulmonari, kollha bi Grad 4.
English: Stomatitiso Abdominal painp
Maltese: Skumdità addominali Emorraġija firrektum
English: Brunner's glands carcinoma occurred in the duodenum at ≥ 1 mg/kg/day in females and at 3 mg/kg/day in males, and mucous cell hyperplasia was evident in the glandular stomach at 3 mg/kg/day in males, which occurred at ≥ 0.9, 7.8, and 7.8 times the AUC in patients administered the RDD, respectively.
Maltese: Il-karċinoma tal-glandoli Brunner seħħ fil-duwodenu tal-firien femminili f'doża ta' ≥1 mg/kg/kuljum u tal-firien maskili f'doża ta' 3 mg/kg/kuljum, u iperplażja taċ-ċelluli mukużi kienet evidenti fil-glandoli tal-istonku f'doża ta' 3 mg/kg/kuljum filfirien maskili, li seħħew f' ≥0.9, 7.8 u 7.8 darbiet l-AUC tal-pazjenti amministrati l-RDD, rispettivament.
English: Treatment-related venous thromboembolic events were reported in approximately 1.0% of patients with solid tumours who received sunitinib on clinical trials, including GIST and RCC.
Maltese: Reazzjonijiet tromboemboliċi venużi, relatati mat-trattament, kienu rrappurtati bejn wieħed u ieħor f' 1.0% tal-pazjenti b'tumuri solidi, li rċevew sunitinib fi studji kliniċi, inklużi GIST u RCC.
English: In a 1-month, oral gavage dose-range finding study (0, 10, 25, 75, or 200 mg/kg/day) with continuous daily dosing in rasH2 transgenic mice, carcinoma and hyperplasia of Brunner's glands of the duodenum were observed at the highest dose (200 mg/kg/day) tested.
Maltese: Fi studju ta' riċerka fuq tul ta' xahar b'medda ta' dożi li ngħataw b'mod orali permezz ta' pajp minn ġol-ħalq (0, 10, 25, 75, or 200 mg/kg/kuljum) b'CDD fi ġrieden transġeniċi rasH2, karċinoma u iperplasija tal-glandoli Brunner tad-duwodenu kienu osservati bid-doża l-aktar għolja li kienet ittestjata (200 mg/kg/kuljum).
English: In healthy volunteers, concomitant administration of a single dose of sunitinib with the CYP3A4 inducer rifampicin resulted in a reduction of the combined [sunitinib + primary metabolite] Cmax and AUC0- values of 23% and 46%, respectively.
Maltese: F'voluntiera b'saħħithom, l-għoti konkomitanti ta' doża waħda ta' sunitinib mal-induttur ta' CYP3A4, rifampin, irriżulta fi tnaqqis fil-valuri kombinati [sunitinib + metabolit primarju] Cmax u AUC0- ta' 23% u 46%, rispettivament.
English: Cases of pyoderma gangrenosum, generally reversible after discontinuation of sunitinib, have been reported (see also section 4.4).
Maltese: Każijiet ta' pyoderma gangrenosum, ġeneralment riversibbli wara li jitwaqqaf sunitinib, kienu rrapurtati (ara wkoll sezzjoni 4.4).
English: • High blood pressure.
Maltese: • Pressjoni għolja.
English: • Increased blood level of enzyme (creatine phosphokinase) from muscle.
Maltese: • Żieda fil-livell ta' enzima (creatine phosphokinase) fid-demm mill-muskoli.
English: b Bronchitis, lower respiratory tract infection, pneumonia, and respiratory tract infection.
Maltese: Bronkite, infezzjoni fl-apparat respiratorju t'isfel, pnewmonja u infezzjoni fl-apparat respiratorju.