FrancophonIA/ELRC3.0 huggingface dataset:
English: In rat and monkey repeated-dose toxicity studies up to 9-months duration, the primary target organ effects were identified in the gastrointestinal tract (emesis and diarrhoea in monkeys); adrenal gland (cortical congestion and/or haemorrhage in rats and monkeys, with necrosis followed by fibrosis in rats); haemolymphopoietic system (bone morrow hypocellularity and lymphoid depletion of thymus, spleen, and lymph node); exocrine pancreas (acinar cell degranulation with single cell necrosis); salivary gland (acinar hypertrophy); bone joint (growth plate thickening); uterus (atrophy); and ovaries (decreased follicular development).
Maltese: Fi studji ta' tossiċità b'dożi ripetuti fil-firien u x-xadini fuq tul ta' żmien ta' 9 xhur, l-organi mmirati primarji kienu identifikati fil-passaġġ gastrointestinali (remettar u dijarea fix-xadini); glandola adrenali (konġestjoni kortikali u/jew emorraġija fil-firien u fix-xadini, b'nekrożi segwita minn fibrożi filfirien); sistema emolimfopojetika (ipoċellolarità tal-mudullun, u żvujtar limfojde tat-tajmus, milsa, u glandoli limfatiċi); frixa eżokrina (degranulazzjoni ta' ċelloli aċinari b'nekrożi ta' ċellola waħda); glandola salivarja (ipertrofija aċinari); ġoġi ta' l-għadam (tħaxxin tas-saff ta' l-iżvilupp); utru
English: A Phase 3, randomised, double-blind, placebo-controlled study of sunitinib was conducted in patients with GIST who were intolerant to, or had experienced disease progression during or following treatment with imatinib (median maximum daily dose 800 mg).
Maltese: Studju ta' Fażi 3, randomised, double-blind, b'kontrolli bi plaċebo ta' sunitinib kien magħmul f'pazjenti b'GIST li kienu intolleranti għal, jew li esperjenzaw progressjoni tal-marda waqt jew wara trattament b'imatinib (doża medjana massima ta' kuljum 800 mg).
English: Physicians are advised to weigh this risk against the potential benefits of sunitinib.
Maltese: Analażi mhux stratifikata Proporzjon ta' riskju (sunitinib versus IFN
English: Sutent 37.5 mg hard capsules sunitinib
Maltese: Sutent 37.5 mg kapsuli ibsin sunitinib
English: GIST summary of efficacy endpoints (ITT population) Double-blind treatment a
Maltese: GIST sommarju tal-punti ta' tmiem fuq l-effikaċja (popolazzjoni ITT) Trattament double-blind Medjan (95% CI)
English: In the pivotal Phase 3 GIST study (N = 312), treatment-related fatal cardiac reactions were reported in 1% of patients on each arm of the study (i.e. sunitinib and placebo arms).
Maltese: Fit-Fażi 3 tal-istudju pivotali GIST (n = 312), reazzjonijiet kardijaċi fatali relatati mal-kura seħħew f'1% tal-pazjenti f'kull taqsima tal-studju (i.e. taqsima b'sunitinib u bi plaċebo).
English: Additional effects observed in other studies included: QTc interval prolongation, LVEF reduction and testicular tubular atrophy, increased mesangial cells in kidney, haemorrhage in gastrointestinal tract and oral mucosa, and hypertrophy of anterior pituitary cells.
Maltese: Effetti addizzjonali, osservati fi studji oħra inkludew titwil ta' l-interval QTc, tnaqqis fl-LVEF u atrofija tubulari testikolari, żidiet fiċ-ċelloli mesangjali filkilwa, emorragija fil-passaġġ gastro-intestinali u mukoża orali, u ipertrofija taċ-ċelloli pitwitarji anterjuri.
English: A total of 29 patients in the sunitinib arm and 24 in the placebo arm had received no prior systemic treatment; among these patients, the hazard ratio for PFS was 0.365 (95% CI: 0.156, 0.857), p=0.0156.
Maltese: Total ta' 29 pazjent fil-grupp li ngħata sunitinib u 24 fil-grupp li ngħata plaċebo ma kienu rċevew lebda trattament sistemiku preċedenti; fost dawn il-pazjenti, il-proporzjon tal-periklu għal PFS kien 0.365 (95% CI: 0.156, 0.857), p = 0.0156.
English: A total of 59 out of 85 patients (69.4%) from the placebo arm crossed over to open-label sunitinib following disease progression or unblinding at study closure.
Maltese: Total ta' 59 minn 85 (69.4%) pazjent mill-grupp li kien ħa l-plaċebo nqalbu għall-open-label sunitinib wara lprogressjoni tal-marda jew unblinding fl-għeluq tal-istudju.
English: Dehydration Hypoglycaemia
Maltese: Deidrazzjoni Ipogliċemija
English: Treatment-related serious adverse events (TRSAEs) were reported in 23.7% of patients receiving sunitinib and in 6.9% of patients receiving IFN-α.
Maltese: Reazzjonijiet avversi serji li huma relatati mat-trattament (TRSAEs), kienu rappurtati f'23.7% tal-pazjenti li qed jirċievu sunitinib u f'6.9% tal-pazjenti li qed jirċievu IFN-.
English: Gastrointestinal stromal tumour (GIST)
Maltese: Tumur ta' l-istroma gastrointestinali (GIST)
English: At the time of the prespecified interim analysis, the median TTP on sunitinib was 28.9 weeks (95% CI: 21.3, 34.1) as assessed by the investigator and 27.3 weeks (95% CI: 16.0, 32.1) as assessed by the independent review and was statistically significantly longer than the TTP on placebo of 5.1 weeks (95% CI: 4.4, 10.1) as assessed by the investigator and 6.4 weeks (95% CI: 4.4, 10.0) as assessed by the independent review.
Maltese: Waqt iż-żmien predeterminat ta' l-analiżi, it-TTP medjan fuq sunitinib kien 28.9 ġimgħat (95% CI: 21.3, 34.1) hekk kif kien assessjat mill-Investigatur u 27.3 ġimgħat (95% CI: 16.0, 32.1) u kien statistikament sinifikattiv itwal mit-TTP tal-plaċebo ta' 5.1 ġimgħat (95% CI: 4.4, 10.1) hekk kif kien assessjat mill-Investigatur u 6.4 ġimgħat (95% CI =
English: OS data were not mature at the time of the study closure [20.6 months (95% CI: 20.6, NR) for the sunitinib arm compared to NR (95% CI: 15.5, NR) for the placebo arm, hazard ratio: 0.409 (95% CI: 0.187, 0.894), p-value=0.0204].
Maltese: 5, NR) għallparti tal-istudju dwar il-plaċebo, proporzjon ta' periklu: 0.409 (95% CI: 0.187, 0.894), valur p = 0.0204].
English: Cases of proteinuria and rare cases of nephrotic syndrome have been reported.
Maltese: Kienu rrappurtati każijiet ta' proteinurja u każijiet rari tas-sindromu nefrotiku.
English: - Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide
Maltese: - Il-qoxra tal-kapsula: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide
English: The diagnosis of TMA, including thrombotic thrombocytopaenic purpura (TTP) and haemolytic uraemic syndrome (HUS), sometimes leading to renal failure or a fatal outcome, should be considered in the occurrence of haemolytic anaemia, thrombocytopenia, fatigue, fluctuating neurological manifestation, renal impairment, and fever.
Maltese: Id-dijanjosi ta' TMA, inkluż purpura tromboċitopenika trombotika (TTP, thrombotic thrombocytopaenic purpura) u sindrome uraemiku emolitiku (HUS, haemolytic uraemic syndrome), xi kultant twassal għal indeboliment renali jew għal riżultat fatali, għandha tiġi kkunsidrata fl-okkorrenza ta' anemija emolitika, tromboċitopenja, għeja, manifestazzjoni newroloġika varjabbli, indeboliment tal-kliewi u deni.
English: u Dermatitis psoriasiform, exfoliative rash, rash, rash erythematous, rash follicular, rash generalised, rash macular, rash maculo-papular, rash papular, and rash pruritic.
Maltese: Dermatite b'forma ta' psorjasi, raxx bil-qxur, raxx, raxx eritematiku, raxx follikulari, raxx ġeneralizzat, raxx makulari, raxx makulopapulari, raxx papulari, u raxx bil-ħakk.
English: The most common adverse reactions of any grade (experienced by patients in RCC, GIST, and pNET registrational trials) included decreased appetite, taste disturbance, hypertension, fatigue, gastrointestinal disorders (i.e. diarrhoea, nausea, stomatitis, dyspepsia, and vomiting), skin discolouration, and palmar-plantar erythrodysaesthesia syndrome.
Maltese: L-aktar reazzjonijiet avversi komuni (esperjenzati minn pazjenti fil-provi ta' reġistrazzjoni ta' RCC, GIST, u pNET) ta' kwalunkwé grad kienu jinkludu: tnaqqis fl-aptit, disturbi fit-togħma, pressjoni għolja, għejja, disturbi gastrointestinali, (i.e. dijarea, dardir, stomatité, dispepsja u remettar), tibdil fil-kulur tal-ġilda, u sindromu palmar-plantar erythrodysaesthesi.
English: The investigator-assessed median PFS was 13.2 months, both in the overall population (95% CI: 10.9, 16.7) and in the treatment-naïve cohort (95% CI: 7.4, 16.8).
Maltese: Il-PFS medjana globali kif kienet assessjata mill-Investigatur kienet ta' 13.2 xhur, kemm filpopolazzjoni ġenerali (95% CI: 10.9, 16.7) kif ukoll fil-koorti ta' pazjenti li qatt ma rċivew kura (95% CI: 7.4, 16.8).
English: At approximately twice therapeutic concentrations, the maximum QTcF interval change from baseline was 15.4 msec (90% CI: 22.4 msec).
Maltese: B'konċentrazzjonijiet kważi d-doppju ta' dawk terapewtiċi, il-bidla massima fl-intervall QTcF mil-linja bażi kienet ta' 15.4 msec (90% CI 22.4 msec).
English: The overall PFS and OS, observed in the ITT population, as determined by the core radiology laboratory assessment, are summarised in Table 3.
Maltese: Il-PFS u OS totali fil-popolazzjoni ITT, kif determinata bil-valutazzjoni tal-laboraturju radjoloġiku ċentrali, qeda mqassra f'Tabella 3:
English: The median PFS was 11.4 months for the sunitinib arm compared to 5.5 months for the placebo arm [hazard ratio: 0.418 (95% CI: 0.263, 0.662), p-value=0.0001]; similar results were observed when derived tumour response assessments based upon application of RECIST to investigator tumour measurements were used to determine disease progression, as shown in Table 4.
Maltese: Il-PFS medjana kienet 11.4-il xahar għall-grupp li ngħata sunitinib meta pparagunata ma' 5.5 xhur għall-grupp li ħa plaċebo [proporzjon tal-periklu: 0.418 (95% CI: 0.263, 0.662), valur p = 0.0001]; ġew osservati riżultati simili meta ntużaw stimi derivati tar-rispons tat-tumur ibbażati fuq l-applikazzjoni ta' RECIST għall-kejl tat-tumur mill-investigatur sabiex tiġi determinata l-progressjoni tal-marda, kif jidher f'Tabella 5.
English: The other ingredients are: - Capsule content: mannitol, croscarmellose sodium, povidone (K-25), and magnesium stearate.
Maltese: - Il-kontenut tal-kapsula: mannitol, croscarmellose sodium, povidone (K-25) u magnesium stearate.
English: The most frequent adverse drug reactions were diarrhoea, nausea, WBC count decreased, neutropenia, and headache in 3 (50.0%) patients each, primarily Grade 1 or 2 in severity.
Maltese: L-aktar reazzjonijiet avversi tal-mediċina frekwenti kienu dijarea, dardir, tnaqqis fl-għadd tal-WBC (white blood cells), newtropenja, u uġigħ ta' ras fi 3 (50.0%) pazjenti kull wieħed, primarjament ta' Grad 1 jew 2 fis-severità.
English: • Abnormal muscle breakdown which can lead to kidney problems (rhabdomyolysis).
Maltese: • Kollass mhux normali tal-muskoli li jista' jwassal għal problemi fil-kliewi (rabdomijolisi).
English: Temporary suspension of sunitinib is recommended; following resolution, treatment may be resumed at the discretion of the treating physician (see section 4.8).
Maltese: Sospensjoni temporanja ta' sunitinib hija rakkomandata: it-trattament jista' jitkompla fid-diskrezzjoni tat-tabib kuranti (ara sezzjoni 4.8).
English: Reversal of the effects of TMA has been observed after treatment discontinuation (see section 4.8).
Maltese: It-treġġigħ lura tal-effetti tat-TMA ġie osservat wara t-twaqqif tattrattament (ara sezzjoni 4.8).
English: The most common (≥10%) reported treatment-related adverse events in patients in both groups combined were neutrophil count decreased (6 patients [20.7%]) and haemorrhage intracranial (3 patients [10.3%]) (see section 4.8).
Maltese: L-aktar reazzjonijiet avversi relatati mal-kura li ġew irrappurtati b'mod komuni (≥10%) fil-pazjenti fiż-żewġ gruppi kombinati kienu tnaqqis fl-għadd tan-newtrofili (6 pazjenti [20.7%]) u emorraġija intrakranjali (3 pazjenti [10.3%]) (ara sezzjoni 4.8).
English: Metastatic renal cell carcinoma (MRCC) Sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults.
Maltese: Karċinoma metastatika taċ-ċellola renali (MRCC) Sutent huwa ndikat għat-trattament ta' karċinoma taċ-ċellola renali (MRCC) metastatika/avvanzata f'persuni adulti
English: Co-administration of sunitinib with potent CYP3A4 inducers, such as rifampicin, should be avoided (see sections 4.4 and 4.5).
Maltese: Ko-amministrazzjoni ta' sunitinib ma' induċituri qawwija ta' CYP3A4 bħal ma huma rifampin, għandha tiġi evitata (ara sezzjonijiet 4.4 u 4.5).
English: - Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172).
Maltese: - Il-qoxra tal-kapsula: gelatin, titanium dioxide (E171), yellow iron oxide (E172).
English: In these paediatric patients without previous exposure to anthracyclines or cardiac irradiation, the maximum tolerated dose (MTD) has been identified (see section 5.1).
Maltese: F'dawn il-pazjenti pedjartiċi mingħajr esponiment minn qabel għal anthracyclines jew irradjazzjoni kardijaka, ġiet identifikata ddoża massima tollerata (MTD, maximum tolerated dose) (ara sezzjoni 5.1).
English: One hundred and 6 patients received at least one 50 mg dose of sunitinib on Schedule 4/2.
Maltese: Mija u 6 pazjenti ngħataw ta' l-anqas doża waħda ta' 50 mg ta' sunitinib fuq Skeda 4/2.
English: Patients with signs or symptoms of muscle toxicity should be managed as per standard medical practice (see section 4.4).
Maltese: Pazjenti li juru sinjali jew sintomi ta' tossiċità muskolari għandhom jiġu ttrattati skont il-prattika medika standard (ara sezzjoni 4.4).
English: In a Phase 2 study in cytokine-refractory MRCC patients, 0.9% of patients experienced treatment-related fatal myocardial infarction and in the Phase 3 study in treatment-naïve MRCC patients, 0.6% of patients on the IFN- arm and 0% of patients on the sunitinib arm experienced fatal cardiac events.
Maltese: Fi studju ta' Fażi 2 ta' pazjenti b'MRCC refrattarja għaċ-ċitokini, 0.9% tal-pazjenti esperjenzaw infart mijokardijaku fatali relatat mal-kura u fil-Fażi 3 tal-istudju f'pazjenti b'MRCC li qatt ma kienu trattati qabel, 0.6% talpazjenti fit-taqsima ta' IFN- u 0% tal-pazjenti fit-taqsima tas-sunitinib esperjenzaw attakki tal-qalb fatali.
English: The median duration of treatment was 11.1 months (range: 0.4-46.1) for sunitinib treatment and 4.1 months (range: 0.1-45.6) for IFN-α treatment.
Maltese: Iż-żmien medju tat-trattament b'sunitinib kien ta' 11.1 xhur (medda ta': 04-46.1) u 4.1 xhur (medda ta': 0.1 - 45.6) għal trattament b' IFN-.
English: Sutent 12.5 mg hard capsules sunitinib
Maltese: Sutent 12.5 mg kapsuli ibsin sunitinib
English: Currently available data are described in sections 4.8, 5.1, and 5.2 but no recommendation on a posology can be made.
Maltese: Bħalissa d-dejta disponibbli hi deskritta f'sezzjonijiet 4.8. 5.1 u 5.2 imma l-ebda rakkomandazzjoni dwar il-pożoloġija ma tista' tingħata.
English: In clinical trials, decreases in left ventricular ejection fraction (LVEF) of  20% and below the lower limit of normal were reported in approximately 2% of sunitinib-treated GIST patients, 4% of cytokine-refractory MRCC patients, and 2% of placebo-treated GIST patients.
Maltese: Fi provi kliniċi, seħħ tnaqqis fil-porzjon imbuttat 'il barra mill-ventrikulu tan-naħa tax-xellug (LVEF) ta'  20% jew taħt il-limitu t'isfel tan-normal f'madwar 2% ta' pazjenti GIST ittrattati b'sunitinib, 4% ta' pazjenti MRCC refrattarja għaċ-ċitokini, u 2% tal-pazjenti GIST ittrattati bi plaċebo.
English: In the Phase 3 pNET study hypothyroidism was reported in 6 patients (7.2%) receiving sunitinib and in 1 patient (1.2%) on placebo.
Maltese: Fl-istudju pNET ta' Fażi 3, ipotirodjiżmu ġie rrappurtat f'6 pazjenti (7.2%) li rċevew sunitinib u f'pazjent 1 (1.2%) li ħa plaċebo.
English: Secondary PFS (weeks)
Maltese: Sekondarju PFS (ġimgħat)
English: At therapeutic plasma concentrations, the maximum QTcF interval (Frederica's correction) mean change from baseline was 9 msec (90% CI: 15.1 msec).
Maltese: B'konċentrazzjonijiet terapewtiċi fil-plasma, il-bidla medja massima fl-intervall QTcF (korrezzjoni ta' Frederica) mil-linja bażi kienet ta' 9.6 msec (90% CI 15.
English: m Acute myocardial infarction, myocardial infarction, and silent myocardial infarction.
Maltese: Infart mijokardijaku akut, infart mijokardijaku, infart mijokardijaku silenzjuż.
English: A 6-month, oral gavage carcinogenicity study (0, 8, 25, 75 [reduced to 50] mg/kg/day), with daily dosing was conducted in rasH2 transgenic mice.
Maltese: Sar studju dwar il-karċinoġeniċità fuq tul ta' 6 xhur, fejn ingħataw dożi kuljum permezz ta' pajp minn ġol-ħalq (0, 8, 25, 75 [mnaqqsa għal 50] mg/kg/kuljum) fi ġrieden transġeniċi rasH2.
English: Sunitinib was not clastogenic in rat bone marrow in vivo.
Maltese: Sunitinib ma kienx klastoġeniku fil-mudullun tal-far in vivo.
English: Severe cutaneous reactions have been reported, including cases of erythema multiforme (EM), cases suggestive of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some of which were fatal.
Maltese: Reazzjonijiet severi taħt il-ġilda, inkluż każijiet ta' eritema multiformi (EM), każijiet li jissuġġerixxu is-sindromu ta' Stevens-Johnson (SJS) u nekroliżi epidermali tossika (TEN), kienu rrapurtati, u xi wħud minnhom kienu fatali.
English: Seventeen (4.5%) patients on sunitinib versus 5 (1.7%) patients on IFN-α experienced Grade 3 or greater bleeding events.
Maltese: Sbatax (45%)-il pazjent fuq sunitinib kontra 5 (1.7%) pazjenti fuq IFN-α esperjenzaw reazzjonijiet emorraġiċi ta' Grad 3 jew aktar.
English: In this study, the median TTP was 34.0 weeks (95% CI: 22.0, 46.0).
Maltese: F'dan l-istudju iż-Żmien sal-TTP medjan kien ta' 34.0 ġimgħat (95% CI: 22.0, 46.0).
English: A population pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/PD) analysis was conducted with the scope to extrapolate the PK and key safety and efficacy endpoints of sunitinib in paediatric patients with GIST (aged: 6 years to 17 years).
Maltese: Analiżi tal-farmakokinetika tal-popolazzjoni (PK) u farmakodinamika farmakokinetika (PK/PD) saret bl-iskop li jiġu estrapolati l-punti ta' tmiem ewlenin ta' effikaċja u sigurtà u tal-PK ta' sunitinib f'pazjenti pedjatriċi b'GIST (li għandhom bejn 6-17-il sena).
English: Unstratified analysis Hazard ratio (sunitinib versus IFN-) 95% CI for hazard ratio p-value a
Maltese: Analażi mhux stratifikata Proporzjon ta' riskju (sunitinib versus IFN-) 95% CI għal proporzjon ta' riskju Valur p a
English: All findings occurred at clinically relevant sunitinib plasma exposure levels.
Maltese: Is-sejbiet kollha seħħew fl-livelli klinikament relevanti ta' esponiment fil-plażma ta' sunitinib.
English: Pyoderma gangrenosum Toxic epidermal necrolysis*
Maltese: StevensJohnson Pyoderma gangrenos um (kankrena tal-ġilda) Nekroliżi epidermali tossika
English: Systemic exposures after a single dose of sunitinib were similar in subjects with mild or moderate (Child-Pugh Class A and B) hepatic impairment compared to subjects with normal hepatic function.
Maltese: Esponimenti sistemiċi wara doża waħda ta' sunitinib kienu simili f'suġġetti b'indeboliment tal-fwied ħafif jew moderat (Klassi Child-Pugh A u B) imqabbla ma' suġġetti b'funzjoni epatika normali.
English: Severe hypertension was reported in 10% of pNET patients on sunitinib and 3% of patients on placebo.
Maltese: Pressjoni għolja severa seħħet f'10% tal-pazjenti pNET fuq sunitinib u fi 3% tal-pazjenti fuq plaċebo.
English: Serious, sometimes fatal gastrointestinal complications including gastrointestinal perforation were reported in patients with intra-abdominal malignancies treated with sunitinib.
Maltese: Kumplikazzjonijiet gastrointestinali serji, xi daqqiet fatali, inklużi perforazzjoni gastrointestinali ġew irrapportati f'pazjenti b'malinnijiet intra-addominali ttrattati b'sunitinib.
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 HGG or ependymoma.
Maltese: 2 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) b'HGG jew ependimoma.
English: Sunitinib (0.3, 1.0, 3.0 mg/kg/day) was evaluated in a pre-and postnatal development study in pregnant rats.
Maltese: Sunitinib (f'doża ta' 0.3, 1.0, 3.0 mg/kg/kuljum) kien evalwat fi studju dwar l-iżvilupp ta' qabel u wara t-twelid fuq firien tqal.
English: • Inflammation of the thyroid gland.
Maltese: • Infjammazzjoni tal-glandola tat-tirojde.
English: Diarrhoea, nausea/vomiting, abdominal pain, dyspepsia, and stomatitis/oral pain were the most commonly reported gastrointestinal adverse reactions; oesophagitis events have been also reported (see section 4.8).
Maltese: Dijarea, dardir/rimettar, uġigħ addominali, dispepsija u stomatite/uġigħ fil-ħalq kienu l-aktar reazzjonijiet avversi gastrointestinali rrappurtati b'mod komuni; avvenimenti ta' esofaġite kienu rrapurtati wkoll (ara sezzjoni 4.8).
English: Dyspnoea Epistaxis Cough
Maltese: Emorraġija ċerebrali
English: Rhabdomyolysis* Myopathy
Maltese: TWISSIJA(IET) SPEĊJALI
English: Sutent 37.5 mg hard capsules
Maltese: Sutent 37.5 mg kapsuli ibsin
English: Sutent 37.5 mg hard capsules EU/1/06/347/007
Maltese: Sutent 37.5 mg kapsuli ibsin EU/1/06/347/007
English: BLISTER - 50 MG CAPSULES
Maltese: FOLJA- 50MG KAPSULI
English: Sunitinib did not induce structural chromosome aberrations in human peripheral blood lymphocyte cells in vitro.
Maltese: Sunitinib in vitro ma induċiex aberazzjonijiet strutturali fil-kromożomi taċ-ċelloli limfoċiti fid-demm periferali uman.
English: - Capsule shell: gelatin, red iron oxide (E172), and titanium dioxide (E171).
Maltese: - Il-qoxra tal-kapsula: gelatin, red iron oxide (E172) u titanium dioxide (E171).
English: You may require medical attention.
Maltese: Tista' teħtieġ attenzjoni medika.
English: Venous thromboembolic events
Maltese: Reazzjonijiet tromboemboliċi venużi
English: 37.5 mg hard capsules Each capsule contains sunitinib malate, equivalent to 37.5 mg of sunitinib.
Maltese: 37.5 mg kapsuli ibsin Kull kapsula fiha sunitinib malate, ekwivalenti għal 37.5 mg ta' sunitinib.
English: Thyroid dysfunction
Maltese: Disfunzjoni tat-tirojde
English: Fisher's Exact test
Maltese: Test eżatt ta' Fisher
English: Changes in sunitinib PK parameters were of no clinical significance and did not indicate any drug-drug interactions; however, considering the relatively low number of subjects (i.e. N=7+4) and the moderate-large interpatient variability in the pharmacokinetic parameters, caution needs to be taken when interpreting the PK drug-drug interaction findings from this study.
Maltese: It-tibdil fil-parametri tal-PK ta' sunitinib ma kien ta' l-ebda sinifikat kliniku u ma indika l-ebda interazzjoni mediċinali; madankollu, meta jiġi kkunsidrat in-numru relattivament baxx ta' individwi (jiġifieri N=7+4) u l-varjabbiltà moderata-kbira bejn pazjent u ieħor fil-parametri farmakokinetiċi, għandha tingħata l-kawtela meta jiġu interpretati s-sejbiet tal-PK tal-interazzjoni mediċinali minn dan l-istudju.
English: In the other study hypothyroidism was reported in a total of 31 (13%) patients on sunitinib and 2 (0.8%) patients on capecitabine.
Maltese: Fl-istudju l-ieħor, ipotirojdiżmu ġie rrappurtat f'total ta' 31 (13%) pazjent b'sunitinib u f'2 pazjenti (0.8%) b'capecitabine.
English: Stable disease was observed in 6 patients (17%).
Maltese: Marda stabbli kienet osservata f'6 pazjenti (17%).
English: Gastro-oesophageal reflux disease Dysphagia Gastrointestinal haemorrhage* Oesophagitis*
Maltese: Mard ta' rifluss gastro-esofagali Disfaġja
English: Sutent 12.5 mg hard capsules
Maltese: Sutent 12.5 mg kapsuli ibsin
English: Overall survival [5 years follow-up] [median, months (95% CI)]
Maltese: [5 snin ta' segwitu] [medja, xhur (95% CI)]
English: Fatal events other than those listed in section 4.4 above or in section 4.8 below that were considered possibly related to sunitinib included multi-system organ failure, disseminated intravascular coagulation, peritoneal haemorrhage, adrenal insufficiency, pneumothorax, shock, and sudden death.
Maltese: Ġrajjiet fatali barra minn dawk imniżżla f'sezzjoni 4.4 hawn fuq jew fis-sezzjoni 4.8 hawn isfel li kienu kkunsidrati bħala possibbilment relatati ma' sunitinib kienu jinkludu: insuffiċjenza ta' organi varji, koagulazzjoni intravaskulari mxerrda, emorraġija peritoneali, insuffiċjenza adrenali, pnewmotoraċi, xokk u mewt zopptu.