FrancophonIA/ELRC3.0 huggingface dataset:
English: Seven patients (3%) on sunitinib and none on placebo in a Phase 3 GIST study experienced venous thromboembolic events; 5 of the 7 were Grade 3 deep venous thrombosis (DVT) and 2 were Grade 1 or 2.
Maltese: Fi studju GIST Fażi 3, seba' pazjenti (3%) fuq sunitinib u l-ebda pazjent fuq plaċebo esperjenzaw reazzjonijiet tromboemboliċi venużi; 5 mis-7 kienu trombożi tal-vini l-fondi (DVT) ta' Grad 3, u 2 kienu ta' Grad 1 jew 2.
English: The primary efficacy endpoint of the study was TTP, defined as the time from randomisation to first documentation of objective tumour progression.
Maltese: Il-punt ta' tmiem ta' l-effikaċja primarja ta' listudju kien TTP, mfisser bħala ż-żmien mir-randomizzazzjoni sa l-ewwel dokumentazzjoni ta' progressjoni tat-tumur oġġettiva.
English: Sutent 12.5 mg hard capsules EU/1/06/347/001
Maltese: Sutent 12.5 mg kapsuli ibsin EU/1/06/347/001 ΕU/1//06/347/004
English: Studies in cancer patients have excluded patients with ALT or AST > 2.5 x ULN (upper limit of normal) or > 5.0 x ULN if due to liver metastasis.
Maltese: Studji f'pazjenti bil-kanċer eskludew pazjenti b'ALT jew AST >2.5 x ULN (Limitu ta' Fuq tanNormal) jew, >5.0
English: Musculoskeletal pain Muscle spasms Myalgia
Maltese: Uġigħ muskoluskeletrali
English: This study was a multi-centre, open-label, Phase 1/2 study examining the safety/tolerability, the maximum tolerated dose, and the antitumour activity of sunitinib in combination with gefitinib in subjects with MRCC.
Maltese: Dan l-istudju multiċentriku, open-label, ta' Fażi 1/2 li eżamina s-sigurtà/it-tollerabbiltà, id-doża massima ttollerata, u l-attività kontra t-tumur ta' sunitinib flimkien ma' gefitinib f'individwi b'MRCC.
English: Haematological disorders (e.g., neutropenia, thrombocytopenia, and anaemia) are amongst the most common adverse drug reactions.
Maltese: Disturbi ematoloġiċi (eż. newtropenja, tromboċitopenja, u anemija) huma fost l-aktar reazzjonijiet komuni avversi tal-mediċina.
English: Skin hyperpigmentation Skin lesion Hyperkeratosis Dermatitis Nail disorderw
Maltese: Uġigħ fl-estremità Artralġja Uġigħ fid-dahar
English: Sutent 25 mg hard capsules
Maltese: Sutent 25 mg kapsuli ibsin
English: Co-administration with potent CYP3A4 inducers should be avoided because it may decrease sunitinib plasma concentration (see sections 4.2 and 4.5).
Maltese: Ko-amministrazzjoni ma' impedituri qawwija ta' CYP3A4 għandha tiġi evitata minħabba li tista' żżid il-konċentrazzjoni ta' sunitinib fil-plażma (ara sezzjonijiet 4.2 u 4.5).
English: Gastroduodenal carcinomas, an increased incidence of background haemangiosarcomas, and/or gastric mucosal hyperplasia were observed at doses of ≥ 25 mg/kg/day following 1- or 6-months duration (≥ 7.3 times the AUC in patients administered the recommended daily dose RDD).
Maltese: Karċinomi gastro-duwodenali, inċidenza akbar ta' haemangiosarcomas fl-isfond, u/jew iperplasija tal-mukuża gastrika kienu osservati f'dożi ta' ≥25 mg/kg/kuljum wara trattament ta' xahar jew sitt xhur (≥7.3 darbiet tal-AUC tal-pazjenti li ngħataw id-doża rakkomandata ta' kuljum [RDD]).
English: Sunitinib has not been studied in subjects with severe (Child-Pugh class C) hepatic impairment and therefore its use in patients with severe hepatic impairment cannot be recommended (see section 5.2).
Maltese: Sunitinib ma ġiex studjat f'suġġetti b'indeboliment epatiku sever (Child-Pugh klassi C) u għalhekk l-użu tiegħu f'pazjenti b'indeboliment epatiku sever ma jistax jkun rakkomandat (ara sezzjoni 5.2).
English: Gastrointestinal perforationq,* Pancreatitis Anal fistula Colitisr
Maltese: Pankreatite Fistla anali Koliter
English: Sunitinib and its primary metabolite are mainly metabolised by the liver.
Maltese: Sunitinib u l-metabolit primarju tiegħu huma prinċipalment metabolizzati mill-fwied.
English: • Changes in the electrical activity or abnormal rhythm of the heart.
Maltese: • Tibdil fl-attività elettrika tal-qalb jew ritmu mhux normali tal-qalb.
English: Sutent 25 mg is supplied as hard gelatin capsules with caramel cap and orange body, printed with white ink “Pfizer” on the cap, “STN 25 mg” on the body, containing yellow to orange granules.
Maltese: Sutent 25 mg jiġi bħala kapsuli ibsin tal-ġelatina b'għatu kulur il-karamella u parti ewlenija oranġjo, bil-kelma “Pfizer” miktuba b'linka bajda fuq l-għatu, u “STN 25mg” fuq il-parti ewlenija, li fihom granijiet sofor għal oranġjo.
English: Most of these findings were reversible after 2 to 6 weeks without treatment.
Maltese: 2 sa 6 ġimgħat mingħajr trattament.
English: Each capsule contains sunitinib malate equivalent to 12.5 mg sunitinib.
Maltese: Kull kapsula fiha sunitinib malate, ekwivalenti għal 12.5mg ta' sunitinib.
English: In patients who have previously received or are receiving intravenous bisphosphonates, invasive dental procedures should be avoided if possible (see section 4.8).
Maltese: F'pazjenti li jkunu ħadu jew qed jieħdu bisphosphonates li jittieħdu ġol-vina, jekk possibbli proċeduri dentali invażivi għandhom jiġu evitati (ara sezzjoni 4.8).
English: Population PK analyses of demographic data indicate that no starting dose adjustments are necessary for weight or Eastern Cooperative Oncology Group (ECOG) performance status.
Maltese: Analiżi tal-PK fost il-popolazzjoni ta' informazzjoni demografika tindika li m'hemmx bżonn ta' aġġustamenti fid-doża għall-piż jew għall-istatus tal-prestazzjoni tal-Grupp ta' Kooperazzjoni talLvant dwar l-Onkoloġija (ECOG).
English: Oedemay
Maltese: Fawra
English: Cardiovascular events, including heart failure, cardiomyopathy, left ventricular ejection fraction decline to below the lower limit of normal, myocarditis, myocardial ischaemia and myocardial infarction, some of which were fatal, have been reported in patients treated with sunitinib.
Maltese: Episodji kardjovaskulari, li jinkludu falliment kardijaku, kardjomijopatija, porzjon imbuttat 'il barra mill-ventrikulu tan-naħa tax-xellug (LVEF, left ventricular ejection fraction) taħt il-limitu t'isfel tannormal, mijokardite, iskemija mijokardijaka u infart mijokardijaku, li wħud minnhom kienu fatali, ġew rrappurtati f'pazjenti trattati b'sunitinib.
English: Medicinal products that may increase sunitinib plasma concentrations Effect of CYP3A4 inhibitors
Maltese: L-amministrazzjoni ta' sunitinib ma' impedituri potenti ta' CYP3A4
English: The long-term safety of sunitinib in patients with MRCC was analysed across 9 completed clinical studies conducted in the first-line, bevacizumab-refractory, and cytokine-refractory treatment settings in 5,739 patients, of whom 807 (14%) were treated for ≥ 2 years up to 6 years.
Maltese: Is-sigurtà fit-tul ta' sunitinib f'pazjenti b'MRCC ġiet analizzata f'9 studji kliniċi mitmuma li saru flambjenti ta' kura tal-ewwel linja, b'MRCC refrattarja għal bevacizumab u refrattarja għaċ-ċitokini, f'5,739 pazjent li minnhom, 807 (14 %) ġew ikkurati għal ≥sentejn sa 6 snin.
English: If this is not possible, the dose of Sutent may need to be increased in 12.5 mg increments (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 (see section 4.2).
Maltese: Jekk dan mhuwiex possibbli, id-doża ta' Sutent jista' jkollha bżonn tiġi miżjuda b'inkrimenti ta' 12.5 mg (sa 87.5 mg kuljum għal GIST u MRCC jew 62.5 mg kuljum għal pNET) ibbażat fuq sorveljanza bir-reqqa tat-tolerabbilità (ara sezzjoni 4.2).
English: In the dosing ranges of 25 to 100 mg, the area under the plasma concentration-time curve (AUC) and Cmax increase proportionally with dose.
Maltese: Fil-medda ta' dożi bejn 25 u 100 mg, l-arja taħt il-kurva tal-konċentrazzjoni fil-plażma mal-ħin (AUC) u l-Cmax jiżdiedu b'mod proporzjonali mad-doża.
English: This event is generally reversible after sunitinib discontinuation.
Maltese: Dan l-avveniment huwa ġeneralment riversibbli wara li jitwaqqaf sunitinib.
English: 25 mg hard capsules Each capsule contains sunitinib malate, equivalent to 25 mg of sunitinib.
Maltese: 25 mg kapsuli ibsin Kull kapsula fiha sunitinib malate, ekwivalenti għal 25 mg ta' sunitinib.
English: 37.5 mg hard capsules Capsule content Mannitol (E421) Croscarmellose sodium Povidone (K-25) Magnesium stearate
Maltese: 37.5 mg kapsuli ibsin Kontenut tal-kapsula Mannitol (E421) Croscarmellose sodium Povidone (K-25) Magnesium stearate
English: Hyperthyroidism was reported in 4 (1.7%) patients on sunitinib and no patients on capecitabine.
Maltese: Ipertirojdiżmu ġie rrappurtat f'4 (1.7%) pazjenti b'sunitinib u fl-ebda pazjent b'capecitabine.
English: The EMA has waived the obligation to submit the results of the studies with Sutent in all subsets of the paediatric population for the treatment of gastroenteropancreatic neuroendocrine tumours (excluding neuroblastoma, neuroganglioblastoma, and phaeochromocytoma) (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 tat-tumuri newroendokrinali gastroenteropankreatiċi (esklużi newroblastoma, newroganglioblastoma u phaeochromocytoma) (ara sezzjoni 4.2)
English: • Mouth pain/irritation, mouth sores/inflammation/dryness, taste disturbances, upset stomach,
Maltese: • Uġigħ /irritazzjoni/nixfa fil-ħalq, ġrieħi fil-ħalq, disturbi tat-togħma, stonku mħawwad, dardir,
English: Supportive care for gastrointestinal adverse reactions requiring treatment may include medicinal products with antiemetic, antidiarrhoeal, or antacid properties.
Maltese: Il-kura ta' appoġġ għar-reazzjonijiet avversi gastrointestinali li jeħtieġu trattament tista' tinkludi prodotti mediċinali bi proprjetajiet anti-emetiċi,,kontra d-dijarea jew kontra l-aċtu.
English: The primary metabolite exhibits similar potency compared to sunitinib in biochemical and cellular assays.
Maltese: F'assaġġi bijokemikali u ċellulari il-metabolit primarju jesibixxi potenza simili komparat ma'sunitinib.
English: During sunitinib treatment, routine monitoring of thyroid function should be performed every 3 months.
Maltese: Waqt it-trattament b'sunitinib, huwa meħtieġ li jsir monitoraġġ regolari tal-funzjoni tat-tirojde kull 3 xhur.
English: Hyperthyroidism Thyroiditis
Maltese: Inċident ċerebrovaskulari
English: • Chills.
Maltese: • Puplesija.
English: Sutent can cause heart problems.
Maltese: Sutent jista' jikkawża problemi fil-qalb.
English: Progression-free survival [median, months (95% CI)] by derived tumour response assessment based upon application of RECIST to investigator tumour assessments
Maltese: Sopravivenza mingħajr Progressjoni [medja, xhur (95% CI)] b'Valutazzjoni mill-Investigatur Sopravivenza mingħajr Progressjoni [medja, xhur (95% CI)] b'valutazzjoni derivata tar-rispons tat-tumur ibbażata fuq l-applikazzjoni ta' RECIST għall-valutazzjonijiet tattumur mill-investigatur Sopravivenza mingħajr Progressjoni [medja, xhur (95% CI)] b'eżami ċentrali indipendenti blinded talvaluazzjonijiet tat-tumur Sopravivenza globali
English: Cytokine-refractory metastatic renal cell carcinoma A Phase 2 study of sunitinib was conducted in patients who were refractory to prior cytokine therapy with interleukin-2 or IFN-.
Maltese: Pazjenti li kellhom emboliżmu pulmonari fi żmien it-12-il xahar preċedenti ġew esklużi minn studji kliniċi b'sunitinib.
English: Mucosal inflammation Fatiguex
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi
English: In case of symptomatic hypoglycaemia, sunitinib should be temporarily interrupted.
Maltese: Fil-każ ta' ipogliċemija sintomatika, sunitinib għandu jitwaqqaf temporanjament.
English: Overall, 7% of the MRCC population had either clinical or laboratory evidence of treatment-emergent hypothyroidism.
Maltese: Kollox ma' kollox, 7% tal-popolazzjoni MRCC kellha evidenza jew klinika jew tal-laboratorju ta' ipotirojdiżmu li ħareġ bit-trattament.
English: Sunitinib was not mutagenic in bacteria using metabolic activation provided by rat liver.
Maltese: Sunitinib ma kienx mutaġeniku fil-batterji bl-użu ta' attivazzjoni metabolika fornita mill-fwied tal-far.
English: Sutent 50 mg is supplied as hard gelatin capsules with caramel cap and caramel body, printed with white ink “Pfizer” on the cap, “STN 50 mg” on the body, containing yellow to orange granules.
Maltese: Sutent 50 mg jiġi bħala kapsuli ibsin tal-ġelatina b'għatu kulur il-karamella u parti ewlenija oranġjo, bil-kelma “Pfizer” miktuba b'linka bajda fuq l-għatu, u “STN 50mg” fuq il-parti ewlenija, li fihom granijiet sofor għal oranġjo.
English: Pancreatitis has been observed uncommonly (< 1%) in patients receiving sunitinib for GIST or MRCC. No treatment-related pancreatitis was reported in the Phase 3 pNET study (see section 4.4).
Maltese: Madankollu, ħafna minn dawn l-avvenimenti avversi osservati fi studji kliniċi ma kinux ikkunsidrati bħala relatati mat-trattament tal-istudju (ara sezzjoni 4.4).
English: One hundred six patients (61 patients in the treatment-naïve cohort and 45 patients in the later-line cohort) received treatment with sunitinib orally at 37.5 mg once a day on a continuous daily dosing (CDD) schedule.
Maltese: Mija u sitt pazjenti (61 pazjent fil-grupp ta' dawk li qatt ma kienu ħadu kura qabel bħalu u 45 pazjent fil-grupp tal-linja aktar tard) irċivew kura b'sunitinib b'mod orali ta' 37.5 mg darba kuljum fuq skeda ta' dożaġġ kontinwu kuljum (CDD, continuous daily dosing).
English: Decreased absolute neutrophil counts and decreased platelet counts were reported in association with sunitinib (see section 4.8).
Maltese: Tnaqqis fl-għadd assolut tan-newtrofili u għadd imnaqqas ta' plejtlits ġew irrapportati f'assoċjazzjoni ma' sunitinib (ara sezzjoni 4.8).
English: In clinical trials, tumour haemorrhage was reported in approximately 2% of patients with GIST.
Maltese: Fil-provi kliniċi, ġiet irrapportat emorraġija tat-tumur f'madwar 2% tal-pazjenti b'GIST.
English: Polyploidy (numerical chromosome aberrations) was observed in human peripheral blood lymphocytes in vitro, both in the presence and absence of metabolic activation.
Maltese: In vitro, poliplojdi (aberazzjonijiet numeriċi tal-kromożomi) kienet osservata fil-limfoċiti fid-demm periferali uman, kemm fil-preżenza u fin-nuqqas ta' attivazzjoni metabolika.
English: If signs or symptoms of hepatic failure are present, sunitinib should be discontinued and appropriate supportive care should be provided (see section 4.8).
Maltese: Jekk ikun hemm sintomi ta' insuffiċjenza tal-fwied, sunitinib għandu jiġi mwaqqaf u tingħata kura xierqa ta' sostenn (ara sezzjoni 4.8).
English: Tumour haemorrhage*
Maltese: Emorraġija minn tumur
English: Each capsule contains sunitinib malate, equivalent to 25 mg of sunitinib.
Maltese: Kull kapsula fiha sunitinib malate, ekwivalenti għal 25 mg ta' sunitinib.
English: 25 mg hard capsules Capsule content Mannitol (E421) Croscarmellose sodium Povidone (K-25) Magnesium stearate
Maltese: 25 mg kapsuli ibsin Kontenut tal-kapsula Mannitol (E421) Croscarmellose sodium Povidone (K-25) Magnesium Stearate
English: Pulmonary haemorrhage* Respiratory failure*
Maltese: Emorraġija filpulmun Insuffiċjenza respiratorja
English: 50 mg hard capsules Capsule content Mannitol (E421) Croscarmellose sodium Povidone (K-25) Magnesium stearate
Maltese: 50 mg kapsuli ibsin Kontenut tal-kapsula Mannitol (E421) Croscarmellose sodium Povidone (K-25) Magnesium stearate
English: Demographics were comparable between the sunitinib and placebo groups.
Maltese: Id-demografiċi kienu komparabbli bejn il-gruppi li ħadu sunitinib u dawk li ħadu plaċebo.
English: Torsade de pointes
Maltese: Punt ta' Tmiem Sutent
English: A total of 255 patients received sunitinib in the open-label treatment phase of the study, including 99 patients who were initially treated with placebo.
Maltese: Fil-fażi ta' trattament b'tikketta open-label, inklużi 99 pazjent li kienu inizjalment ttrattati bi plaċebo, total ta' 225 pazjenti rċevew sunitinib.
English: Hypertension was reported in approximately 33.9% of patients receiving sunitinib for treatment-naïve MRCC compared to 3.6% of patients receiving IFN-.
Maltese: Pressjoni għolja kienet irrappurtata f'bejn wieħed u ieħor 33.9% talpazjenti li kienu jirċievu sunitinib għall-kura ta' MRCC, li qatt ma kienet trattata qabel, imqabbla ma' 3.6% ta' pazjenti li jirċievu IFN-.
English: Deep vein thrombosis Hot flush
Maltese: Mard jixbah linfluwenza Tertir
English: Hypothyroidism has been observed to occur early as well as late during treatment with sunitinib (see section 4.8).
Maltese: Ipotirojdiżmu kien osservat li jseħħ kmieni kif ukoll tard waqt it-trattament b'sunitinib (ara sezzjoni 4.8).
English: Gelatin capsules with caramel cap and orange body, printed with white ink “Pfizer” on the cap, “STN 25 mg” on the body, and containing yellow to orange granules.
Maltese: Kapsuli tal-ġelatina b'għatu kulur il-karamella u bil-parti ewlenija oranġjo, bil-kelma “Pfizer” stampata b'inka bajda fuq l-għatu, “STN 25 mg” fuq il-parti ewlenija, u li fihom granijiet safrani għal oranġjo.
English: Sutent is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) with disease progression in adults.
Maltese: Sutent huwa indikat għat-trattament ta' tumuri newroendokrinali fil-frixa (pNET) li ma jistgħux jitneħħew jew metastatiċi, differenzjati sewwa, bi progressjoni tal-marda f'persuni adulti.
English: 12.5 mg hard capsules Capsule content Mannitol (E421) Croscarmellose sodium Povidone (K-25) Magnesium stearate
Maltese: 12.5mg kapsuli ibsin Kontenut tal-kapsula Mannitol (E421) Croscarmellose Sodium Povidone (K-25) Magnesium Stearate
English: 50 mg hard capsules Each capsule contains sunitinib malate, equivalent to 50 mg of sunitinib.
Maltese: 50 mg kapsuli ibsin Kull kapsula fiha sunitinib malate, ekwivalenti għal 50 mg ta' sunitinib.
English: The results of this study demonstrated that sunitinib had an effect on QTc interval (defined as a mean placebo-adjusted change of > 10 msec with a 90% confidence interval [CI] upper limit > 15 msec) at therapeutic concentration (Day 3) using the within-day baseline correction method,
Maltese: Ir-riżultati ta' dan l-istudju wrew li sunitinib kellu effett fuq il-QTc (definita bħala bidla medja aġġustata għall-plaċebo ta' >10 msec b'limitu ta' fuq tal-intervall ta' kunfidenza [CI] ta' 90% >15 msec) b'konċentrazzjoni terapewtika (Jum 3) bl-użu tal-metodu ta' korrezzjoni tal-linja bażi fil-ġurnata, u b'konċentrazzjoni akbar minn dik terapewtika (Jum 9) bl-użu taż-żewġ metodi ta' korrezzjoni tal-linja bażi.
English: HDPE BOTTLE - 37.5 MG CAPSULES
Maltese: TAL-HDPE - 37.5
English: One patient with pulmonary embolism in the cytokine-refractory MRCC study experienced dose interruption.
Maltese: Il-metabolit attiv maġġur ma kienx evalwat għal potenzjal ġenotossiku.
English: The safety profile of sunitinib has been derived from a Phase 1 dose-escalation study, a Phase 2 open-label study, a Phase 1/2 single-arm study and from publications as described below.
Maltese: Il-profil ta' sigurtà ta' sunitinib ġie derivat minn studju ta' eskalazzjoni ta' doża ta' Fażi 1, studju b'tikketta open-label ta' Fażi 2, studju ta' fergħa waħda ta' Fażi 1/2 u minn pubblikazzjonijiet kif deskritt hawn taħt.
English: • Acid heartburn.
Maltese: • Diffikultà biex torqod.
English: Sunitinib and/or its metabolites are excreted in rat milk.
Maltese: Sunitinib u/jew il-metaboliti huma eliminati fil-ħalib tal-far.
English: Abbreviations: CI=confidence interval; N=number of patients; PFS=progression-free survival; pNET=pancreatic neuroendocrine tumours.
Maltese: Tqassir: CI=Intervall ta' kunfidenza; N=numru ta' pazjenti; PFS=soprvivenza ħielsa mill-progressjoni; pNET=tumuri newroendokrini tal-frixa
English: Acne
Maltese: Murliti
English: PFS (weeks)
Maltese: PFS (ġimgħat)
English: • Complication of severe infection (infection is present in the bloodstream) that can lead to tissue damage, organ failure, and death.
Maltese: • Kumplikazzjoni ta' infezzjoni severa (infezzjoni preżenti fil-fluss tad-demm) li tista' twassal għal ħsara fit-tessut, insuffiċjenza tal-organi, u mewt.
English: Haemorrhagic events, some of which were fatal, reported in clinical studies with sunitinib and during postmarketing surveillance have included gastrointestinal, respiratory, urinary tract, and brain haemorrhages (see section 4.8).
Maltese: L-episodji ta' emorraġija, li wħud minnhom kienu fatali, li ġew irrappurtati fi studji kliniċi b'sunitinib u waqt sorveljanza ta' wara t-tqegħid tal-prodott fis-suq, kienu jinkludi emorraġiji gastro-intestinali, respiratorji, tat-tumur, ta' l-apparat urinarju u tal-moħħ (ara sezzjoni 4.8).
English: Subject did not progress or die [n (%)] Subject observed to have progressed or died [n (%)]
Maltese: Pazjent li mhux magħruf jekk mietx [n (%)] Pazjent li miet [n (%)] OS (ġimgħat)
English: In this study, 312 patients were randomised (2:1) to receive either 50 mg sunitinib or placebo, orally once daily on Schedule 4/2 until disease progression or withdrawal from the study for another reason (207 patients received sunitinib and 105 patients received placebo).
Maltese: F'dan l-istudju, 312-il pazjent kienu randomised (2:1) li jingħataw jew 50 mg sunitinib jew plaċebo, oralment darba kuljum fuq Skeda 4/2 sakemm kien hemm progressjoni tal-marda jew tneħħew mill-istudju għal raġuni oħra (207 pazjenti ngħataw sunitinib u 105 pazjenti ngħataw plaċebo).
English: - If you have thyroid glands problems.
Maltese: - Jekk għandek problemi fil-glandola tat-tirojde.
English: Flatulence
Maltese: Panċitopenja
English: The risk of cardiac adverse drug reactions appeared to be higher in paediatric patients with previous exposure to cardiac irradiation or anthracycline compared to those paediatric patients without previous exposure.
Maltese: Ir-riskju ta' reazzjonijiet avversi tal-mediċina kardijaka deher li kien ogħla f'pazjenti pedjatriċi li kienu esposti qabel għal irradjazzjoni kardijaka jew għal anthracycline meta mqabbel ma' dawk il-pazjenti pedjatriċi mingħajr esponiment preċedenti.
English: Bleeding events, excluding epistaxis, were reported in 21.7% of patients receiving sunitinib in the Phase 3 pNET study compared to 9.85% of patients receiving placebo (see section 4.4)
Maltese: Seħħew reazzjonijiet emorraġiċi, inkluż epistassi, f'21.7% tal-pazjenti li kienu qed jirċievu sunitinib fil-istudju pNET ta' Fażi 3 meta mqabbel ma' 9.5% tal-pazjenti li kienu qed jirċievu l-plaċebo (ara sezzjoni 4.4).
English: There were 9 deaths in the sunitinib arm and 21 deaths in the placebo arm.
Maltese: Kien hemm 9 imwiet fil-grupp li ħa sunitinib u 21 mewt fil-grupp li ħa plaċebo.
English: Bleeding.
Maltese: Treddigħ
English: Hepatic dysfunction has been reported and may include Liver Function Test abnormalities, hepatitis, or liver failure (see section 4.4).
Maltese: Problemi fil-funzjoni tal-fwied kienu rappurtati, u dawn jistgħu jinkludu anormalitajiet fit-Testijiet talFunzjoni tal-Fwied, epatite u insuffiċjenza tal-fwied (ara sezzjoni 4.4).
English: Increases in the QTc interval to over 500 msec were reported in 0.5%, and changes from baseline in excess of 60 msec were reported in 1.1% of the 450 solid tumour patients; both of these parameters are recognised as potentially significant changes.
Maltese: Żidiet fl-intervall QTc għal iżjed minn 500 msec seħħew f'0.5% u l-bidliet mil-linja bażi li qabżu 60 msec seħħew f'1.1% tal-450 pazjent b'tumuri solidi; dawn iż-żewġ parametri huma rikonoxxuti bħal bidliet potenzjalment sinifikanti.
English: • Stroke.
Maltese: • Sturdament
English: Invasive dental procedures are also an identified risk factor.
Maltese: Proċeduri dentali invażivi huma wkoll identifikati bħala fattur ta' riskju.
English: Lipase increased Platelet count decreased
Maltese: Disturbi filfwied u filmarrara
English: - Pancreatic neuroendocrine tumours (pNET) (tumours of the hormone-producing cells in the pancreas) that have progressed or cannot be removed with surgery.
Maltese: - Tumuri newroendokrinali fil-frixa (pNET) (tumuri li joriġinaw fiċ-ċelloli tal-frixa li jnixxu lormoni) li kibru u li ma jistgħux jitneħħew b'operazzjoni.