FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects with Zejula (which may affect more than 1 in 10 people) are nausea (feeling sick), thrombocytopenia (low blood platelet counts), tiredness and weakness, anaemia (low red blood cell counts), constipation, vomiting, abdominal (belly) pain, neutropenia (low levels of neutrophils, a type of white blood cell), insomnia (difficulty sleeping), headache, lack of appetite, nasopharyngitis (inflammation of the nose and throat), diarrhoea, dyspnoea (difficulty breathing), hypertension (high blood pressure), dyspepsia (heartburn), back pain, dizziness, cough, urinary tract infection (infection of the structures that carry urine), joint pain, palpitations and dysgeusia (taste disturbances).
Maltese: L-effetti sekondarji l-aktar komuni b'Zejula (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma nawsja (tħossok ma tiflaħx), tromboċitopenja (għadd baxx tal-pjastrini fid-demm), għeja u dgħufija, anemija (għadd baxx taċ-ċelloli ħomor tad-demm), stitikezza, remettar, uġigħ addominali (ta' żaqq), newtropenja (livelli baxxi ta' newtrofili, tip ta' ċellola bajda tad-demm), insonnja (diffikultà biex torqod), uġigħ ta' ras, nuqqas ta' aptit, nażofarinġite (infjammazzjoni tal-imnieħer u tal-gerżuma), dijarea, dispnea (diffikultà biex tieħu nifs), ipertensjoni (pressjoni tad-demm għolja), dispepsja (ħruq ta' stonku), uġigħ fid-dahar, sturdament, sogħla, infezzjoni fl-apparat tal-awrina (infezzjoni talistrutturi li jġorru l-awrina), uġigħ fil-ġogi, palpitazzjonijiet u disgewżja (disturbi fit-togħma).
English: Serious side effects include thrombocytopenia and anaemia.
Maltese: Effetti sekondarji serji jinkludu tromboċitopenja u anemija.
English: Other information about Zejula
Maltese: Informazzjoni oħra dwar Zejula
English: The full EPAR for Zejula can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Zejula can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Zejula jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Why is Zejula approved?
Maltese: Għaliex ġie approvat Zejula?
English: This is a summary of the European public assessment report (EPAR) for Zejula.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Zejula.
English: Zejula is available as capsules (100 mg) to be taken by mouth.
Maltese: Zejula jiġi bħala kapsuli (100 mg) li għandhom jittieħdu mill-ħalq.
English: Zejula is a cancer medicine used in adult women with a type of advanced cancer of the ovary called ‘high grade serous epithelial ovarian cancer', including cancer of the fallopian tubes (the tubes connecting the ovaries to the uterus) and cancer of the peritoneum (the membrane lining the abdomen).
Maltese: Zejula huwa mediċina tal-kanċer li tintuża f'nisa adulti b'tip ta' kanċer avvanzat tal-ovarji li jissejjaħ “kanċer ovarjan epiteljali seruż ta' grad għoli”, inkluż kanċer tat-tubi fallopjani (it-tubi li jgħaqqdu lovarji mal-utru) u kanċer tal-peritonew (il-membrana li tiksi l-addome).
English: Patients treated with Zejula lived on average 11.3 months without their disease getting worse compared with 4.7 months in patients treated with placebo (a dummy treatment).
Maltese: Il-pazjenti kkurati b'Zejula għexu medja ta' 11.3 xhur mingħajr ma l-marda tagħhom aggravat meta mqabbla ma' 4.7 xhur f'pazjenti kkurati bil-plaċebo (kura finta).
English: The active substance in Zejula, niraparib, blocks the action of enzymes called PARP-1 and PARP-2, which help to repair damaged DNA in cells when the cells divide to make new cells.
Maltese: Is-sustanza attiva f'Zejula, niraparib, timblokka l-azzjoni ta' enzimi li jissejħu PARP-1 u PARP-2, li jgħinu biex isewwu DNA bi ħsara f'ċelloli meta ċ-ċelloli jinqasmu biex jagħmlu ċelloli ġodda.
English: What are the risks associated with Zejula?
Maltese: X'inhuma r-riskji assoċjati ma' Zejula?
English: Patients in the study had high grade serous epithelial ovarian cancer, including fallopian tube or peritoneal cancers.
Maltese: Il-pazjenti fl-istudju kellhom kanċer ovarjan epiteljali seruż ta' grad għoli, inkluż kanċers tat-tubi fallopjani u periteonali.
English: Because the number of patients with ovarian cancer is low, the disease is considered ‘rare', and Zejula was designated an ‘orphan medicine' (a medicine used in rare diseases) on 4 August 2010.
Maltese: Peress li n-numru ta' pazjenti li jbatu minn kanċer ovariku huwa baxx, il-marda hija kkunsidrata ‘rari', u Zejula ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fl-4 ta' Awwissu 2010.
English: Regarding safety, side effects are generally manageable with dose reductions.
Maltese: Fir-rigward tas-sigurtà, ġeneralment l-effetti sekondarji jistgħu jiġu mmaniġġjati bi tnaqqis fid-doża.
English: Zejula has been shown to prolong the time before the disease gets worse again in patients who have responded to platinum-based therapies.
Maltese: Dan jista' jippermetti li jiġi mdewwem iċ-ċiklu li jmiss ta' terapija bbażata fuq il-platinu.
English: Although treatments for advanced, relapsed ovarian cancer are available, the disease inevitably comes back again.
Maltese: Għalkemm hemm disponibbli kuri għal kanċer ovarjan rikadut avvanzat, il-marda inevitabbilment terġa' tirritorna.
English: For the full list of all side effects reported with Zejula, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Zejula, ara l-fuljett ta' tagħrif.
English: Zejula has been shown to increase the time patients lived without their disease getting worse in one main study involving 553 patients.
Maltese: Fi studju ewlieni li involva 553 pazjent, Zejula ntwera li jżid iż-żmien li jgħixu l-pazjenti mingħajr ma lmarda tagħhom tiggrava.
English: The dose is 3 capsules per day, taken together at the same time each day.
Maltese: Id-doża hija ta' 3 kapsuli kuljum, li jittieħdu fl-istess ħin kull jum.
English: The European Medicines Agency therefore decided that Zejula's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Għaldaqstant, l-Aġenzija Ewropea għall-Mediċini ddeċidiet li l-benefiċċji ta' Zejula huma akbar mir-riskji tiegħu u rrakkomandat li jkun approvat għall-użu fl-UE.
English: * Including fatal events.
Maltese: Inklużi avvenimenti fatali.
English: Safety and tolerability
Maltese: Sigurtà u tolerabbilità
English: From a 2-sided log-rank test.
Maltese: Minn test 2-sided log-rank.
English: Date of first authorisation: 19 July 2006 Date of latest renewal: 9 November 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 19 ta' Lulju 2006 Data tal-aħħar tiġdid: 9 ta' Novembru 2016
English: Long-term safety in MRCC
Maltese: Sigurtà fit-tul f'MRCC
English: Do not take Sutent:
Maltese: Tiħux Sutent:
English: IT-63100 Marino del Tronto (Ascoli Piceno) Italy
Maltese: IT-63100 Marino del Tronto (Ascoli Piceno) L-Italja
English: a 2-sided unstratified log-rank test b
Maltese: a test 2-sided log-rank b
English: Pfizer Ελλάς A.E. (Cyprus Branch) Tηλ.
Maltese: Pfizer Ελλάς A.E. (Cyprus Branch)
English: Metabolic interactions
Maltese: Interazzjonijiet metaboliċi
English: d Oesophageal candidiasis and oral candidiasis.
Maltese: Kandidjasi esofagali u kandidjasi orali.
English: z Amylase and amylase increased.
Maltese: Amylase u żieda fl-amylase.
English: Thrombotic microangiopathy (TMA)
Maltese: Mikroanġjopatija trombotika (TMA)
English: • Problems with wound healing after surgery.
Maltese: • Problemi bil-fejqan ta' feriti wara intervent kirurġiku.
English: Adverse reactions reported in clinical trials
Maltese: Reazzjonijet avversi rrapportati fil-provi kliniċi
English: Final
Maltese: Finali
English: The active substance is sunitinib.
Maltese: Is-sustanza attiva hija sunitinib.
English: Hazard Ratio = 0.42 95% CI (0.26 - 0.66) p = 0.0001
Maltese: 42 95% CI (0.26 - 0.66) p = 0.0001
English: The genotoxic potential of sunitinib was assessed in vitro and in vivo.
Maltese: Il-potenzjal ġenotossiku ta' sunitinib kien assessjat in vitro u in vivo.
English: Palmar-plantar erythrodysaesthesia syndrome Rashu
Maltese: Sindromu palmarplantar eritrodisasteżija Raxx
English: You will usually be taken off Sutent if you are having an operation.
Maltese: Normalment Sutent jitwaqqaf jekk ser tagħmel operazzjoni.
English: Placebo (N = 85)
Maltese: Plaċebo (n = 85)
English: Weight, performance status
Maltese: Piż, status tal-prestazzjoni
English: Sepsis and sepsis shock.
Maltese: Sepsis u xokk settiku.
English: g Abdominal abscess, abdominal sepsis, diverticulitis, and osteomyelitis.
Maltese: Axxessi addominali, sepsis addominali, divertikulite u osteomijelite.
English: No patients had a QTc interval > 500 msec.
Maltese: L-ebda pazjent ma kellu valur QTc >500 msec.
English: • Infections.
Maltese: • Infezzjonijiet.
English: Some of the epistaxis events were severe, but very rarely fatal.
Maltese: Uħud minn dawn lepisodji ta' epitassi kienu serji, imma rarament fatali.
English: 28 x 1 hard capsules
Maltese: 28 x 1 kapsula iebsa
English: The PK of sunitinib were evaluated in 135 healthy volunteers and 266 patients with solid tumours.
Maltese: Il-PK ta' sunitinib ġew evalwati f'135 voluntiera f'saħħithom u 266 pazjent b'tumuri solidi.
English: Hypersensitivity/angioedema
Maltese: Sensittivita' eċċessiva/Anġjoedema
English: The primary efficacy endpoint was ORR, based on Response Evaluation Criteria in Solid Tumours (RECIST).
Maltese: Il-punt ta' tmiem ta' leffikaċja primarja kien ORR, ibbażata fuq Kriterji ta' Evalwazzjoni tar-Reazzjoni f'Tumuri Solidi (RECIST).
English: q Gastrointestinal perforation and intestinal perforation.
Maltese: Perforazzjoni gastrointestinali u perforazzjoni intestinali.
English: Interim 24.1 (11.1, 28.3) 6.0 (4.4, 9.9) 0.333 (0.238, 0.467) < 0.001 Final
Maltese: Waqt l-analiżi 24.1 (11.1, 28.3) 6.0 (4.4, 9.9) 0.333 (0.238, 0.467) < 0.001
English: The calculated in vitro Ki values for all cytochrome P450 (CYP) isoforms tested (CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/5, and CYP4A9/11) indicated that sunitinib and its primary active metabolite are unlikely to induce metabolism, to any clinically relevant extent, of other actives substances that may be metabolised by these enzymes.
Maltese: Il-valuri Ki kkalkulati in vitro għall-iżoformi ċitokromi P450 (CYP) kollha ttestjati (CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/5 u CYP4A9/11) indikaw li sunitinib u l-metabolit attiv primarju tiegħu mhux probabbli li jinduċu l-metaboliżmu ta' sustanzi attivi oħra li jistgħu jiġu metabolizzati b'mod klinikament rilevanti minn dawn l-enzimi.
English: Primary TTP (weeks) Interim 27.3 (16.0, 32.1) 6.4 (4.4, 10.0) 0.329 (0.233, 0.466) < 0.001 Final
Maltese: Waqt l-analiżi 27.3 (16.0, 32.1) 6.4 (4.4, 10.0) 0.329 (0.233, 0.466) < 0.001
English: • Severe reaction of the skin and/or mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
Maltese: • Reazzjoni severa fil-ġilda u/jew fil-membrani mukużi (sindromu ta' Stevens-Johnson, nekrolisi epidermali tossika, eritema multiformi).
English: The primary active metabolite comprises 23% to 37% of the total exposure.
Maltese: Il-metabolit attiv primarju jinkludi 23 sa 37% tal-esponiment totali.
English: A total of 66% of sunitinib patients received prior systemic therapy compared with 72% of placebo patients.
Maltese: Total ta' 66% tal-pazjenti fuq sunitinib irċevew terapija sistemika preċedenti meta pparagunat ma' 72% tal-pazjenti fuq plaċebo.
English: Objective response rate [%, (95% CI)]
Maltese: Rata oġġettiva ta' rispons [%, (95% CI)]
English: Eight of these patients had DVT; 1 with Grade 1, 2 with Grade 2, 4 with Grade 3, and 1 with Grade 4.
Maltese: Tmien pazjenti minnhom kellhom DVT; 1 bi Grad 1, 2 bi Grad 2, 4 bi Grad 3 u 1 bi Grad 4.
English: The apparent volume of distribution (Vd) for sunitinib was large, 2230 L, indicating distribution into the tissues.
Maltese: Ilvolum ta' distribuzzjoni (Vd) evidenti għal sunitinib kien kbir, 2230 L, li jindika distribuzzjoni fittessuti.
English: Kaplan-Meier plot of PFS in the pNET Phase 3 study
Maltese: Figura 1 - Plott Kaplan-Meier ta' PFS fl-Istudju pNET ta' Fażi 3
English: Other endpoints included OS, ORR, PROs, and safety.
Maltese: Endpoints oħra kienu jinkludu OS, ORR, PROs u s-sigurtà.
English: Systemic exposures after a single dose of sunitinib were similar in subjects with severe renal impairment (CLcr < 30 ml/min) compared to subjects with normal renal function (CLcr > 80 ml/min).
Maltese: Esponiment sistemiku wara doża waħda ta' sunitinib kien simili f'suġġetti b'indeboliment renali sever (CLcr <30 ml/min) meta kkumparat ma suġġetti b'funzjoni renali normali (CLcr >80 ml/min).
English: High-density polyethylene (HDPE) bottle with a polypropylene closure containing 30 hard capsules.
Maltese: Flixkun ta' high-density polyethylene (HDPE) b'tapp tal-polypropylene, li fih 30 kapsula iebsa.
English: Poly(chlorotrifluoroethylene)/PVC transparent perforated unit dose blister with aluminium foil coated with heat seal lacquer containing 28 x 1 hard capsules.
Maltese: Folja trasparenti ta' Poly(chlorotrifluoroethylene)/PVC b'folja ta' l-aluminjum miksija u ssiġġillata b'lega msaħnna, li fiha 28 x 1 kapsuli ibsin.
English: h Thrombotic microangiopathy, thrombotic thrombocytopenic purpura, and haemolytic uraemic syndrome.
Maltese: Mikroanġjopatija trombotika, purpura tromboċitopenika trombotika, sindromu uremiku emolitiku.
English: Acquired hypothyroidism was noted in 6.2% of GIST patients on sunitinib versus 1% on placebo.
Maltese: Ipotirojdiżmu miksub kien innotat f'6.2% tal- pazjenti GIST fuq sunitinib versus 1% fuq plaċebo.
English: It is available in plastic bottles of 30 capsules and in perforated unit dose blisters containing 28 x 1 capsules.
Maltese: Jiġi fi fliexken tal-plastik ta' 30 pillola u f'folji ta' 28 x 1 kapsula.
English: Sutent was not studied in subjects with severe (Child-Pugh Class C) hepatic impairment.
Maltese: Sutent ma ġiex studjat f'suġġetti b'indeboliment epatiku qawwi (Klassi Child-Pugh C).
English: Hypertension has been reported in association with sunitinib, including severe hypertension (> 200 mmHg systolic or 110 mmHg diastolic).
Maltese: Ġiet irrapportata pressjoni għolja f'assoċjazzjoni ma' sunitinib, inkluż pressjoni għolja severa (> 200 mmHg sistolika jew 110 mmHg dijastolika).
English: Pfizer Ελλάς A.E. Τλ: +30 210 6785 800
Maltese: Τλ: +30 210 6785 800.
English: Co-administration with medicinal products that are BCRP inhibitors In vitro, sunitinib is a substrate of the efflux transporter BCRP.
Maltese: L-għoti flimkien ma' prodotti mediċinali li huma impedituri ta' BCRP In vitro, sunitinib huwa substrat tat-trasportatur tal-effluss ta' BCRP.
English: Gastrointestinal stromal tumours
Maltese: Tumuri stromali gastrointestinali
English: Severe hypertension (> 200 mmHg systolic or 110 mmHg diastolic) was reported in 4.7% of patients with solid tumours.
Maltese: Pressjoni għolja qawwija (> 200 mmHg sistolika jew 110 mmHg dijastolika) seħħet f'4.7% tal-pazjenti b'tumuri solidi.
English: Tumour lysis syndrome (TLS)
Maltese: Sindromu tad-disintegrazzjoni tat-tumur (TLS)
English: Moxifloxacin (400 mg) used as a positive control showed a 5.6 msec maximum mean QTcF interval change from baseline.
Maltese: Moxifloxacin (400 mg) użat bħala kontroll pożittiv wera bidla massima medja fl-intervall QTcF mil-linja bażi ta' 5.6 msec.
English: In vitro, binding of sunitinib and its primary active metabolite to human plasma protein was 95% and 90%, respectively, with no apparent concentration dependence.
Maltese: In vitro, l-irbit ta' sunitinib u l-metabolit attiv primarju tiegħu ma' proteina fil-plażma umana f'assaġġi in vitro kien 95% u 90%, rispettivament, mingħajr l-ebda dipendenza tal-konċentrazzjoni evidenti.
English: Sunitinib is metabolised primarily by CYP3A4, the CYP isoform which produces its primary active metabolite, desethyl sunitinib, which is then further metabolised by the same isoenzyme.
Maltese: Sunitinib huwa metabolizzat prinċipalment minn CYP3A4, l-isoforma CYP, li tipproduċi l-metabolit attiv primarju tiegħu, desethyl sunitinib, li mbagħad huwa metabolizzat aktar mill-istess isoenzima.
English: In 1 study, hypothyroidism was reported in 15 (13.6%) patients on sunitinib and 3 (2.9%) patients on standard of care.
Maltese: Fi studju 1, ġie rrappurtat ipotirodjiżmu fi 15 (13.6%)-il pazjent fuq sunitinib u fi 3 (2.9%) pazjenti b'terapija standard.
English: Cholecystitis and acalculous cholecystitis.
Maltese: Koleċistite u koleċistite acalculous.
English: In study A6181038 the co-administration of gefitinib, a BCRP inhibitor, did not result in a clinically relevant effect on the Cmax and AUC for sunitinib or total drug (sunitinib + metabolite) (see section 4.5).
Maltese: Fl-istudju A6181038 l-għoti flimkien ta' gefitinib, impeditur ta' BCRP, ma rriżultax f'effett klinikament rilevanti fuq is-Cmax u lAUC għal sunitinib jew il-mediċina totali (sunitinib + metabolit) (ara sezzjoni 4.5).
English: - Printing ink: shellac, propylene glycol, potassium hydroxide, black iron oxide (E172).
Maltese: - Il-linka tal-istampar: shellac, propylene glycol, potassium hydroxide, black iron oxide (E172).
English: Pancreatic neuroendocrine tumours (pNET)
Maltese: Tumuri newroendokrinali fil-frixa (pNET)
English: Median overall OS was 5.1 months in the HGG group and 12.3 months in the ependymoma group.
Maltese: L-OS ġenerali medjana kienet ta' 5.1 xhur fil-grupp ta' HGG u 12.3 xhur fil-grupp ta' ependimoma.
English: The difference in overall survival (OS) was statistically in favour of sunitinib [hazard ratio (HR): 0.491; (95% CI: 0.290, 0.831)]; the risk of death was 2 times higher in patients in the placebo arm compared to the sunitinib arm.
Maltese: Id-differenza fis-sopravivenza totali (OS, overall survival) kienet statistikament favur ta' sunitinib [proporzjon ta' riskju: 0.491; (95% CI: 0.290, 0.831)]; ir-riskju ta' mewt kien darbtejn ogħla f'pazjenti fid-driegħ tal-plaċebo mqabbla mad-driegħ ta' sunitinib.
English: Dose reductions occurred in 194 patients (52%) on sunitinib and 98 patients (27%) on IFN-α.
Maltese: Kien hemm nuqqas fid-doża f'194 pazjenti (52%) li qed jirċievu sunitinib u 98 pazjenti (27%) li qed jirċievu IFN-.
English: Approximately 22.2% of patients with solid tumours, including GIST and MRCC, who received sunitinib in clinical trials experienced pulmonary events.
Maltese: Madwar 22.2% tal-pazjenti b'tumuri solidi, inkluż GIST u MRCC, li rċivew sunitinib fil-provi kliniċi esperjenzaw reazzjonijiet pulmonari.
English: Thrombotic microangiopathyh,*
Maltese: Mikroanġj opatija trombotika h,*
English: Prolongation of QT interval and Torsade de pointes have been observed in sunitinib-exposed patients.
Maltese: Titwil tal-intervall QT u Torsade de pointes ġew osservati f'pazjenti esposti għal sunitinib.
English: Dose interruptions occurred in 202 patients (54%) on sunitinib and 141 patients (39%) on IFN-α.
Maltese: Kien hemm interruzjonijiet tad-doża f'202 pazjenti (54%) li qed jirċievu sunitinib u 141 pazjenti (39%) li qed jirċievu IFN-.
English: In healthy volunteers, concomitant administration of a single dose of sunitinib with the potent CYP3A4 inhibitor ketoconazole resulted in an increase of the combined [sunitinib + primary metabolite] maximum concentration (Cmax) and area under the curve (AUC0-) values of 49% and 51%, respectively.
Maltese: F'voluntiera b'saħħithom, l-amministrazzjoni konkomitanti ta' doża waħda ta' sunitinib ma' ketoconazole, impeditur ta' CYP3A4 potenti, irriżultat f'żieda fil-valuri kombinati [sunitinib + metabolit primarju] konċentrazzjoni massima (Cmax) u valuri tal-erja taħt il-kurva (AUC0-) ta' 49% u 51%, rispettivament.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors; ATC code: L01XE04
Maltese: Aġenti anti-neoplastiċi, impedituri tal-protein kinase, Kodiċi ATC:
English: • Abnormal sensations in extremities.
Maltese: • Sensazzjoni annormali fl-estremitajiet.
English: In addition, the publications reported the following Grade 3 adverse drug reactions experienced by 5 patients: fatigue (2), gastrointestinal adverse drug reactions (including diarrhoea) (2), haematologic adverse drug reactions (including anaemia) (2), cholecystitis (1), hyperthyroidism (1), and mucositis (1).
Maltese: Barra minn hekk, fil-pubblikazzjonijiet huma rrappurtati r-reazzjonijiet avversi tal-mediċina ta' Grad 3 li ġejjin esperjenzati minn 5 pazjenti: għeja (2), reazzjonijiet avversi tal-mediċina gastrointestinali (inkluż dijarea) (2), reazzjonijiet avversi tal-mediċina ematoloġiċi (inkluż anemija) (2), koleċistite (1), ipertirojdiżmu (1) u mukożite (1).
English: • Inflammation of the liver (hepatitis).
Maltese: • Infjammazjoni fil-fwied (epatite).
English: QT interval prolongation may lead to an increased risk of ventricular arrhythmias including Torsade de pointes.
Maltese: It-titwil ta' l-intervall QT jista' jwassal għal żieda fir-riskju ta' arritmiji ventrikulari inkluż Torsade de pointes.
English: Sunitinib inhibits multiple RTKs that are implicated in tumour growth, neoangiogenesis, and metastatic progression of cancer.
Maltese: Sunitinib jimpedixxi RTKs multipli li huma implikati fl-iżvilupp tat-tumur, neoanġjoġenesi, u progressjoni metastatika tal-kanċer.
English: Rare: may affect up to 1 in 1,000 people
Maltese: Rari: jaffettwa sa persuna 1 minn kull 1,000
English: Median OS in the ITT population was 72.7 weeks and 64.9 weeks (HR: 0.876; 95% CI: 0.679, 1.129; p=0.306), in the sunitinib and placebo arms, respectively.
Maltese: Il-medjan ta' OS fil-poplazzjoni ITT kienet ta' 72.7 ġimgħat u 64.9 ġimgħat (HR: 0.876; 95% CI: 0.679,1.129; p=0.306), fid-driegħ ta' sunitinib u plaċebo rispettivament.
English: Median PFS was 2.3 months in the HGG group and 2.7 months in the ependymoma group.
Maltese: Il-PFS medjana kienet ta' 2.3 xhur fil-grupp ta' HGG u 2.7 xhur fil-grupp ta' ependimoma.
English: Treatment-related venous thromboembolic events were reported in patients who received sunitinib including deep venous thrombosis and pulmonary embolism (see section 4.8).
Maltese: Reazzjonijiet tromboemboliċi venużi, relatati mat-trattament, kienu rrapurtati f'pazjenti li rċivew sunitinib inkluż trombożi venuża profonda u emboliżmu pulmonari (ara sezzjoni 4.8).
English: Excretion is primarily via faeces (61%), with renal elimination of unchanged active substance and metabolites accounting for 16% of the administered dose.
Maltese: L-eliminazzjoni hija prinċipalment ma' l-ippurgar (61%) b'eliminazzjoni renali ta' sustanza attiva mhix mibdula u l-metaboliti tammonta għal 16% tad-doża amministrata.
English: This analysis provided a conservative estimate of the treatment effect of sunitinib and supported the primary analysis, demonstrating a hazard ratio of 0.507 (95% CI: 0.350, 0.733), p=0.000193.
Maltese: Din l-analiżi pprovdiet stima konservattiva tal-effett tat-trattament b'sunitinib u appoġġja l-analiżi primarja, billi wriet proporzjon ta' riskju ta' 0.507 (95% CI 0.350, 0.733), p = 0.000193.
English: In a pancreatic islet cell tumour cohort of 66 patients, the primary endpoint of response rate was 17%.
Maltese: Fi grupp ta' 66 pazjent b'islet cell tumour fil-frixa, l-endpoint primarju tar-rata ta' rispons kien 17%.
English: Following oral administration in healthy volunteers, the elimination half-lives of sunitinib and its primary active desethyl metabolite are approximately 40-60 hours and 80-110 hours, respectively.
Maltese: Wara għoti orali lil voluntiera b'saħħithom, il-half-lives tal-eliminazzjoni ta' sunitinib u tal-metabolit attiv primarju tiegħu desethyl huma bejn wieħed u ieħor 40-60 siegħa, u 80-110 sigħat, rispettivament.
English: OS observed after 5 years of follow-up in the extension study showed a hazard ratio of 0.730 (95% CI: 0.504, 1.057).
Maltese: OS osservata wara 5 snin ta' segwitu flistudju ta' estensjoni wriet proporzjon ta' periklu ta' 0.730 (95% CI 0.504, 1.057).