FrancophonIA/ELRC3.0 huggingface dataset:
English: Rivastigmine is rapidly and extensively metabolised (half-life in plasma approximately 1 hour), primarily via cholinesterase-mediated hydrolysis to the decarbamylated metabolite.
Maltese: Rivastigmine jiġi metabolizzat malajr u b'mod estensiv għal metabolit decarbamylated (b'half-life fil-plażma ta' madwar siegħa), prinċipalment permezz ta' idroliżi li ssir b'cholinesterase.
English: Clinical studies in dementia associated with Parkinson's disease The efficacy of rivastigmine in dementia associated with Parkinson's disease has been demonstrated in a 24-week multicentre, double-blind, placebo-controlled core study and its 24-week open-label extension phase.
Maltese: Studji kliniċi ta' dimenzja assoċjati mal-marda ta' Parkinson L-effikaċja ta' rivastigmine f'dimenzja assoċjata mal-marda tal-Parkinson intweriet fi studju ewlieni multiċentriku, double-blind bi plaċebo bħala kontroll ta' 24 ġimgħa u bil-fażi tal-estenzjoni tiegħu ta' 24 ġimgħa bit-tikketta tidher.
English: Care must be taken when using rivastigmine in patients with sick sinus syndrome or conduction defects (sino-atrial block, atrio-ventricular block) (see section 4.8).
Maltese: Attenzjoni għandha tingħata meta rivastigmine jintuża f'pazjenti b'sindromu ta' sinus marid jew b'difetti fit-trasmissjoni (blokk sino-atrijali, blokk atriju-ventrikulari)
English: 2 Mean data shown for convenience, categorical analysis performed using van Elteren test ITT: Intent-To-Treat; RDO: Retrieved Drop Outs; LOCF: Last Observation Carried Forward
Maltese: 2 għal konvenjenza qed tintwera l-medja tad-dejta, l-analiżi kategorika mwettqa skont it-test ta' van Elteren ITT: Intenzjoni li jingħata trattament;
English: If you have to undergo surgery whilst taking Rivastigmine Teva, tell your doctor before you are given any anaesthetics, because Rivastigmine Teva may exaggerate the effects of some muscle relaxants during anaesthesia.
Maltese: Jekk ikollok bżonn ta' intervent kirurġiku waqt li tkun qed tieħu Rivastigmine Teva, għid lit-tabib qabel ma tingħata xi loppju, peress li Rivastigmine Teva jista' jħarrax l-effetti ta' xi rilassanti tal-muskoli li jingħataw waqt l-anesteżija.
English: Adjusted treatment difference p-value versus placebo
Maltese: Differenza tal-kura aġġustat Valur p kontra il-plaċebo
English: Pre-defined adverse events that may reflect worsening of parkinsonian symptoms in patients with dementia associated with Parkinson's disease
Maltese: Każijiet avversi definiti minn qabel li jistgħu jirriflettu aggravar tas-sintomi ta' Parkinson f'pazjenti b'dimenzja assoċjata mal-marda ta' Parkinson
English: Unchanged rivastigmine is not found in the urine; renal excretion of the metabolites is the major route of elimination.
Maltese: Rivastigmine mhux mibdul ma jinstabx fl-awrina; l-eliminazzjoni mill-kliewi tal-metaboliti hija l-mezz ewlieni ta' eliminazzjoni.
English: While bioavailability of rivastigmine is greater in elderly than in young healthy volunteers, studies in Alzheimer patients aged between 50 and 92 years showed no change in bioavailability with age.
Maltese: Filwaqt li l-bijodisponibilità ta' rivastigmine hija ogħla fl-anzjani milli f'żgħażagħ voluntiera b'saħħithom, studji fuq pazjenti li jbatu mill-marda ta' Alzheimer bejn l-etajiet ta' 50 u 92 sena ma wrew l-ebda tibdil fil-bijodisponibilità minħabba età.
English: Capsule contents Microcrystalline cellulose Hypromellose Colloidal silicon dioxide
Maltese: Il-kontenut tal-kapsula Microcrystalline cellulose Hypromellose.
English: Rivastigmine Teva 4.5 mg hard capsules
Maltese: Teva 4.5 mg kapsuli iebsin
English: España Teva Pharma, S.L.U
Maltese: Luxembourg/Luxemburg Teva Pharma Belgium S.A.
English: EU/1/09/513/001 EU/1/09/513/002 EU/1/09/513/003 EU/1/09/513/004 EU/1/09/513/005
Maltese: EU/1/09/513/001 EU/1/09/513/002 EU/1/09/513/003 EU/1/09/513/004
English: EU/1/09/513/011 EU/1/09/513/012 EU/1/09/513/013 EU/1/09/513/014 EU/1/09/513/015
Maltese: EU/1/09/513/011 EU/1/09/513/012 EU/1/09/513/013 EU/1/09/513/014
English: • Fever
Maltese: • Sturdament
English: An initial dose of 0.03 mg/kg intravenous atropine sulphate is recommended, with subsequent doses based on clinical response.
Maltese: Fil-bidu huwa rakkomandat li tintuża doża ta' 0.03 mg/kg atropine sulphate li tingħata minn ġol-vina, bid-dożi ta' wara din ibbażati fuq ir-rispons kliniku.
English: Patients with visual
Maltese: Tnaqqis fil-piż
English: There is no accumulation of rivastigmine or the decarbamylated metabolite in patients with Alzheimer's disease.
Maltese: M'hemmx akkumulazzjoni ta' rivastigmine jew il-metabolit decarbamylated f'pazjenti li jbatu millmarda ta' Alzheimer.
English: Pallagi út 13
Maltese: Tqala u treddigħ
English: Rivastigmine interacts with its target enzymes by forming a covalently bound complex that temporarily inactivates the enzymes.
Maltese: Rivastigmine jaġixxi mal-enzimi bersalljati tiegħu billi jifforma kumpless marbut b'mod kovalenti li temporanjament jagħmel l-enzimi inattivi.
English: Hard capsule Orange cap imprinted with “R” & flesh color body imprinted with “6”
Maltese: Kapsula iebsa Ras oranġjo li fuqha hemm stampat “R” u korp ta' lewn il-ġilda li fuqu hemm stampat “6”
English: The results for clinically relevant responders pooled from two flexible dose studies out of the three pivotal 26-week multicentre studies in patients with mild-to-moderately severe Alzheimer's Dementia, are provided in Table 4 below.
Maltese: Ir-riżultati ta' pazjenti li wrew titjib klinikament rilevanti, li kienu miġbura minn żewġ studji bid-doża flessibbli minn tliet studji ewlenin multiċentrali mifruxa fuq 26 ġimgħa f'pazjenti li jbatu minn Dimenzja ta' Alzheimer minn ħafifa sa moderatament severa, jinsabu f'Tabella 4 hawn isfel.
English: Dose titration: Adverse reactions (e.g. hypertension and hallucinations in patients with Alzheimer's dementia and worsening of extrapyramidal symptoms, in particular tremor, in patients with dementia associated with Parkinson's disease) have been observed shortly after dose increase.
Maltese: Ġew osservati reazzjonijiet avversi (eż. pressjoni għolja u alluċinazzjonijiet f'pazjenti b'dimenzja ta' Alzheimer u sintomi ekstrapiramidali li jmorru għall-agħar, l-aktar rogħda, f'pazjenti b'dimenzja assoċjata mal-marda ta'Parkinson) ftit wara li ġiet miżjuda d-doża.
English: Subjects with renal impairment
Maltese: Mhux magħruf Disturbi Vaskulari
English: Abdominal pain and dyspepsia
Maltese: Uġigħ addominali u dispesja
English: Clinically relevant improvement in these studies was defined a priori as at least 4-point improvement on the ADAS-Cog, improvement on the CIBIC-Plus, or at least a 10 % improvement on the PDS.
Maltese: F'dawn l-istudji, it-titjib klinikament rilevanti kien definit a priori bħala mill-inqas b'4 punti fl-ADAS-Cog, bħala titjib fis-CIBICPlus, jew tal-anqas titjib ta' 10 % fil-PDS.
English: Hypokinesia
Maltese: Bradikinesja
English: Excretion
Maltese: Distonja
English: Very common • Trembling
Maltese: Komuni ħafna • Tregħid
English: No untoward effects on cardiac conduction were observed following concomitant administration of digoxin and rivastigmine.
Maltese: Ma ġew osservati l-ebda effetti ħżiena fuq il-konduttività kardijaka, meta ngħataw digoxin u rivastigmine fl-istess ħin.
English: Patients involved in this study had an MMSE (Mini-Mental State Examination) score of 10 - 24.
Maltese: Il-pazjenti involuti f'dan l-istudju kellhom punteġġ ta' MMSE (Eżami Żgħir talIstat Mentali) ta' 10 - 24.
English: Worsening (including bradykinesia, dyskinesia, gait abnormality) and an increased incidence or severity of tremor have been observed in patients with dementia associated with Parkinson's disease (see section 4.8).
Maltese: Aggravar (li jinkludi bradikardja, diskajniżja, pass mhux normali) u żieda fil-każijiet jew s-severità tat-tregħid f'pazjenti li jbatu b'dimenzja assoċjata mal-marda ta' Parkinson (ara sezzjoni 4.8).
English: Capsule shell Red iron oxide (E172) Yellow iron oxide (E172)
Maltese: Yellow iron oxide (E172)
English: Rivastigmine Teva is used for the treatment of memory disorders in patients with Alzheimer's disease.
Maltese: Teva jintuża għat-trattament ta' disturbi marbuta mal-memorja f'pazjenti b'dimenzja ta' Alzheimer.
English: BN
Maltese: B.
English: Pruritus
Maltese: Lott
English: Gastrointestinal disorders such as nausea, vomiting and diarrhoea are dose-related, and may occur particularly when initiating treatment and/or increasing the dose (see section 4.8).
Maltese: Jista' jkun hemm problemi marbuta mas-sistema gastrointestinali, bħal dardir, remettar u dijarea huma relatati mad-doża u l-aktar meta jinbeda t-trattament u/jew tiżdied id-doża (ara sezzjoni 4.8).
English: The Cmax of rivastigmine was approximately 60 % higher and the AUC of rivastigmine was more than twice as high in subjects with mild to moderate hepatic impairment than in healthy subjects.
Maltese: Is-Cmax ta' rivastigmine kien madwar 60 % ogħla u l-AUC ta' rivastigmine kien aktar mid-doppju f'individwi li kellhom indeboliment tal-fwied minn ħafif sa moderat meta dawn kienu mqabbla ma' individwi b'saħħithom.
English: The efficacy of rivastigmine has been established through the use of three independent, domain specific, assessment tools which were assessed at periodic intervals during 6 month treatment periods.
Maltese: L-effikaċja ta' rivastigmine kienet stabilita permezz ta' tliet għodod indipendenti ta' assaġġ, speċifiċi għad-dominju li kienu assessjati f'intervalli perijodiċi matul perijodi ta' 6 xhur.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 1.5 mg For a full list of excipients, see section 6.1.
Maltese: Kull kapsula fiha rivastigmine hydrogen tartrate li jikkorispondi għal 1.5 mg rivstigmine Għal-lista kompleta ta' sustanzi mhux attivi, ara sezzjoni 6.1.
English: In massive overdose, atropine can be used.
Maltese: F'każ ta' doża eċċesiva, tista' tintuża l-atropina.
English: Rivastigmine is rapidly and completely absorbed.
Maltese: Rivastigmine jiġi assorbit malajr u kompletament.
English: Hypertension
Maltese: Hypromellose
English: The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu jiżgura li s-sistema ta' farmakoviġilanza, kif ippreżentata f'Modulu 1.8.1. tal-Applikazzjoni għal Awtorizzazzjoni għat-Tqegħid fis-Suq qegħda f'postha u qed taħdem qabel u waqt li l-prodott ikun fis-suq.
English: The mean actual daily dose for responders in the 6-12 mg group, corresponding to this definition, was 9.3 mg.
Maltese: Id-doża medja attwali ta' kuljum għal dawk li wrew rispons fil-grupp ta' minn 6 - 12-il mg, li tikkorispondi ma' din id-definizzjoni, hija ta' 9.3 mg.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 6 mg
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull kapsula fiha rivastigmine hydrogen tartrate li jikkorispondi għal 6 mg rivastigmine
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 4.5 mg For a full list of excipients, see section 6.1.
Maltese: Kull kapsula fiha rivastigmine hydrogen tartrate li jikkorispondi għal 4.5 rivastigmine Għal-lista kompleta ta' sustanzi mhux attivi, ara sezzjoni 6.1.
English: Excretion:
Maltese: Τel:
English: 4.9 Overdose
Maltese: .9 Doża eċċċessiva
English: Cmax and AUC of rivastigmine were more than twice as high in subjects with moderate renal impairment compared with healthy subjects; however there were no changes in Cmax and AUC of rivastigmine in subjects with severe renal impairment.
Maltese: Is-Cmax u l-AUC ta' rivastigmine kienu aktar minn darbtejn ogħla f'pazjenti li kellhom indeboliment talkliewi moderat meta dawn kienu mqabbla ma' individwi b'saħħithom; madankollu ma' kien hemm l-ebda tibdiliet fis-Cmax u AUC ta' rivastigmine f'individwi b'indeboliment tal-kliewi sever.
English: PSURs
Maltese: Sturdament
English: Drugsales Ltd Tel: +356 21 419 070/1/2
Maltese: UAB “Sicor Biotech” Tel: +370 5 266 02 03
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 6 mg For a full list of excipients, see section 6.1.
Maltese: Kull kapsula fiha rivastigmine hydrogen tartrate li jikkorispondi għal 6 mg rivastigmine Għal-lista kompleta ta' sustanzi mhux attivi, ara sezzjoni 6.1.
English: Worsening of Parkinson's disease
Maltese: Aggravar tal-marda ta' Parkinson
English: Thus, rivastigmine may have an ameliorative effect on cholinergic-mediated cognitive deficits in dementia associated with Alzheimer's disease and Parkinson's disease.
Maltese: Għalhekk, rivastigmine jista' jkollu effett li jtejjeb id-diffikultajiet ta' għarfien fid-dimenzja li jsiru b'mod kolinerġiku u li huma assoċjati mal-marda ta' Alzheimer u l-marda ta' Parkinson.
English: • Slow heartbeat
Maltese: • Taħbit tal-qalb irregolari
English: - if you have, or have ever had, irregular heartbeat.
Maltese: - jekk int għandek, jew qatt kellek, taħbit tal-qalb irregolari.
English: To be swallowed whole without crushing or opening Read the package leaflet before use
Maltese: Total ta' pazjenti studjati Total ta' pazjenti b'effetti avversi definiti minn qabel
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 3 mg For a full list of excipients, see section 6.1.
Maltese: Kull kapsula fiha rivastigmine hydrogen tartrate li jikkorispondi għal 3 mg Għal-lista kompleta ta' sustanzi mhux attivi, ara sezzjoni 6.1.
English: Rash
Maltese: Folji
English: NAME OF THE MEDICINAL PRODUCT Rivastigmine Teva 3 mg hard capsules Rivastigmine
Maltese: Rivastigmine Teva 3 mg kapsuli iebsin Rivastigmine
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 3 mg
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull kapsula fiha rivastigmine hydrogen tartrate li jikkorispondi għal 3 mg rivastigmine
English: When normalised to body surface area, the exposure to rivastigmine and its metabolites was approximately equivalent to the maximum recommended human dose of 12 mg/day; however, when compared to the maximum human dose, a multiple of approximately 6-fold was achieved in animals.
Maltese: Meta ġew imqabbla mal-erja tas-superfiċje korporali, l-espożizzjoni għal rivastigmine u l-metaboliti tiegħu kien bejn wieħed u ieħor ekwivalenti għad-doża massima rakkomandata fil-bniedem ta' 12 mg/jum; madankollu, meta mqabbla mad-doża massima fil-bniedem, livelli ta' bejn wieħed u ieħor 6 darbiet aktar kienu milħuqa fl-annimali.
English: Extrapyramidal symptoms (including worsening of Parkinson's disease)
Maltese: Sintomi ekstrapiramidali (li jinkludu aggravar tal-marda ta'
English: General disorders and administration site conditions
Maltese: Uġigħ addominali u dispepsja
English: Tell your caregiver that you are taking Rivastigmine Teva.
Maltese: F'każijiet oħra Rivastigmine Teva ġie mwaqqaf.
English: - If you are allergic (hypersensitive) to rivastigmine (the active substance in Rivastigmine Teva)
Maltese: Is-sustanza attiva f'Rivastigmine Teva hija rivastigmine.
English: Treatment effect has not been studied in placebo-controlled trials beyond 6 months.
Maltese: L-effett tat-trattament ma ġiex studjat fi provi, ikkontrollati bi plaċebo għal aktar minn 6 xhur.
English: Dizziness
Maltese: Dijarea
English: Rivastigmine may cause increased gastric acid secretions.
Maltese: Rivastigmine jista' jikkaġuna żieda fit-tnixxijat tal-aċidu gastriku.
English: Capsule shell
Maltese: Il-qoxra tal-kapsula
English: The use of rivastigmine in patients with severe dementia of Alzheimer's disease or associated with Parkinson's disease, other types of dementia or other types of memory impairment (e.g. age-related cognitive decline) has not been investigated and therefore use in these patient populations is not recommended.
Maltese: L-użu ta' rivastigmine f'pazjenti li jbatu b'dimenzja severa ta' Alzheimer jew dik assoċjata mal-marda ta' Parkinson, b'tipi oħra ta' dimenzja jew b'tipi oħra ta' mard li jxekklu l-memorja (eż. tnaqqis fl-għarfien relatat mal-età) għadu ma ġiex mistħarreġ u għalhekk l-użu tiegħu f'dawn il-pazjenti mhuwiex rakkomandat.
English: Patients with mild dementia (MMSE 18-24)
Maltese: Pazjenti b'dimenzja ħafifa (MMSE
English: Fits (seizures)
Maltese: TWISSIJA(IET) SPEĊJALI
English: • The signs of Parkinson's disease get worse or getting similar signs - such as stiff muscles,
Maltese: • Is-sintomi tal-marda ta' Parkinson jaggravaw jew ikollok sintomi simili - eżempju ebusija tal-muskoli,
English: According to its metabolism, metabolic interactions with other medicinal products appear unlikely, although rivastigmine may inhibit the butyrylcholinesterase mediated metabolism of other substances.
Maltese: Minħabba l-metaboliżmu tiegħu, mhux mistenni li jkun hemm interazzjonijiet metaboliċi ma' prodotti mediċinali oħrajn, għalkemm rivastigmine jista' jinibixxi l-metaboliżmu li jsir permezz ta' butrylcholinesterase ta' sustanzi oħra
English: • Chest pain
Maltese: • Telf ta' piż
English: Rivastigmine Teva might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson's disease or to prevent travel sickness).
Maltese: Rivastigmine Teva jista' jinterferixxi ma' mediċini antikolinerġiċi (mediċini li jintużaw biex itaffu weġgħat fl-istonku jew spażmi, għal kura tal-marda ta' Parkinson jew biex jevitaw it-tqalligħ talivjaġġar).
English: Although a treatment effect was demonstrated in the overall study population, the data suggested that a larger treatment effect relative to placebo was seen in the subgroup of patients with moderate dementia associated with Parkinson's disease.
Maltese: Għalkemm intwera effett tat-trattament fil-popolazzjoni globali kollha tal-istudju, id-dejta indikat li kien hemm effett ta' kura aħjar meta mqabbel mal-plaċebo fis-sottogrupp ta' pazjenti b'dimenzja moderata assoċjata mal-marda ta' Parkinson.
English: The secondary definition of response required a 4-point or greater improvement on the ADAS-Cog, no worsening on the CIBIC-Plus, and no worsening on the PDS.
Maltese: Definizzjoni sekondarja ta' rispons kienet teħtieġ titjib ta' 4 punti jew aktar fl-ADAS-Cog, u mingħajr ma' tmur għall-agħar fis-CIBICPlus, u fil-PDS.
English: Pharmacotherapeutic group: anticholinesterases, ATC code: N06D A03
Maltese: N06D A03
English: Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.
Maltese: Trattament ta' sintomi ta' dimenzja li jkunu ħfief għal severi b'mod moderat f'pazjenti bil-marda ta' Parkinson idjopatika.
English: What Rivastigmine Teva looks like and contents of the pack
Maltese: Id-dehra ta' Rivastigmine Teva u l-kontenuti tal-pakkett
English: - 28, 56 or 112 capsules in transparent PVC/Alu push through blisters
Maltese: - Folji trasparenti tal-PVC/Alu li tista' timbotta minnhom ta' 28, 56 jew 112-il kapsula
English: • Liver disorders (yellow skin, yellowing of the whites of eyes, abnormal darkening of the urine or unexplained nausea, vomiting, tiredness and loss of appetite)
Maltese: • Disturbi fil-fwied (ġilda safra, l-abjad tal-għajnejn jisfar, awrina skura b'mod mhux normali jew dardir bla ma taf għala, rimettar, għeja u nuqqas ta' aptit)
English: Following administration of 14C-rivastigmine, renal elimination was rapid and essentially complete (>90 %) within 24 hours.
Maltese: Wara l-għoti ta' 14C-rivastigmine, l-eliminazzjoni mill-kliewi kienet mgħaġġla u kienet kważi kompluta (>90 %) fi żmien 24 siegħa.
English: Like other cholinomimetics, rivastigmine may exacerbate or induce extrapyramidal symptoms.
Maltese: Bħal kolinomimetriċi oħrajn, rivastigmine jista' jħarrax jew jikkaġuna sintomi ekstrapiramidali.
English: NAME OF THE MEDICINAL PRODUCT Rivastigmine Teva 6 mg hard capsules Rivastigmine
Maltese: Rivastigmine Teva 6 mg kapsuli iebsin Rivastigmine
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
Maltese: • KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL-FORNIMENT U L-UŻU IMPOSTI
English: In patients with Alzheimer's disease, inhibition of AChE in CSF by rivastigmine was dose-dependent up to 6 mg given twice daily, the highest dose tested.
Maltese: F'pazjenti li jbatu mill-marda ta' Alzheimer, l-inibizzjoni ta' AChE fis-CSF b'rivastigmine kienet tiddependi fuq id-doża, meta d-doża kienet sa 6 mg darbtejn kuljum, li hija l-ogħla doża ttestjata.
English: It is available as capsules (12.5 mg, 25 mg, 37.5 mg and 50 mg).
Maltese: Jiġi f'kapsuli (12.5 mg, 25 mg, 37.5 mg u 50 mg).
English: EMA/487080/2014 EMEA/H/C/000687
Maltese: EMEA/H/C/000687
English: The full EPAR for Sutent can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Sutent jinsab fuq is-sit tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The most common side effects with Sutent (seen in more than 1 in 10 patients) include fatigue (tiredness), gastrointestinal disorders (such as diarrhoea, feeling sick, inflammation of the lining of the mouth, indigestion and vomiting), respiratory (such as shortness of breath and cough) and skin disorders (such as skin discoloration, dryness of the skin and rash), hair color changes, dysgeusia (taste disturbances), epistaxis (nosebleeds), loss of appetite, hypertension (high blood pressure), palmar-plantar erythrodysaesthesia syndrome (rash and numbness on the palms and soles), hypothyroidism (an underactive thyroid gland), insomnia (difficulty falling and staying asleep), dizziness, headache, arthralgia (joint pain), neutropenia (low levels of neutrophils, a type of white blood cell), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), and leucopenia (low white blood cell counts).
Maltese: L-aktar effetti sekondarji komuni b'Sutent (li dehru f'aktar minn 1 minn kull 10 pazjenti) jinkludu għeja, disturbi gastrointestinali (bħad-dijarea, tħossok ma tiflaħx, infjammazzjoni tar-rita tal-ħalq, indiġestjoni u remettar), disturbi respiratorji (nuqqas ta' nifs u sogħla) u fil-ġilda (ġilda li titlef il-kulur, ġilda xotta u raxx), bidliet fil-kulur tax-xagħar, diżgweżja (distubi fit-togħma), epistassi (fġar), nuqqas ta' aptit, iperteszjoni (pressjoni għolja tad-demm), sindromu ta' eritrodisestesija palmo-plantari (raxx u wġigħ fl
English: This is a summary of the European public assessment report (EPAR) for Sutent.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Sutent.
English: Sutent is a medicine that contains the active substance sunitinib.
Maltese: Sutent huwa mediċina li fih is-sustanza attiva sunitinib.
English: This means that it blocks some specific enzymes known as protein kinases.
Maltese: Dan ifisser li din timblokka ċerti enzimi speċifiċi li jissejħu proteina kinażi.
English: Sutent was more effective than placebo in treating GIST and pancreatic neuroendocrine tumours.
Maltese: Sutent kien iktar effikaċi mill-plaċebo fit-trattament tal-GST u tat-tumuri newroendokrinali pankreatiki.
English: The most serious side effects reported with Sutent include heart and kidney failure, pulmonary embolism (clot in a blood vessel supplying the lungs), gastrointestinal perforation (holes in the wall of the gut), and internal haemorrhages (bleeding).
Maltese: L-aktar effetti sekondarji serji rrappurtati b'Sutent jinkludu insuffiċjenza fil-qalb u fil-kliewi, emboliżmu pulmonari (emboli tad-demm f'vini li jfornu l-pulmun), perforazzjoni gastrointestinali (toqob fir-rita talimsaren), u emorraġiji interni (fsada).
English: It is used after treatment with imatinib (another cancer medicine) has failed;
Maltese: Jintuża wara li l-kura bl-imatinib (mediċina oħra tal-kanċer) tkun falliet;
English: As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.
Maltese: Peress li l-kumpanija forniet l-informazzjoni addizzjonali meħtieġa, l-awtorizzazzjoni ma baqgħetx ikkondizzjonta u saret sħiħa.