FrancophonIA/ELRC3.0 huggingface dataset:
English: Grapefruit juice should be avoided during treatment with pazopanib (see section 4.5).
Maltese: Meraq tal-grejpfrut m'għandux jittieħed waqt it-trattament b'pazopanib (ara sezzjoni 4.5).
English: Common side effects that may show up in your blood or urine tests: - underactive thyroid gland - abnormal liver function - increase in bilirubin (a substance produced by the liver) - increase in lipase (an enzyme involved in digestion - increase in creatinine (a substance produced in muscles) - changes in the levels of other different chemicals / enzymes in the blood.
Maltese: Effetti sekondarji komuni li jistgħu jidhru fit-testijiet tad-demm u l-awrina: - attività mnaqqsa tal-glandula tirojde - funzjoni abnormali tal-fwied - żieda fil-bilirubin (sustanza prodotta mill-fwied) - żieda fil-lipase (enżimu involut fid-diġestjoni) - żieda fil-creatinine (sustanza msawra fil-muskoli) - tibdil fil-livelli ta' kimiċi differenti oħra/enżimi fid-demm.
English: Each Votrient 200 mg film-coated tablet contains 200 mg pazopanib.
Maltese: - Kull pillola miksija b'rita ta' Votrient 200 mg fiha 200 mg pazopanib.
English: One of these metabolites inhibits the proliferation of VEGF-stimulated human umbilical vein endothelial cells with a similar potency to that of pazopanib, the others are 10- to 20-fold less active.
Maltese: Wieħed minn dawn ilmetaboliti jistimula t-tkattir ta' ċelloli tal-endotilju tal-vina umbilika umana stimulat mill-VEGF blistess saħħa ta' dik ta' pazopanib, l-oħrajn huma 10- sa 20-darba inqas attivi.
English: In clinical studies with pazopanib, events of hypothyroidism have occurred (see section 4.8).
Maltese: Fi studji kliniċi b'pazopanib, kienu rrapportati avvenimenti ta'emorraġija (ara sezzjoni 4.8).
English: CYP3A4 inducers such as rifampin may decrease plasma pazopanib concentrations.
Maltese: Indutturi ta' CYP3A4 bħal rifampin jistgħu jnaqqsu l-konċentrazzjoni tal-pazopanib fil-plażma.
English: Myocardial dysfunction occurred in 13% (47/362) of subjects in the pazopanib arm compared to 11% (42/369) of subjects in the sunitinib arm. Congestive heart failure was observed in 0.5% of subjects in each treatment arm. Congestive heart failure was reported in 3 out of 240 subjects (1%) in the Phase III VEG110727 STS study.
Maltese: Disfunzjoni mijokardijaka seħħet fi 13% (47/362) tal-individwi fil-fergħa ta' pazopanib meta mqabbel ma' 11% (42/369) tal-individwi fil-fergħa ta' sunitinib.
English: Anal haemorrhage
Maltese: Mhux magħrufa
English: Ileal perforation
Maltese: TAL-PRODOTT
English: Melaena
Maltese: Rimettar
English: Hiccups
Maltese: Puplesija
English: Votrient is indicated for the treatment of adult patients with selective subtypes of advanced soft-tissue sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo) adjuvant therapy.
Maltese: Votrient huwa indikat għall-kura ta' pazjenti adulti b'sottotipi selettivi ta' sarkoma tat-tessut l-artab (STS) avanzata li rċevew kimoterapija minn qabel għall-marda metastatika jew li kellhom progressjoni fi żmien 12-il xahar wara terapija (neo) awżiljarja.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Votrient in all subsets of the paediatric population in treatment of kidney and renal pelvis carcinoma (excluding nephroblastoma, nephroblastomatosis, clear cell sarcoma, mesoblastic nephroma, renal medullary carcinoma and rhabdoid tumour of the kidney) (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini rrinunzjat għall-obbligu li jiġu ppreżentati r-riżultati tal-istudji b'Votrient f'kull sett tal-popolazzjoni pedjatrika fil-kura ta' karċinoma tal-kilwa u tal-pelvi tal-kilwa (minbarra nefroblastoma, nefroblastomatosi, sarkoma taċ-ċellula ċara, nefroma mesoblastika, karċinoma tal-medulla tal-kilwa u tumur rabdojd tal-kilwa) (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Each Votrient 400 mg film-coated tablet contains 400 mg pazopanib.
Maltese: - Kull pillola miksija b'rita ta' Votrient 400 mg fiha 400 mg pazopanib.
English: Posterior reversible encephalopathy / reversible posterior leukoencephalopathy syndrome†
Maltese: Enċefalopatija posterjuri riversibbli/sindrome tallewkoenċefalopatija posterjuri riversibbli†
English: Signs and symptoms may include: - bruising easily - high blood pressure - fever - confusion - drowsiness - seizures (fits) - decrease in urine output
Maltese: - titbenġel faċilment - pressjoni għolja tad-demm - deni - konfużjoni - ngħas - puplesiji (attakki) - tnaqqis fil-produzzjoni tal-awrina
English: Liver test values
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Neutropenia, thrombocytopenia and palmar-plantar erythrodysaethesia syndrome were observed more frequently in patients of East Asian descent.
Maltese: Newtropenja, tromboċitopenja u sindromu ta' palmar-plantar erythrodysaethesia ġew osservati b'mod aktar frekwenti f'pazjenti ta' dixxedenza tal-Asja tal-Lvant.
English: Pruritus
Maltese: Riżultat
English: Daily dosing results in 1.23- to 4-fold increase in AUC0-T.
Maltese: L-għoti ripetut ta' dożi kuljum irriżulta f'żieda ta' bejn 1.23- għal 4-darbiet fl-AUC0-T.
English: A reduced pazopanib dose of 200 mg once daily is recommended in patients with moderate hepatic impairment (elevation of bilirubin >1.5 to 3 x ULN regardless of the ALT value) (see sections 4.2 and 5.2).
Maltese: Doża mnaqqsa ta' pazopanib ta' 200 mg darba kuljum hija rrakkomandata f'pazjenti b'indeboliment epatiku moderat (elevazzjoni ta' bilirubin >1.5 sa 3 x ULN indipendenti mill-valur tal-ALT)
English: In clinical studies with pazopanib in advanced soft tissue sarcoma, events of pneumothorax have occurred (see section 4.8).
Maltese: Fi studji kliniċi b'pazopanib dwar sarkoma avanzata tat-tessut l-artab, seħħew avvenimenti ta' pnewmotorax (ara sezzjoni 4.8).
English: Therefore, activity of pazopanib is mainly dependent on parent pazopanib exposure.
Maltese: Għalhekk, l-attività ta' pazopanib hija dipendenti primarjament fuq l-esponiment lejn il-pazopanib innifsu.
English: Ischaemic stroke
Maltese: TAGĦRIF
English: Haematemesis
Maltese: Ipotirojdiżmu
English: Capsule-shaped, white, film-coated tablet with GS UHL debossed on one side.
Maltese: Pillola miksija b'rita, forma ta' kapsula, roża, b' GS JT imnaqqxa fuq naħa waħda.
English: Common Gingival infection 4 (1%)
Maltese: Infezzjoni fil-ħanek 4 (1%) 0
English: Infections and Infestations
Maltese: Infezzjonijiet u infestazzjonijiet
English: Adipocytic sarcoma (all subtypes), all rhabdomyosarcoma that were not alveolar or pleomorphic, chondrosarcoma, osteosarcoma, Ewing tumours/primitive neuroectodermal tumours (PNET), GIST, dermofibromatosis sarcoma protuberans, inflammatory myofibroblastic sarcoma, malignant mesothelioma and mixed mesodermal tumours of the uterus.
Maltese: Sarkoma adipoċitika (sottotipi kollha), kull rabdomijosarkoma li ma kinux alveolari jew plejomorfiċi, kondrosarkoma, osteosarkoma, tumuri ta' Ewing/tumuri primittivi newroektodermali (PNET), GIST, sarkoma dermofibromatosi protuberans, sarkoma infjammatorja mijofibroblastika, mesoteljoma malinna u tumuri mesodermali mħallta tal-utru.
English: A synthetic intermediate in manufacture of pazopanib, which is also present in the final drug substance in low amounts, was not mutagenic in the Ames assay but genotoxic in the mouse lymphoma assay and in vivo mouse micronucleus assay.
Maltese: Intermedjarju sintetiku fil-manifattura ta' pazopanib, li huwa wkoll preżenti fis-sustanza finali taddroga f'ammonti żgħar, ma kienx mutaġeniku fl-assaġġ Ames imma kien ġenotossiku fl-assaġġ tallimfoma tal-ġurdien u fl-assaġġ in vivo tal-mikronukleju tal-ġurdien.
English: Severe
Maltese: Eritema
English: Hepatotoxicity
Maltese: Ipofosfatemija
English: Figure 2 Kaplan-Meier curve for progression-free survival by independent assessment for the treatment-naïve population (VEG105192)
Maltese: Kaplan-Meier għas-sopravivvenza ħielsa mill-progressjoni b'assesjar indipendenti għall- populazzjoni li ma ħadu ebda trattament minn qabel (VEG105192)
English: Deep vein thrombosis (DVT) and pulmonary embolism Votrient may cause blood clots in your veins, especially in your legs (deep vein thrombosis or DVT), which may also travel to your lungs (pulmonary embolism).
Maltese: Trombożi profonda tal-vini (Deep vein thrombosis - DVT) u emboliżmu pulmonari Votrient jista' jikkawża emboli tad-demm fil-vini tiegħek, speċjalment f'riġlejk (trombożi profonda tal-vini jew DVT), li jistgħu wkoll jaslu sal-pulmun tiegħek (emboliżmu pulmonari).
English: Common side effects (may affect up to 1 in 10 people): - indigestion, bloating, flatulence - nose bleed - dry mouth or mouth ulcers - infections - abnormal drowsiness - difficulty sleeping - chest pain, shortness of breath, leg pain, and swelling of the legs/feet.
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa 1 minn kull 10 persuni): - indiġestjoni, distenzjoni, gass - fsada fl-imnieħer - ħalq xott jew ulċeri fil-ħalq - infezzjonijiet - ħedla abnormali - diffikultà biex torqod - uġigħ fis-sider, qtugħ ta' nifs, uġigħ fir-riġlejn, u nefħa fir-riġlejn/saqajn.
English: Fatal perforation events have occurred.
Maltese: Kien hemm każi fejn seħħew avvenimenti ta' perforazzjoni fatali.
English: Uncommon Vaginal haemorrhage 3 (<1%) Menorrhagia
Maltese: Emorraġija fil-vaġina 3 (<1%)
English: These include: - clarithromycin, ketoconazole, itraconazole, rifamicin, telithromycin, voriconazzole (used to treat infection).
Maltese: Dawn jinkludu: - clarithromycin, ketoconazole, itraconazole, rifampicin, telithromycin, voriconazole (użati għal kura tal-infezzjonijiet). - atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (użati għall-kura tal-HIV). - nefazodone (użati għall-kura tad-depressjoni). - simvastatin u possibilment statins oħra (użati biex jikkuraw livelli għolja ta' kolesterol). - mediċini li jnaqqsu l-aċidu fl-istonku.
English: Pazopanib should be used with caution in patients who are at increased risk of thrombotic events or who have had a history of thrombotic events.
Maltese: Pazopanib għandu jintuża b'kawtela f'pazjenti li għandhom riskju akbar ta' avvenimenti trombotiċi jew li kellhom storja ta' avvenimenti trombotiċi.
English: Hypothyroidism
Maltese: Immaniġġar
English: Median (weeks)
Maltese: Medjan (xhur)
English: Based on the diminished exposure and limited hepatic reserve pazopanib is not recommended in patients with severe hepatic impairment (defined as total bilirubin >3 X ULN regardless of any level of ALT) (see section 4.2).
Maltese: Ibbażat fuq esponiment imnaqqas u riserva epatika limitata pazopanib mhux irrakkomandat f'pazjenti b'indeboliment epatiku sever (definit bħala bilirubin totali >3 X ULN indipendenti minn kwalunkwe livell ta' ALT) (ara sezzjoni 4.2).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikati fuq ilportal elettroniku Ewropew tal-mediċini.
English: Dosing recommendations in hepatically impaired patients are based on pharmacokinetic studies of pazopanib in patients with varying degrees of hepatic dysfunction (see section 5.2).
Maltese: Rakkomandazzjonijiet għad-dożi f'pazjenti b'indeboliment tal-fwied huma bbażati fuq studji farmakokinetiċi ta' pazopanib f'pazjenti bi gradi differenti ta' disfunzjoni tal-fwied (ara sezzjoni 5.2).
English: In clinical studies with pazopanib, events of GI perforation or fistula have occurred (see section 4.8).
Maltese: Fi studji kliniċi b'pazopanib, kienu seħħew avvenimenti ta' perforazzjoni GI jew fistula (ara sezzjoni 4.8).
English: Concomitant use of pazopanib with a strong CYP3A4 inhibitor should be avoided (see section 4.4).
Maltese: Użu ta' pazopanib flimkien ma' inibitur qawwi ta' CYP3A4 għandu jiġi evitat (ara sezzjoni 4.4).
English: Votrient can increase your likelihood of having a stroke.
Maltese: Votrient jista' jżid il-probabbiltà tiegħek li jkollok puplesija.
English: Since vascular endothelial growth factor (VEGF) inhibitors may impair wound healing, treatment with pazopanib should be stopped at least 7 days prior to scheduled surgery.
Maltese: Minħabba li inibituri tal-fattur tal-iżvilupp tal-endotilju vaskulari (vascular endothelial growth factor - VEGF) jistgħu jxekklu lfejqan ta' feriti, trattament b'pazopanib għandu jitwaqqaf ta' lanqas sebat ijiem qabel il-kirurġija skedata.
English: When using pazopanib, baseline and periodic monitoring of electrocardiograms and maintenance of electrolytes (e.g. calcium, magnesium, potassium) within normal range is recommended.
Maltese: Waqt l-użu tal-pazopanib, linja bażi u monitoraġġ perjodiku ta' elettrokardjogrammi u ż-żamma ta' elettroliti eż. kalċjum, maneżju, potassjum) f'livelli normali huwa rakkomandat.
English: Uncommon Rhinorrhoea Pulmonary haemorrhage
Maltese: Inċident ċerebrovaskulari Puplesija iskemika
English: Elimination is primarily via faeces with renal elimination accounting for <4% of the administered dose.
Maltese: L-eliminazzjoni hija prinċipalment mal-ippurgar b'eliminazzjoni renali li tammonta għal <4% tad-doża amministrata.
English: Changes in heart rhythm (QT prolongation)
Maltese: Tibdil fir-ritmu tal-qalb (titwil tal-QT)
English: Elderly
Maltese: Adulti
English: Hepatobiliary disorders
Maltese: Depigmentazzjoni talġilda
English: Figure 1 Kaplan-Meier curve for progression-free survival by independent assessment for the overall population (treatment-naïve and cytokine pre-treated populations) (VEG105192)
Maltese: Kaplan-Meier għas-sopravivvenza ħielsa mill-progressjoni b'assesjar indipendenti għall-populazzjoni ġenerali (populazzjonijiet li ma ħadu ebda trattament minn qabel u dawk li ħadu trattament minn qabel b'ċitokini) (VEG105192)
English: Pregnancy/ Contraception in males and females
Maltese: Tqala/Kontraċezzjoni fl-irġiel u n-nisa
English: TMA has been reported in clinical studies of pazopanib as monotherapy, in combination with bevacizumab, and in combination with topotecan (see section 4.8).
Maltese: TMA Thrombotic microangiopathy kienet irrappurtata fi studji kliniċi ta' pazopanib bħala monoterapija, flimkien ma' bevacizumab, u flimkien ma' topotecan (ara sezzjoni 4.8).
English: In a pharmacogenetic meta-analysis of data from 31 clinical studies of pazopanib administered either as monotherapy or in combination with other agents, ALT >5 x ULN (NCI CTC Grade 3) occurred in 19% of HLA-B*57:01 allele carriers and in 10% of non-carriers.
Maltese: Grad 3) f'19% tattrasportaturi tal-allel HLA-B*57:01 u f'10% tan-non-trasportaturi.
English: Leiomyosarcoma
Maltese: Sogħla
English: Other key eligibility criteria of the VEG110727 study were: histological evidence of high or intermediate grade malignant STS and disease progression within 6 months of therapy for metastatic disease, or recurrence within 12 months of (neo) -/adjuvant therapy.
Maltese: Kriterji prinċipali ta' eliġibilità oħra kienu: evidenza istoloġika ta' STS malinna ta' grad għolja jew intermedja u progressjoni tal-marda fi żmien 6 xhur wara terapija għall-marda metastatika, jew rikorrenza fi żmien 12-il xahar wara terapija (neo)-/awżiljarja.
English: Uncommon Hypoaesthesia Transient ischaemic attack
Maltese: Mhux komuni Ipoesteżija Attakk iskemiku temporanju
English: HDPE bottles with polypropylene child resistant closures containing either 30 or 90 tablets.
Maltese: Fliexken ta' HDPE b'tapp tal-polypropylene li mhux aċċessibbli għat-tfal, li fihom jew 30 jew 90 pillola.
English: Dysphonia
Maltese: Deidratazzjoni
English: Common Insomnia
Maltese: Insomnija
English: In a Phase II study of 225 patients with locally recurrent or metastatic clear cell renal cell carcinoma, objective response rate was 35% and median duration of response was 68 weeks, as per independent review.
Maltese: II ta' 225 pazjent b'karċinoma lokali rikurrenti jew metastatika taċ-celloli ċari taċ-ċelloli tal-kliewi, ir-rata oġġettiva tar-rispons kien 35% u t-tul taż-żmien medju tar-rispons kien 68 gimgħa, skont eżami independenti.
English: The median steady-state pazopanib Cmax and AUC(0-24) in patients with mild abnormalities in hepatic parameters (defined as either normal bilirubin and any degree of ALT elevation or as an elevation of bilirubin up to 1.5 x ULN regardless of the ALT value) after administration of 800 mg once daily are similar to the median in patients with normal hepatic function (see Table 7).
Maltese: Il-medjan tas-Cmax u l-AUC(0-24) ta' pazopanib fl-istat fiss f'pazjenti b'anormalitajiet ħfief fil-parametri tal-fwied (ddefiniti jew bħala bilirubin normali u kwalunkwe grad ta' żieda fil-livell ta' ALT jew inkella bħala żieda sa 1.5 x l-ULN fil-livell ta' bilirubin ikun xi jkun il-valur tal-ALT) wara għoti ta' 800 mg darba kuljum kien jixbah il-medjan f'pazjenti b'funzjoni normali tal-fwied (ara Tabella 7). 800 mg pazopanib darba kuljum hija d-doża rrakkomandata f'pazjenti b'anormalitajiet ħfief fit-testijiet tas-serum tal-fwied (ara sezzjoni 4.2).
English: Pazopanib has not been studied in patients who had a history of haemoptysis, cerebral haemorrhage or clinically significant gastrointestinal (GI) haemorrhage in the past 6 months.
Maltese: Pazopanib ma ġiex studjat f'pazjenti li kellhom storja ta' emoptezi, emorraġija tal-moħħ jew emorraġiji gastro-intestinali (GI) ta'sinifikat kliniku fl-aħħar sitt xhur.
English: Based on safety and tolerability data, the dose of pazopanib should be reduced to 200 mg once daily in subjects with moderate hepatic impairment (see section 4.2).
Maltese: Fuq bażi ta' dejta dwar is-sigurtà u t-tolerabilità, id-doża ta' pazopanib għandha titnaqqas għal 200 mg darba kuljum f'suġġetti b'indeboliment epatiku moderat (ara sezzjoni 4.2).
English: Uncommon Chills Mucous membrane disorder
Maltese: Mhux komuni Ngħas Parasteżija
English: Mild, indirect (unconjugated) hyperbilirubinaemia may occur in patients with Gilbert's syndrome.
Maltese: Iperbilirubinemija ħafifa u indiretta (mhux konjugata) tista' sseħħ f'pazjenti li jkollhom is-sindrome ta' Gilbert.
English: The primary objective of the study was progression-free survival (PFS assessed by independent radiological review); the secondary endpoints included overall survival (OS), overall response rate and duration of response.
Maltese: L-għan primarju tal-istudju kien sopravivenza mingħajr progressjoni (PFS evalwata minn analiżi radjoloġika indipendenti); il-miri sekondarji kienu jinkludu sopravivenza globali (OS), rata ta' rispons globali u tul ta' rispons.
English: When post-weaning rats were dosed from day 21 post partum to day 62 post partum, toxicological findings were similar to adult rats at comparable exposures.
Maltese: Meta firien wara li nfatmu ingħataw doża minn jum 21 wara t-twelid sa jum 62 wara t-twelid, sejbiet tossikoloġiċi kienu simili għal dawk f'firien adulti b'esponimenti komparabbli.
English: Signs and symptoms of a hypertensive crisis may include: - severe chest pain - severe headache - blurred vision - confusion - nausea - vomiting - severe anxiety - shortness of breath - seizures (fits) - fainting
Maltese: Is-sinjali u s-sintomi ta' kriżi ipertensiva jistgħu jinkludu: - uġigħ sever fis-sider - uġigħ ta' ras qawwi - vista mċajpra - konfużjoni - nawsja - rimettar - ansjetà qawwija - qtugħ ta' nifs - puplesiji (attakki) - ħass ħażin
English: Uncommon Tumour pain
Maltese: Emboli tad-demm
English: Pruritus generalised 2 (<1%) Rash generalised Rash papular
Maltese: Ippurgar frekwenti Emorraġija mill-anus 2 (<1%) Perforazzjoni talmusrana l-kbira
English: In the RCC studies of pazopanib, overall no clinically significant differences in safety of pazopanib were observed between subjects aged at least 65 years and younger subjects.
Maltese: Fl-istudji RCC ta' pazopanib, in ġenerali ma kienu osservati l-ebda differenzi kiliniċi sinifikattivi fis-sigurtà ta' pazopanib bejn suġġetti li kellhom tal-anqas 65 sena u suġġetti iżgħar.
English: In clinical studies with pazopanib, events of cardiac dysfunction such as congestive heart failure and decreased LVEF have occurred (see section 4.8).
Maltese: Fi studji kliniċi b'pazopanib, seħħew avvenimenti ta' disfunzjoni tal-qalb bħal insuffiċjenza tal-qalb konġestiva u LVEF imnaqqas (ara sezzjoni 4.8).
English: For patients who responded to treatment, the median time to response was 11.9 weeks and the median duration of response was 58.7 weeks as per independent review (VEG105192).
Maltese: Għall-pazjenti li rrispondew għat-trattament, iż-żmien medju għal rispons kien 11.9-il ġimgħa u t-tul taż-żmien medju tar-respons kien 58.7 ġimgħat skont eżami indipendenti (VEG105192).
English: Co-administration of pazopanib with a CYP3A4, P-gp, and BCRP inhibitor, such as lapatinib, will result in an increase in plasma pazopanib concentrations.
Maltese: L-għoti ta' pazopanib flimkien ma' inibitur ta' CYP3A4, P-gp, u BCRP, bħal lapatinib, jirriżulta f'żieda fil-konċentrazzjoni tal-pazopanib fil-plażma.
English: †Treatment-related adverse reaction reported during post-marketing period (spontaneous case reports and serious adverse reactions from all pazopanib clinical studies).
Maltese: †Reazzjoni avversa relatata mal-kura rrappurtata waqt il-perjodu ta' wara t-tqegħid fis-suq (rapporti ta' każijiet spontanji u reazzjonijiet avversi serji mill-istudji kliniċi kollha ta' pazopanib).
English: There was no consistent increase in AUC or Cmax at pazopanib doses above 800 mg.
Maltese: Ma kien hemm l-ebda żieda konsistenti fil-AUC jew Cmax b'dożi ta'pazopanib ‘il fuq minn 800 mg.
English: Decreased appetite and anorexia f Cardiac dysfunction, left ventricular dysfunction, cardiac failure and restrictive cardiomyopathy g
Maltese: g Avvenimenti ta' disfunzjoni tal-qalb - jinkludu Disfunzjoni tal-ventriklu tax-xellug, Insuffiċjenza tal-qalb u Kardjomijopatija restrittiva h
English: OD - once daily
Maltese: OD - darba kuljum
English: Rash pruritic
Maltese: Emorraġija mirrektum
English: Combination with strong P-gp or BCRP inhibitors should be avoided, or selection of an alternate concomitant medicinal product with no or minimal potential to inhibit P-gp or BCRP is recommended.
Maltese: Taħlit ma'inibituri potenti ta' P-gp jew BCRP għandu jiġi evitat, jew għandha tiġi rrakkomandata lgħażla ta' prodott mediċinali ieħor li jingħata flimkien bla ebda effett jew bi potenzjal minimu li jimpedixxi l-P-gp jew l-BCRP.
English: Adverse drug reactions, all grades, which were reported in RCC and STS subjects or during the post-marketing period are listed below by MedDRA body system organ class, frequency and grade of severity.
Maltese: Reazzjonijiet avversi ta' kull grad għall-mediċina, li kienu rrappurtati f'individwi b'RCC u STS jew waqt il-perijodu ta' wara t-tqegħid fis-suq huma elenkati hawn taħt skond is-sistema ta' klassifika talorgani MedDRA, il-frekwenza u l-grad ta' severità.
English: Votrient 400 mg film-coated tablets
Maltese: Votrient 400 mg pilloli miksija b'rita
English: Synovial sarcoma subgroups* N = 25
Maltese: Sottogruppi ta' sarkoma sinovjali*
English: Oesophageal haemorrhage
Maltese: Uġigħ muskoluskeletrali
English: HDPE bottles with polypropylene child resistant closures containing either 30 or 60 tablets.
Maltese: Fliexken ta' HDPE b'tapp tal-polypropylene li mhux aċċessibbli għat-tfal, li fihom jew 30 jew 60 pillola.
English: Very common Dysgeusia c
Maltese: Komuni ħafna Disġewżja c
English: Administration of a pazopanib 400 mg crushed tablet increased AUC(0-72) by 46% and Cmax by approximately 2 fold and decreased tmax by approximately 2 hours compared to administration of the whole tablet.
Maltese: L-għotja ta' 400 mg Pazopanib bħala pillola mfarrka żied l-AUC(0-72) b'46% u c-Cmax b'madwar 2-tejn iżjed u naqqas t-tmax b'madwar sagħtejn meta mqabbel mal-għoti ta' pillola sħiħa.
English: 60 film-coated tablets
Maltese: 60 pillola miksija b'rita
English: 1 pre-rolled matrix of 4.8 cm x 4.8 cm
Maltese: Matriċi 1 rumblata billest ta' 4.8 ċm x 4.8 ċm
English: Pack size
Maltese: Użu lepileżjonali