FrancophonIA/ELRC3.0 huggingface dataset:
English: In a clinical study in healthy volunteers, co-administration of tivozanib with a potent CYP3A4 inhibitor, ketoconazole (400 mg once daily), had no influence on tivozanib serum concentrations (Cmax or AUC); therefore, tivozanib exposure is unlikely to be altered by CYP3A4 inhibitors.
Maltese: Fi studju kliniku f'voluntiera b'saħħithom, il-koamministrazzjoni ta' tivozanib ma' inibitur qawwi ta' CYP3A4, ketoconazole (400 mg darba kuljum), ma kellu l-ebda influwenza fuq il-konċentrazzjonijiet fis-serum ta' tivozanib (Cmax jew AUC); Għalhekk, l-espożizzjoni ta' tivozanib mhux probabbli li jinbidel minn impedituri CYP3A4.
English: (E171), tartrazine aluminium lake (E102).
Maltese: diossidu tat-titanju (E171), tartrazine aluminium lake (E102).
English: For patients who develop Grade 2 (> 1.0-3.4 g/24 hours) or Grade 3 (≥ 3.5 g/24 hours) proteinuria (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE]), the dose of tivozanib has to be reduced or the treatment temporarily interrupted.
Maltese: Għal pazjenti li jiżviluppaw Grad 2 (> 1.0-3.4g/24 siegħa) jew Grad 3 (≥ 3.5g/24 siegħa) ta' proteina fl-awrina (Kriterji ta' Terminoloġija Komuni għal Avvenimenti Avversi tal-Istitut Nazzjonali tal-Kankru [NCI CTCAE]), id-doża ta' tivozanib għandha titnaqqas jew il-kura għandha tiġi interotta temporanjament.
English: In studies that evaluated the terminal elimination phase, tivozanib had a mean t½ of 4.5 - 5.1 days.
Maltese: Fi studji li evalwaw il-fażi ta' eliminazzjoni terminali, tivozanib kellu medja ta' t½ ta' 4.5 5.1 jiem.
English: In clinical studies with tivozanib, QT/QTc interval prolongation has been reported (see section 4.8 and section 5.1).
Maltese: Fi studji kliniċi b'tivozanib, ġie rrappurtat titwil fl-intervall QT/QTc (ara sezzjoni 4.8 u sezzjoni 5.1).
English: Table 2: Efficacy analysis by independent radiology review (ITT population)
Maltese: Tabella 2: Analiżi effikaċja minn reviżjoni ta' radjoloġija indipendenti (ITT popolazzjoni) Tivozanib
English: Rare (may affect up to 1 in 1,000 people)
Maltese: Rari (jistgħu jaffettwaw sa persuna 1 minn kull 1,000 persuna)
English: In clinical studies with tivozanib, venous thromboembolic events (VTEs) have been reported including pulmonary embolism and deep vein thrombosis (see section 4.8).
Maltese: Fi studji kliniċi b'tivozanib, episodji tromboemboliċi venużi (VTEs) kienu rrappurtati inkluż l-emboliżmu pulmonari u trombożi tal-vini profondi (ara sezzjoni 4.8).
English: In vitro studies have shown that tivozanib is neither a substrate nor inhibitor of the transporter proteins MDR1 (P-gp), OCT1, OATP1B1, OATP1B3 and BSEP.
Maltese: MDR1 (P-gp), OCT1, OATP1B1, OATP1B3 u BSEP.
English: Reproduction, mutagenesis, impairment of fertility Tivozanib may impair human fertility.
Maltese: Riproduzzjoni, mutaġenesi, indeboliment fil-fertilità Tivozanib jista' jġarrab ħsara fil-fertilità tal-bniedem.
English: 0.520e a Hazard ratio for tivozanib arm vs. sorafenib arm, based on stratified Cox proportional hazards model.
Maltese: 0.520e a Proporzjon ta' periklu għal grupp tivozanib vs. grupp sorafenib, ibbażata fuq mudell ta' proporzjon ta' periklu fuq Cox stratifikat.
English: EUSA Pharma (Netherlands) B.V.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq EUSA Pharma (Netherlands) B.V.
English: 2D barcode carrying the unique identifier included.
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D barcode 2D li jkollu l-identifikatur uniku inkluż
English: Hypertension Haemorrhage9
Maltese: Emorraġija9
English: Alternatively, a statin not subject to restriction of intestinal absorption by BCRP should be considered.
Maltese: Alternattivament, statin mhux suġġetti għal restrizzjoni tal-assorbiment intestinali minn BCRP għandha tiġi kkunsidrata.
English: No concentration dependence of plasma protein binding was observed over the range of 0.1 to 5 µmol/L tivozanib.
Maltese: Ma kienet osservata l-ebda dipendenza fil-konċentrazzjoni tal-irbit mal-proteina fil-plażma fuq medda ta' 0.1-5 μmol/l ta' tivozanib.
English: Printing ink (yellow) Shellac
Maltese: Linka tal-istampar (isfar) Shellac
English: No significant increase in exposure was observed in patients with mild (Child-Pugh Class A) hepatic impairment (mean AUC0-∞ by 1.2-fold).
Maltese: Ma kienx osservat l-ebda żieda sinifikanti fl-espożizzjoni f'pazjenti b'indeboliment epatiku ħafif (Child-Pugh Klassi A) (AUC0 ∞ b'1.2 darbiet).
English: In a controlled clinical study (AV-951-09-301), in which 25% of patients receiving tivozanib were ≥ 65 years of age, no overall differences was observed in efficacy between elderly and younger patients (see section 4.2).
Maltese: Fi studju kliniku kkontrollat (AV 951 09 301), li fiha 25% tal-pazjenti li rċevew tivozanib kellhom ≥ 65 sena, l-ebda differenzi globali ma kienu osservati fl-effikaċja bejn pazjenti anzjani u dawk iżgħar (ara sezzjoni 4.2).
English: The baseline demographic and disease characteristics were generally well balanced across the tivozanib and sorafenib arms with regard to age (mean age 58.2 vs 58.4 years respectively), gender (71.2% vs 73.5% male respectively), race (95.8% vs 96.9% white respectively), geographic region (88.1% vs 88.7% from Central/Eastern Europe respectively) and prior treatment for metastatic RCC (69.6% vs 70.8% treatment naïve respectively).
Maltese: 8% vs 96.9% kawkażi rispettivament), reġjun ġeografiku (88.1% vs 88.7% minn Ewropa Ċentrali/Lvant rispettivament) u t-trattament minn qabel għal RCC metastatiku (69.6% vs 70.8% li qatt ma rċevew trattament rispettivament).
English: In the five core RCC monotherapy studies tivozanib was discontinued in a total of 20 patients (3%) owing to adverse reactions, most commonly due to hypertension (0.4%), persistent severe hypertension (0.3%), or acute myocardial infarction (0.3%).
Maltese: Fil-ħames studji ewlenin tal-monoterapija RCC tivozanib twaqqfet f'total ta' 20 pazjent (3%) minħabba reazzjonijiet avversi, aktar komuni minħabba pressjoni għolja (0.4%), pressjoni għolja severa persistenti (0.3%), jew infart mijokardijaku akut (0.3% ).
English: Risk factors for ATE include malignant disease, age > 65 years, hypertension, diabetes mellitus, smoking, hypercholesterolaemia, and prior thromboembolic disease.
Maltese: Fatturi ta' riskju għal ATE jinkludu mard malinn, ta' età> 65 sena, pressjoni għolja, dijabete mellitus, tipjip, iperkolesterolimja, u mard tromboemboliku minn qabel.
English: Abdominal pain15 Nausea Diarrhoea Stomatitis16
Maltese: Dijarea Stomatite16
English: • Tiredness and lack of energy.
Maltese: • Għeja u nuqqas ta' enerġija.
English: For the 30% of patients receiving prior treatment, the predominant therapy was interferon alpha as monotherapy which was received by 75 patients in the tivozanib arm and 62 patients in the sorafenib arm.
Maltese: Għall-30% tal-pazjenti li jirċievu trattament minn qabel, it-terapija predominanti kienet b'interferon alfa bħala monoterapija li ġiet mogħtija lill-75 pazjenti fil-grupp tivozanib u 62 pazjent fil-grupp sorafenib.
English: • Abnormal electrocardiogram (ECG), rapid and/or irregular heart beat.
Maltese: • Elettrokardjogramm anormali (ECG), taħbit tal-qalb mgħaġġel u/jew irregolari
English: Stratification factors are number of prior treatments (0 or 1) and number of metastatic sites/organs involved (1 or ≥2).
Maltese: Fatturi ta' stratifikazzjoni huma numru ta' trattamenti minn qabel (0 jew 1) u numru ta' siti metastatiċi/organi nvoluti (1 jew ≥2).
English: Titanium dioxide (E171) Indigo carmine (E132) Yellow iron oxide (E172)
Maltese: Diossidu tat-titanju (E171) Indigo carmine (E132) Ossidu tal-ħadid isfar (E172)
English: After a single dose oral dose of [14C] tivozanib, approximately 79% of the radioactivity was recovered in the faeces and approximately 12% was found in the urine as metabolites.
Maltese: Wara doża waħda ta' doża orali ta' [14C] tivozanib, madwar 79% tar-radjuattività kienet irkuprata fl-ippurgar u madwar 12% instab fl-awrina bħala metaboliti.
English: Haemorrhage adverse reactions were reported in the core monotherapy studies during initial treatment (see section 4.4).
Maltese: Ġew irrappurtati reazzjonijiet avversi ta' emorraġija fl-istudji ewlenin tal-monoterapija waqt it-trattament inizjali (ara sezzjoni 4.4).
English: The occurrence of undesirable effects may require temporary interruption and/or dose reduction of tivozanib therapy (see section 4.4).
Maltese: L-okkorrenza ta' effetti mhux mixtieqa jistgħu jeħtieġu interruzzjoni temporanja u/jew tnaqqis fid-doża ta' terapija b'tivozanib (ara sezzjoni 4.4).
English: Herbal preparations containing St. John's wort (Hypericum perforatum) are contraindicated.
Maltese: John 's wort (Hypericum perforatum) huma kontraindikati.
English: The primary endpoint of the study was progression-free survival (PFS) by blinded independent radiology review; key secondary endpoints included overall survival (OS) and objective response rate (ORR) by independent radiology review.
Maltese: Il-mira primarja tal-istudju kienet sopravivenza mingħajr progressjoni (PFS) minn reviżjoni ta' radjoloġija indipendenti mgħammda; miri sekondarji ewlenin inkludew sopravivenza totali (OS) u rata ta' rispons oġġettiv (ORR) permezz ta' reviżjoni ta' radjoloġija indipendenti.
English: In the ITT population there was a small numerical difference between the two arms in terms of overall survival.
Maltese: Fil-popolazzjoni ITT kien hemm differenza numerika żgħira bejn iż-żewġ gruppi f'termini ta' sopravivenza globali.
English: Most events in the five renal cell carcinoma monotherapy studies were CTC Grade 1 or 2 (≥ CTC Grade 3 was observed in < 2% of patients treated with tivozanib) and there were no serious events (see section 4.8).
Maltese: Grad 3 kienet osservata f ' <2% tal-pazjenti kkurati b'tivozanib) u ma kienx hemm avvenimenti serji (ara sezzjoni 4.8).
English: Moderate CYP3A4 inducers are not expected to have a clinically relevant effect on tivozanib exposure.
Maltese: Indutturi moderati ta' CYP3A4 mhumiex mistennija li jkollhom effett klinikament rilevanti fuq l-espożizzjoni ta' tivozanib.
English: Fotivda 890 microgram hard capsules have a dark blue opaque cap and bright yellow opaque body, printed with yellow ink “TIVZ” on the cap and with dark blue ink “LD” on the body.
Maltese: Fotivda 890 mikrogramma kapsuli iebsin għandhom tapp opak blu skur u korp opak isfar jgħajjat, stampat b'linka safra “TIVZ” fuq it-tapp u b'linka blu skura “LD” fuq il-korp.
English: Thrombocytopenia Haemoglobin increased
Maltese: Żieda fil-emoglobina
English: haemorrhagic stroke, mouth haemorrhage, pulmonary haemorrhage and respiratory tract haemorrhage 10 Arterial thromboembolism including acute myocardial infarction, arterial thrombosis, iliac artery thrombosis,
Maltese: 10 Tromboemboliżmu arterjali inkluż infart mijokardijaku akut, trombożi arterjali, trombożi tal-arterja tal-ilju, puplesija iskemika, infart mijokardijaku u attakk iskemiku temporanju
English: How to store Fotivda
Maltese: X'fih Fotivda
English: All patients should have liver function tests evaluated, including aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, and alkaline phosphatase (AP), to determine hepatic function before starting and during treatment with tivozanib.
Maltese: Il-pazjenti kollha għandhom ikollhom testijiet tal-funzjoni tal-fwied evalwati, inkluż aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, u alkaline phosphatase (AP), biex tiddetermina l-funzjoni tal-fwied qabel ma tibda u waqt il-kura b'tivozanib.
English: - Capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132), yellow iron oxide
Maltese: - Qoxra tal-kapsula: ġelatina, diossidu tat-titanju (E171), indigo carmine (E132), ossidu tal-ħadid isfar (E172).
English: QT prolongation was reported in two patients (CTC Grade 2 and Grade 3) in the tivozanib cardiac safety study, neither reaction was considered serious (see section 4.4 and section 5.1).
Maltese: Ġiet irrappurtata titwil fil-QT f'żewġ pazjenti (CTC Grad 2 u grad 3) fl-istudju kardijaku ta' sigurtà ta' tivozanib, l-ebda reazzjoni ma kienet ikkunsidrata serja (ara sezzjoni 4.4 u sezzjoni 5.1).
English: QT/QTc interval prolongation may lead to an increased risk for ventricular arrhythmias.
Maltese: Titwil fl-intervall QT/QTc jista' jwassal għal riskju akbar għal arritmiji ventrikulari.
English: Other medicines and Fotivda
Maltese: Mediċini oħra u Fotivda
English: 24 Rash including rash, rash erythematous, rash generalised, rash maculo-papular, rash papular and rash pruritic 25 Acne including acne and dermatitis acneiform26 Dermatitis including dermatitis and dermatitis bullous
Maltese: Raxx inkluż raxx, raxx eritumatuż, raxx ġeneralizzat, raxx makulo-papulari, raxx papulari , raxx minħabba ħakk tal-ġilda
English: No adverse reaction was experienced by the second patient who took 2 doses of 1340 microgram tivozanib in one day (total 2680 microgram).
Maltese: L-ebda reazzjoni avversa ma kienet esperjenzata mit-tieni pazjent li ħa 2 dożi ta' 1340 mikrogramma tivozanib f'jum wieħed (total 2680 mikrogramma).
English: In female rats, an increase in non-viable foetuses was noted at a dose 0.7-fold the recommended clinical dose, while dose levels ≥ 2 fold the recommended clinical dose produced infertility.
Maltese: Fil-firien nisa, żieda fil-feti mhux vijabbli ġie nnotat f'doża ta' 0.7 darbiet id-doża klinika rakkomandata, filwaqt li livelli tad-doża ≥ darbtejn id-doża klinika rakkomandata pproduċiet infertilità.
English: In clinical studies with tivozanib, hand foot skin reaction (palmar-plantar erythrodysaesthesia) has been reported.
Maltese: Fi studji kliniċi b'tivozanib, ġie irrappurtat reazzjoni tal-ġilda fl-idejn u s-saqajn (eritrodisasteżija palmari-plantari).
English: The central tendency change for all measured days and across all time points was 2.2 ms. No subjects had a new > 500 ms change in QTcF; 2 patients (4%) had QTcF values > 480 ms. One subject (2%) had a > 60 ms change from baseline in QTcF and 6 subjects (12%) had a 30 ms to 60 ms change from baseline (see section 4.4 and section 4.8).
Maltese: > 60 ms mill-linja bażi fil-QTcF u 6 suġġetti (12%) kellhom bidla minn 30 ms għal 60 ms mill-linja bażi (ara sezzjoni 4.4 u sezzjoni 4.8).
English: Fotivda 890 microgram hard capsules Fotivda 1340 microgram hard capsules
Maltese: Fotivda 890 mikrogramma kapsuli iebsin Fotivda 1340 mikrogramma kapsuli iebsin
English: Albumin is the major tivozanib binding component in human plasma.
Maltese: L-albumina hija l-komponent ta' tivozanib ewlieni li jorbot fil-plażma uman.
English: Contraindication of concomitant use
Maltese: Kontraindikazzjoni ta' użu konkomittanti
English: ischaemic stroke, myocardial infarction and transient ischaemic attack 11 Venous thromboembolism including deep vein thrombosis, embolism venous and pulmonary embolism 12 Persistent severe hypertension including hypertensive crisis 13 Flushing including flushing and hot flush
Maltese: 11 Tromboemboliżmu tal-vini inkluż trombożi tal-vini fondi, emboliżmu vaskulari u emboliżmu pulmonari 12 Pressjoni għolja severa persistenti inkluż kriżi ipertensiva 13 Fwawar inkluż fwawar u fwawar tal-menopawża
English: QT interval prolongation
Maltese: Titwil fl-intervall QT
English: In vitro studies have shown that tivozanib is neither a substrate nor an inhibitor of the multidrug efflux pump, P-glycoprotein.
Maltese: Studji in vitro wrew li tivozanib la huwa sottostrat u lanqas inibitur tal-pompa ta' effluss multidrogali, P-glikoproteina.
English: Tivozanib should not be used in patients with severe hepatic impairment (see section 4.2 and section 4.4).
Maltese: Tivozanib m'għandux jintuża f'pazjenti b'indeboliment epatiku sever (ara sezzjoni 4.2 u sezzjoni 4.4).
English: Fotivda 1340 microgram hard capsules tivozanib
Maltese: Fotivda 1340 mikrogramma kapsuli iebsin tivozanib
English: Tivozanib exposure was increased in patients with severe hepatic impairment (mean AUC0-∞ by 4.0-fold) and in patients with moderate hepatic impairment (mean AUC0-∞ by 2.6-fold).
Maltese: L-espożizzjoni ta' tivozanib żdiedet f'pazjenti b'indeboliment epatiku sever (AUC0 ∞ b'4.0 darbiet) u f'pazjenti b'indeboliment epatiku moderat (AUC0 ∞ b'2.6 darbiet).
English: In a cardiac safety study of 50 patients with advanced solid tumours treated with tivozanib at 1340 microgram daily for 21 days, the mean change from baseline in QTcF was 6.8 ms on day 21 of dosing.
Maltese: Fi studju ta' sigurtà kardijaku ta' 50 pazjent b'tumuri solidi avanzati kkurati b'tivozanib ta' 1340 mikrogramma kuljum għal 21 jum, il-bidla medja mill-linja bażi fil-QTcF kienet 6.8 ms fil-21 jum tad-dożaġġ.
English: After once daily dosing of 1340 microgram tivozanib for 21 or 28 days in RCC patients, Cmax was 67.5 to 94.3 ng/mL and AUC0-24 was 1,180 to 1,641 ng.hr/mL.
Maltese: Doża waħda AUC0-inf għal voluntiera b'saħħithom li ngħataw doża ta' 1340 mikrogramma tivozanib kienet 1950 sa 2491 ng.hr/ml. Wara dożaġġ ta' darba kuljum ta' 1340 mikrogramma tivozanib għal 21 jew 28 jum f'pazjenti b'RCC, Cmax kienet 67.5-94.3 ng/ml u AUC0-24 kien 1180 sa 1641 ng.hr/ml.
English: Dysphonia, diarrhoea, fatigue, weight decreased, appetite decreased and hypothyroidism occurred more commonly in patients ≥ 65 years of age.
Maltese: Disfonja, dijarea, għeja, tnaqqis fil-piż, nuqqas t'aptit u ipotirojdiżmu seħħew l-aktar komuni f'pazjenti ≥ 65 sena.
English: Tivozanib
Maltese: Tartrazine
English: White HDPE bottle with a child resistant closure containing 21 hard capsules.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 21 kapsula iebsa.
English: After a single 1340 microgram dose, mean Cmax was 10.2 to 25.2 ng/mL across healthy subject and patient studies.
Maltese: Wara doża waħda ta' 1340 mikrogramma, il-medja Cmax kienet 10.2 sa 25.
English: In clinical studies with tivozanib, elevations of ALT, AST, and bilirubin have been reported (see section 4.8).
Maltese: Fi studji kliniċi b'tivozanib, ġew irrappurtati elevazzjonijiet ta' ALT, AST, u bilirubin (ara sezzjoni 4.8).
English: A patient with a history of hypertension experienced aggravated uncontrolled hypertension that was fatal after taking 3 doses of 1340 microgram tivozanib in one day (total 4020 microgram).
Maltese: Pazjent bi storja ta' pressjoni għolja ġarrab pressjoni għolja aggravata mhux ikkontrollata li kienet fatali wara li ħa 3 dożi ta' 1340 mikrogramma tivozanib f'jum wieħed (total 4020 mikrogramma).
English: scaling, or peeling, or is stinging or tingling
Maltese: 3 Disgewżja inkluż agewżja, disgewżja u ipogewżja
English: INSTRUCTIONS ON USE
Maltese: Infjammazzjoni mukożali
English: Based on the in vitro IC50 and in vivo unbound Cmax, tivozanib was unlikely to interact in a clinically relevant manner with active substances that are metabolised by these enzyme pathways.
Maltese: Ibbażat fuq l-IC50 in vitro u in vivo Cmax mhux marbut, tivozanib kien improbabbli li jinteraġixxi b'mod klinikament relevanti ma' sustanzi attivi li huma metabolizzati minn dawn is-sistemi ta' enżimi.
English: • Difficult breathing; shortness of breath during exercise; coughing.
Maltese: • Difficultà biex tieħu nifs; qtugħ ta' nifs waqt l-eżerċizzju; sogħla.
English: Gastrointestinal disorders
Maltese: Disturbi gastro intestinali
English: As CYP1A1 is primarily expressed in extrahepatic tissues such as the lung and intestine, it was considered unlikely that this isoform would be extensively involved in hepatic metabolism.
Maltese: Peress li CYP1A1 huwa espress primarjament f'tessuti ekstraepatiċi bħall-pulmun u musrana, kien ikkunsidrat bħala mhux probabbli li din l-isoforma tkun involuta b'mod estensiv fil-metaboliżmu epatiku.
English: Chest pain28 Chills29 Pyrexia Peripheral oedema
Maltese: Uġigħ fis-sider28 Sirdat29
English: Proteinuria has been reported in clinical studies with tivozanib (see section 4.8).
Maltese: Proteina fl-awrina ġiet irrappurtata fi studji kliniċi b'tivozanib (ara sezzjoni 4.8).
English: This controlled clinical study was a Phase 3 multi-centre, open-label, international, randomised study comparing tivozanib with sorafenib in patients with advanced RCC. Five hundred and seventeen (517) patients with recurrent or metastatic RCC with a clear cell component were randomised (1:1) to receive either tivozanib 1340 microgram once daily on a schedule of 3 weeks on treatment followed by 1 week off (schedule 3/1) or sorafenib 400 mg twice a day.
Maltese: Ħames mija u sbatax (517)-il pazjent b'RCC metastatiku jew rikurrenti jew b'komponent ta' ċellula ċara kienu randomizzati (1: 1) biex jirċievu jew tivozanib 1340 mikrogramma darba kuljum fuq skeda ta' tliet ġimgħat fuq trattament segwit minn ġimgħa off (skeda 3/1) jew sorafenib 400 mikrogramma darbtejn kuljum.
English: Fotivda 1340 microgram hard capsules
Maltese: Fotivda 1340 mikrogramma kapsuli iebsin
English: Fotivda 1340 microgram hard capsules have a bright yellow opaque cap and bright yellow opaque body, printed with dark blue ink “TIVZ” on the cap and with dark blue ink “SD” on the body.
Maltese: Fotivda 1340 mikrogramma kapsuli iebsin għandhom tapp opak isfar jgħajjat u korp opak isfar jgħajjat, stampat b'linka blu skura “TIVZ” fuq it-tapp u b'linka blu skura “SD” fuq il-korp.
English: • Temporary reduced blood flow to the brain.
Maltese: • Fluss tad-demm imnaqqas temporanjament lill-moħħ
English: Results from a single dose study to evaluate the pharmacokinetics, safety and tolerability of tivozanib in subjects with hepatic impairment show that across the entire measurement period, tivozanib was eliminated more slowly in subjects with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment.
Maltese: Riżultati minn studju ta' doża waħda biex jevalwa l-farmakokinetika, is-sigurtà u t-tollerabilità ta' tivozanib f'suġġetti b'indeboliment epatiku juru li madwar il-perjodu tal-kejl kollu, tivozanib kien eliminat aktar bil-mod f'suġġetti b'indeboliment epatiku moderat (Child-Pugh Klassi B) jew sever (Child-Pugh Klassi C).
English: Your doctor will check you regularly, and you will normally continue to take Fotivda as long as it is working, and you do not suffer unacceptable side effects.
Maltese: It-tabib tiegħek ser jeżaminak regolarment, u normalment ser tkompli tieħu Fotivda sakemm qed taħdem, u ma ssofrix effetti sekondarji inaċċettabbli.
English: Electrocardiogram QT prolonged
Maltese: Elettrokardjogramm tat-titwil fil-QT
English: Missed dose
Maltese: Id-doża rakkomandata
English: Treatment with Fotivda may need to be temporarily stopped.
Maltese: It-trattament b'Fotivda jista' jitwaqqaf temporanjament jekk ikun hemm bżonn.
English: • If you are taking St. John's Wort (also known as Hypericum perforatum, a herbal remedy used for treatment of depression and anxiety).
Maltese: John 's Wort (magħruf ukoll bħala Hypericum perforatum, rimedju erbali użat għall-kura ta' depressjoni u ansjetà).
English: Persistent severe hypertension12
Maltese: Pressjoni għolja persistenti12
English: In clinical studies with tivozanib, haemorrhagic events have been reported (see section 4.8).
Maltese: Fi studji kliniċi b'tivozanib, ġew irrapportati avvenimenti emorraġiċi (ara sezzjoni 4.8).
English: • Fever; chest pain; swelling of feet and legs; chills and low body temperature.
Maltese: • Deni; uġigħ fis-sider; nefħa tas-saqajn u r-riġlejn; sirdat u temperatura baxxa tal-ġisem.
English: • Very high blood pressure leading to a stroke; flushed skin.
Maltese: • Pressjoni tad-demm għolja ħafna li twassal għal puplesija; ħmura tal-ġilda.
English: 16 Stomatitis including oral discomfort, oral disorder and stomatitis 17 Pancreatitis including pancreatitis and pancreatitis acute 18 Dysphagia including dysphagia, odynophagia and oropharyngeal pain 19 Glossitis including glossitis and glossodynia
Maltese: 18 Disfaġja inkluż disfaġja, odinofagia u uġigħ orofarinġeali
English: • Peptic ulcer in the small intestines.
Maltese: • Ulċera peptika fl-imsaren iż-żgħar.
English: Each capsule contains tivozanib hydrochloride monohydrate equivalent to 890 microgram of tivozanib.
Maltese: Kull kapsula fiha monoidrat idrokloridu tivozanib ekwivalenti għal 890 mikrogramma ta' tivozanib.
English: Pancreatitis17 Dysphagia18 Vomiting Gastrooesophageal reflux disease Abdominal distension Glossitis19 Gingivitis20 Dyspepsia Constipation Dry mouth Flatulence
Maltese: Fil-każ li wieħed jinsa jieħu doża, m'għandiex tittieħed id-doża li tissostitwixxi dik li nsejt tieħu biex tpatti għad-doża li tkun insejt tieħu.