FrancophonIA/ELRC3.0 huggingface dataset:
English: Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk, CB9 8PU, United Kingdom Or
Maltese: Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk, CB9 8PU, Ir-Renju Unit Jew
English: 52/100 80.4 months a Overall response rate = complete + partial responses.
Maltese: 4 xhur a Rata ta' rispons globali = kompleta + rispons parzjali.
English: Caprelsa comes in blister packs of 30 tablets.
Maltese: Caprelsa jiġi f'pakketti b'folji ta' 30 pillola.
English: Start dose (mg)a
Maltese: Doża tal-bidu (mg)a
English: • Breast-feeding (see section 4.6).
Maltese: • Treddigħ (ara sezzjoni 4.6)
English: Palmar-plantar erythrodysaesthiesia syndrome, alopecia
Maltese: Sindrome palmarplantar eritrodajestisja,
English: OVERALL SURVIVAL N Median OS HRc
Maltese: SOPRAVIVENZA GLOBALI N OS Medjan HRc
English: • Inflammation of the appendix (appendicitis).
Maltese: • Infjammazzjoni tal-appendiċi (appendiċite).
English: A value <1 favors vandetanib.
Maltese: Valur <1 jiffavorixxi vandetanib.
English: Film-coating Hypromellose Macrogol (300) Titanium dioxide (E171)
Maltese: Titanium dioxide (E171)
English: There was no statistically significant difference in final OS (HR 0.99, 95.002% CI 0.72, 1.38, p=0.9750).
Maltese: 002% CI 0.72, 1.38, p=0.9750).
English: • The other ingredients are calcium hydrogen phosphate dihydrate, microcrystalline cellulose,
Maltese: Calcium hydrogen phosphate dihydrate Microcrystalline cellulose Crospovidone,
English: The side effects of Caprelsa are listed in Section 4.
Maltese: L-effetti sekondarji ta' Caprelsa huma elenkati f'Sezzjoni 4.
English: Posterior reversible encephalopathy syndrome, PRES (Reversible posterior leukoencephalopathy syndrome-RPLS)
Maltese: Sindrome ta' enċefalopatija posterjuri riversibbli, PRES (sindrome lewkoenċefalopatika posterjuri riversibli-RPLS)
English: Sanofi S.p.A Tel: +39 02 39394275
Maltese: Malta Sanofi S.p.ATel: +39 02 39394275
English: • The active substance is vandetanib.
Maltese: Is-sustanza attiva hija vandetanib.
English: Frequencies of occurrence of undesirable effects are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi ta' kemm seħħew l-effetti mhux mixtieqa huma definiti bħala: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥ 1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (< 1/10,000): u mhux magħruf (ma jistax jiġi stmat mid-dejta disponibbli).
English: • Information about the risks of QTc prolongation and Torsades de pointes, and Posterior reversible encephalopathy syndrome (PRES);
Maltese: • Informazzjoni dwar ir-riskji ta' QTc imtawwal u Torsades de pointes, u s-Sindrome enċefalopatika posterjuri riversibbli (PRES);
English: Characteristics of the patients at study entry were the following: mean age 14.2 years (range 9-17 years), 50% female, 50% male, 93.8% White, 26.7% Hispanic and 6.3% were Black.
Maltese: 14.2 ta' sena (tvarja minn 9-17-il sena), 50% nisa, 50% irġiel, 93.8% Bojod, 26.
English: Patients aged 5-18 years should be dosed according to the nomogram in Table 1.
Maltese: Pazjenti bejn 5-18-il sena għandhom jiġu ddożati skont in-nomogramm ta' Tabella 1.
English: In Study 58, RET mutation testing was performed by using the polymerase chain reaction (PCR) based Amplification Refractory Mutation System (ARMS) assay for the M918T mutation, and direct sequencing of DNA for mutations in exons 10, 11, 13, 14, 15 and 16 (site of M918T mutation) on all sporadic patients where DNA was available (297/298).
Maltese: M918T, u sekwenzar dirett tad-DNA għall-mutazzjonijiet fl-exons 10, 11, 13, 14, 15 u 16 (sit tal mutazzjoni M918T) fuq il-pazjenti sporadiċi kollha fejn DNA kien disponibbli (297/298).
English: Pancreatitis, peritonitis, ileus, intestinal perforation, faecal incontinence
Maltese: Pankrejatite, peritonite, ilejus, perforazzjoni flimsaren, inkontinenza talippurgar
English: Prolongation of ECG QTc interval(*) (**)
Maltese: Disturbi fil-qalb Titwil tal-interval QT tal-ECG (*)
English: In the placebo arm, a total of 51 (51%) of patients had progressed: 46 (46%) by RECIST progression and 5 (5%) by death in the absence of progression.
Maltese: Għall-plaċebo, totali ta' 51 (51%) tal-pazjenti kienu avvanzaw; 46 (46%) bl-avvanz RECIST u 5 (5%) b'mewt mingħajr progressjoni.
English: Posology for MTC in adult patients
Maltese: Pożoloġija għal MTC f'pazjenti adulti
English: There were no statistically significant differences observed for the exploratory endpoint of diarrhoea (reported as stool frequency).
Maltese: Ma dehrux differenzi statistikament sinifikanti għal fini esploratorju ta' dijarea (irrappurtata bħala frekwenza tal-ippurgar).
English: • Congenital long QTc syndrome.
Maltese: • Sindrome ta' QTc twila konġenitali
English: Date of latest renewal: 15 January 2019
Maltese: Data tal-ewwel awtorizzazzjoni: 17 Frar 2012 Data tal-aħħar tiġdid: 15 Jannar 2019
English: Heart failure, acute heart failure, rate and rhythm disorders, cardiac conduction disorders, ventricular arrhythmia and cardiac arrest
Maltese: Insuffiċjenza akuta tal-qalb, disturbi fir-rata u r-ritmu, disturbi fil-konduzzjoni kardijaka, arritmija ventrikulari u arrest kardijaku
English: • Involuntary muscle contraction (convulsions).
Maltese: • Kontrazzjonijiet tal-muskoli mhux volontarji (konvulsjonijiet).
English: Table 3: Summary of other efficacy findings in study 58 ORRa
Maltese: Tabella 3: Sommarju ta' sejbiet oħra dwar l-effikaċja fi studju 58 ORRa
English: Vandetanib binds to human serum albumin and alpha-1-acid-glycoprotein with in vitro protein binding being approximately 90%.
Maltese: Distribuzzjoni Vandetanib jintrabat mal-albumina fis-serum tal-bniedem u glikoproteina-aċida-1-alfa bl-irbit mal proteina in vitro jkun madwar 90%.
English: The remaining 158 patients (68%) were censored in the analysis of PFS.
Maltese: Il-158 pazjent li baqa' (68%) kienu ċensurati fl-analiżi tal-PFS.
English: • Loss of appetite (anorexia).
Maltese: • Titlef l-aptit (anoressija).
English: INFORMATION IN BRAILLE Caprelsa 300 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Caprelsa 300 mg
English: • carbamazepine and phenobarbital (used to control seizures)
Maltese: • carbamazepine u phenobarbital (jintużaw sabiex jikkontrollaw l-aċċessjonijiet)
English: Clinical efficacy in adults
Maltese: Effikaċja klinika fl-adulti
English: • Inflammation of the pancreas (pancreatitis).
Maltese: • Infjammazzjoni tal-frixa (pankrejatite).
English: A value > 1 favors vandetanib.
Maltese: Valur > 1 jiffavorixxi vandetanib.
English: • Inflammation of the voice box (larynx).
Maltese: • Infjammazzjoni tal-apparat vokali (larinġi)
English: In healthy subjects with wild type for OCT2, the AUC(0-t) and Cmax for metformin (OCT2 substrate) were increased by 74% and 50%, respectively and CLR of metformin was decreased by 52% when given together with vandetanib.
Maltese: F'individwi b'saħħithom li għandhom tip naturali (wild type) għall-OCT2, l-AUC(0-t) u s-Cmax għal metformin (substrat ta' OCT2) żdiedu b'74% u b'50%, rispettivament u t-tneħħija ta' metformin mill-kliewi tnaqqset bi 52 % meta ngħata flimkien ma' vandetanib.
English: The primary efficacy outcome was ORR according to RECIST v 1.0.
Maltese: Ir-riżultat ewlieni ta' effikaċja kien ORR skont RECIST v 1.0.
English: INFORMATION IN BRAILLE Caprelsa 100 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Caprelsa 100 mg
English: crospovidone (type A), povidone (K29-32), magnesium stearate, hypromellose, macrogol and titanium dioxide (E171).
Maltese: • Is-sustanzi l-oħra huma calcium hydrogen phosphate dihydrate, microcrystalline cellulose, crospovidone (type A), povidone (K29-32), magnesium stearate, hypromellose, macrogol u titanium dioxide (E171).
English: Results should be interpreted with caution due to the high percentage of patients in the placebo arm switching to openlabel vandetanib (79.0% [79/100] of patients).
Maltese: plaċebo li qalbu għal vandetanib open-label (79.0% [79/100] tal-pazjenti).
English: A pharmacokinetic study in volunteers with mild, moderate and severe renal impairment shows that exposure to vandetanib after single dose is increased up to 1.5, 1.6 and 2-fold respectively in patients with mild, moderate (creatinine clearance ≥ 30 to < 50 ml/min) and severe (clearance below 30 ml/min) renal impairment at baseline (see section 5.2).
Maltese: Studju farmakokinetiku f'voluntiera b'indeboliment ħafif, moderat u sever wera esponiment għal vandetanib wara doża waħda jiżdied sa' 1.5-, 1.6-il darba u darbtejn rispettivament f'pazjenti b'indeboliment ħafif, moderat (creatinine clearance >30 sa <50 ml/min) u sever (clearance taħt it-30 ml/min) mil-linja bażi tal-indeboliment renali (ara sezzjoni 5.2).
English: The result of the primary analysis of PFS showed a statistically significant improvement in PFS for patients randomised to vandetanib compared to placebo (Hazard Ratio (HR) = 0.46; 95% Confidence Interval (CI) = 0.31-0.69; p=0.0001).
Maltese: Ir-riżultat tal-analiżi ewlenija tal-PFS wera titjib statistikament sinifikanti fil-PFS għall-pazjenti randomized fuq vandetanib mqabbla mal-plaċebo (Proporzjon tal-Periklu (HR) = 0.46; 95% Intervall tal-Konfidenza (CI) = 0.31-0.69; p=0.0001).
English: Vandetanib at a dose of 300 mg is associated with a substantial and concentration dependent prolongation in QTc (mean 28 msec, median 35 msec).
Maltese: B'doża ta' 300 mg vandetanib huwa assoċjat ma' titwil sostanzjali tal-intervall QTc u dipendenti mal konċentrazzjoni (medja 28 msec, medjan 35 msec).
English: CYP3A4, and vandetanib-N-oxide by flavin-containing monooxygenase enzymes (FM01 and FMO3).
Maltese: N-desmethyl vandetanib jiġi mgħamul l-aktar minn CYP3A4, u vandetanib-N-oxide minn enzimi monooxygenase li jkun fihom il-flavin (FM01 u FMO3).
English: The 300 mg daily dose can be reduced to 200 mg (two 100 mg tablets), and then to 100 mg if necessary.
Maltese: Id-doża ta' 300 mg kuljum tista' titnaqqas għal 200 mg (żewġ pilloli ta' 100 mg), u imbagħad għal 100 mg jekk ikun meħtieġ.
English: * 13.4% vandetanib patients had QTc (Bazett's) ≥ 500 ms compared with 1.0% placebo patients.
Maltese: QTc (ta' Bazett) ≥ 500 ms meta mqabbel ma' 1.0% tal-pazjenti fuq plaċebo.
English: A Phase I/II single-center open-label, single-arm study (Study IRUSZACT0098) assessed the activity of vandetanib in 16 patients with unresectable locally advanced or metastatic hereditary MTC.
Maltese: I/II, b'ċentru wieħed u open-label(L-istudju IRUSZACT0098) evalwa l-attività ta' vandetanib f'16-il pazjent b'MTC ereditarju lokalment avvanzat mhux operabbli jew metastatiku .
English: The pharmacokinetics of vandetanib at the 300 mg dose in MTC patients are characterised by a volume of distribution of approximately 7450 l.
Maltese: Il-farmakokinetika ta' vandetanib b'doża ta' 300 mg f'pazjenti MTC hija karatterizzata b'volum ta' distribuzzjoni ta' madwar 7450 L.
English: Rash and other skin reactions including photosensitivity reactions and palmar-plantar erythrodysaesthesia syndrome have been observed in patients who have received vandetanib.
Maltese: Raxx u reazzjonijiet oħra tal-ġilda inklużi reazzjonijiet ta' fotosensittività u sindrome palmar-plantar eritrodajestiżja dehru f'pazjenti li irċievew vandetanib.
English: • Patients with a QTc interval over 480 msec.
Maltese: • Pazjenti b'intervall QTc itwal minn 480 msec
English: • The summary of Product Characteristics (SmPC);
Maltese: • Is-Sommarju tal-Karatteristiċi tal-Prodott (SmPC);
English: • Disorder of the cornea of the eye (keratopathy).
Maltese: • Disturbi tal-korneja tal-għajn (keratopatija).
English: • PRES should be considered in any patient presenting with seizures, headache, visual disturbances, confusion or altered mental function.
Maltese: • PRES għandu jitqies fi kwalunkwe pazjent b'aċċessjonijiet, uġigħ ta' ras, disturbi tal-vista, konfużjoni jew funzjoni mentali alterata.
English: Of the patients enrolled in the study 10 patients on vandetanib and 4 on placebo (4% of all patients) had a World Health Organization performance status (WHO PS) score of ≥ 2 and 28 (12.1%) patients on vandetanib and 10 (10.1%) on placebo had cardiac impairment.
Maltese: tal-pazjenti kollha) kellhom punteġġ tal-istat ta' prestazzjoni tal-Organizzazzjoni Dinjija tas-Saħħa (WHO PS) ta' ≥ 2 u 28 (12.1%) b'vandetanib u 10 (10.1%) bil-plaċebo kellhom indeboliment kardijaku.
English: Their frequency is presented in Table 2, adverse reactions using Council for International Organizations of Medical Sciences (CIOMS III), listed by MedDRA System Organ Class (SOC) and at the preferred term level and then by frequency classification.
Maltese: reazzjonijiet avversi permezz tal-Kunsill għall-Organizzazzjonijiet Internazzjonali tax-Xjenzi Mediċini (CIOMS III) elenkati permezz tas-Sistema tal-Klassi tal-Organi (SOC) MedDRA u fil-livell tattermini preferit u wara permezz tal-klassifika tal-frekwenza.
English: Vandetanib is not recommended for use in adult and paediatric patients with hepatic impairment (serum bilirubin greater than 1.5 times upper limit of reference range (ULRR), this criterion does not apply to patients with Gilbert's Disease and alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) greater than 2.5 times ULRR, or greater than 5.0 times ULRR if judged by the physician to be related to liver metastases), since there is limited data in patients with hepatic impairment, and safety and efficacy have not been established (see section 4.4).
Maltese: (bilirubin fis-serum aktar minn 1.5 l-ogħla limitu tal-marġni ta' riferenza (ULRR), dan il-kriterju ma japplikax għal pazjenti b'Gilbert's Disease- u alanine aminotransferase (ALT), aspartate aminotransferase (AST),jew alkaline phosphatase (ALP) aktar minn 2.5 darbiet l-ULRR, jew akbar minn 5.0 darbiet l-ULRR jekk l-ispeċjalista huwa tal-fehma li dan għandu x'jaqsam ma' metastasi fil-fwied), tan-normali), peress li hemm dejta limitata f'pazjenti b'indeboliment tal-fwied, u s-sigurtà u l-effikaċja ma ġewx stabbiliti (ara sezzjoni 4.4).
English: There is limited data in patients with hepatic impairment (serum bilirubin greater than 1.5 times upper limit of normal (see sections 4.2 and 4.4).
Maltese: (bilirubin fis-serum akbar minn 1.5-il darba l-ogħla limitu tan-normali (ara sezzjoni 4.2 u 4.4).
English: CTN less than 500 pg/ml
Maltese: CTN anqas minn 500 pg/ml
English: Twenty-eight of the 231 patients (12.1%) on vandetanib and 3 of the 99 (3.0%) on placebo discontinued treatment because of an adverse event.
Maltese: Tmienja u għoxrin minn 231 pazjent (12.1%) fuq vandetanib u 3 mid-99 (3.0%) fuq plaċebo ma komplewx il-kura minħabba xi episodju avvers.
English: In ex vivo plasma samples from colorectal cancer patients at steady state exposure after 300 mg once daily, the mean percentage protein binding was 93.7% (range 92.2 to 95.7%).
Maltese: F'kampjuni ta' plażma ex vivo minn pazjenti b'kanċer tal kolon/rektum b'esponiment fi stat fiss wara 300 mg darba kuljum, il-medja tal-perċentwali tal-irbit mal-proteina kien 93.7% (medda minn 92.2 sa 95.7 %).
English: Other medicines and Caprelsa
Maltese: Mediċini oħra u Caprelsa
English: Table 1: Dosing nomogram for Paediatric Patients with MTC BSA (m2)
Maltese: Tabella 1:Nomogramm ta' dożaġġ għal Pazjenti Pedjatriċi b'MTC
English: • Blistering of skin (bullous dermatitis).
Maltese: • Bżieżaq fil-ġilda (dermatite bl-imsiemer).
English: The concomitant use of vandetanib with strong CYP3A4 inducers (such as rifampicin, St John's Wort, carbamazepine, phenobarbital) should be avoided (see section 4.5).
Maltese: (bħal rifampicin, St John's Wort, carbamazepine, phenobarbital) għandhom jiġu evitati (ara sezzjoni 4.5).
English: Vandetanib doses higher than 150 mg/m2 have not been used in clinical studies in paediatric patients.
Maltese: Vandetanib ogħla minn 150 mg/m2 ma ntużawx f'studji kliniċi f'pazjenti pedjatriċi.
English: • Severe diarrhoea.
Maltese: • Dijarea severa.
English: Vandetanib has shown no mutagenic or clastogenic potential.
Maltese: Vandetanib ma wera l-ebda potenzjal mutaġeniku jew klastoġeniku.
English: Visual impairment, halo vision, photopsia, glaucoma, conjunctivitis, dry eye, keratopathy
Maltese: Indeboliment tal-vista, Halo vision, fotopsja, glawkoma,
English: • Combinations contraindicated (see section 4.3): Cisapride, erythromycin intravenous (IV), toremifene, mizolastine, moxifloxacin, arsenic, Class IA and III antiarrhythmics
Maltese: Arsenic cisapride, erythromycin intravenous (IV), toremifene, mizolastine, moxifloxacin, anti-arritmijaċi tal-klassi IA u III (ara sezzjoni 4.5).
English: Cardiac impairment was defined as patients with previous cardiovascular abnormality.
Maltese: Indeboliment kardjiaku kien definit bħala dawk il-pazjenti li kellhom anormalità kardijaka minn qabel.
English: The pharmacokinetic parameters of vandetanib in paediatrics MTC patients aged 9-17 years were similar to those in adults.
Maltese: Il-parametri farmakokinetiċi ta' vandetanib f'pazjenti pedjatriċi b'MTC b'etajiet minn 9-17-il sena kienu simili għal dawk fl-adulti.
English: In healthy subjects, no clinically significant interaction was shown between vandetanib (a single dose of 300mg) and the potent CYP3A4 inhibitor, itraconazole (repeated doses of 200mg once daily).
Maltese: L-effett ta' prodotti mediċinali oħra fuq vandetanib F'individwi b'saħħithom, ma dehret l-ebda interazzjoni klinikament sinifikanti bejn vandetanib (doża waħda ta' 300mg) u l-inibitur qawwi ta' CYP3A4, itraconazole (dożi ripetuti ta' 200mg darba kuljum).
English: ECG QTc interval prolonged
Maltese: Investigazzjonijiet Titwil tal-interval QTc tal-ECG
English: In the vandetanib arm, a total of 73 (32%) patients progressed: 64 (28%) by response evaluation criteria in solid tumours (RECIST) progression and 9 (4%) by death in the absence of progression.
Maltese: Għal vandetanib, totali ta' 73 (32%) tal-pazjenti kienu avvanzaw; 64 (28%) bil-kriterji tal-evalwazzjoni skont ir-rispons f'tumuri solidi (RECIST) u 9 (4%) b'mewt mingħajr avvanz tal-marda.
English: Additional monitoring of QTc, electrolytes and renal function are required especially in case of diarrhoea, increase in diarrhoea/dehydration, electrolyte imbalance and/or impaired renal function.
Maltese: Aktar monitoraġġ tal-QTc, elettroliti u funzjoni renali huwa meħtieġ l-aktar f'każ ta' dijarea, żieda fid dijarea/deidratazzjoni, żbilanċ fl-elettroliti u/jew funzjoni renali indebolita.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal xi sustanzi mhux attivi elenkati fis sezzjoni 6.1.
English: QTc interval should be carefully assessed prior to initiation of treatment.
Maltese: L-intervall QTc għandu jiġi evalwat bir-reqqa qabel ma tinbeda t-terapija.
English: months n-vandetanib 231 196 169 140 40 1 0 n-placebo 100 71 57 45 13 0 0 ____ vandetanib 300 mg, ------ placebo, y-axis=PFS, x-axis=time in months, n-vandetanib=number of patients at risk-vandetanib, n-placebo=number of patients at risk-placebo HR = 0.46, 95%CI (0.31-0.69), p = 0.0001
Maltese: ____ vandetanib 300 mg, ------ plaċebo, y-axis=PFS, x-axis=ħin f'xhur, n-vandetanib=numru ta' pazjenti li għandhom riskju -vandetanib, n-plaċebo= numru ta' pazjenti li għandhom riskju -placebo
English: Hypothyroidism
Maltese: ipokalċimja
English: Vandetanib is also a sub-micromolar inhibitor of vascular endothelial receptor-3 tyrosine kinase.
Maltese: Vandetanib huwa wkoll inibitur sub-mikromolari tal-kajnejż tat-tajrosin tar-riċettur 3 tal-endotilju.
English: Headache, paraesthesia, dysaesthesia, dizziness
Maltese: stomatite, disfaġja,
English: • Nose bleed (epistaxis).
Maltese: • Tinfaraġ (epistassi).
English: Chromaturia, anuria
Maltese: Kromaturja, anurja
English: • Dizziness.
Maltese: • De-idratazzjoni.
English: Within a 21 day collection period after a single dose of 14C-vandetanib, approximately 69% was recovered with 44% in faeces and 25% in urine.
Maltese: F'perijodu ta' 21 jum ta' kollezzjoni wara doża waħda ta' 14C-vandetanib, madwar 69% kienu irkuprati b'44% fil-purgar u 25% fl-awrina.
English: Vandetanib inhibits VEGF-stimulated endothelial cell migration, proliferation, survival and new blood vessel formation in in vitro models of angiogenesis.
Maltese: Vandetanib jinibixxi l-migrazzjoni stimulata mill-VEGF fl-endotilju, il-proliferazzjoni u s sopravivenza u l-formazzjoni ta' vini ġodda f'mudelli in vitro tal-anġjoġenesi.
English: Following oral dosing of 14C- vandetanib, unchanged vandetanib and metabolites vandetanib N-oxide and N-desmethyl vandetanib were detected in plasma, urine and feces.
Maltese: Bijotrasformazzjoni Wara dożaġġi orali ta' 14C-vandetanib, vandetanib mhux mibdul u l-metaboli vandetanib N-oxide u
English: The remaining 49 patients (49%) were censored in the analysis of PFS.
Maltese: Id-49 pazjent li baqa' (49%) kienu ċensurati fl-analiżi tal-PFS.
English: In healthy male subjects, the exposure to vandetanib was reduced by 40% when given together with the potent CYP3A4 inducer, rifampicin.
Maltese: F'irġiel b'saħħithom, l-espożizzjoni għal vandetanib tnaqqset b'40% meta ngħata flimkien mal-induttur CYP3A4 qawwi, rifampicin.
English: Fertility In rats, vandetanib had no effect on male fertility but impaired female fertility (see section 5.3).
Maltese: Fil-firien, vandetanib ma kellux effett fuq il-fertilità maskili iżda l-fertilità femminili kienet indebolita (ara sezzjoni 5.3).
English: • Inflammation of the lung tissue.
Maltese: • Infjammazzjoni tat-tessuti tal-pulmun.
English: There is limited data with 300 mg in patients with moderate renal impairment: the dose needed to be lowered to 200 mg in 5 out of 6 patients.
Maltese: Hemm dejta limitata b'300 mg f'pazjenti b'indeboliment renali moderat: id-doża meħtieġa sabiex titniżżel għal 200 mg f'5 minn 6 pazjenti.
English: CTN Response
Maltese: Rispons CTN
English: Breast-feeding
Maltese: Fil-fatt
English: Epistaxis, haemoptysis, pneumonitis
Maltese: Epistassi, emoptisi, pnewmonite
English: In healthy subjects, the AUC(0-t) and Cmax for digoxin (P-gp substrate) were increased by 23% and 29% respectively, when given together due to P-gp inhibition by vandetanib.
Maltese: F'individwi b'saħħithom, l-AUC(0-t) u s-Cmax ta' digoxin (substrat tal-glikoproteina-P (P-gp)) żdiedu bi 23 % u b'29 % rispettivament, meta ngħataw flimkien minħabba l-inibizzjoni tal-P-gp b'vandetanib.
English: Vandetanib also showed evidence of phototoxic potential in an in vitro cytotoxicity assay.
Maltese: Vandetanib wera wkoll potenzjal fototossiku f'essej ċitotossiku in vitro.
English: EXP
Maltese: ORb
English: At various exposure durations, median haemoglobin levels in patients treated with vandetanib were increased by 0.5-1.5 g/dl compared to baseline.
Maltese: Waqt esponimenti ta' tul differenti, il-livelli ta' emoglobina medjana f'pazjenti ikkurati b'vandetanib kienu misżjuda b' 0.5-15 g/dl meta mqabbla mal-linja bażi.
English: Paediatric clinical trial data with vandetanib in MTC (see section 5.1) obtained during drug development is limited to 16 patients aged 9 years to 17 years with hereditary medullary thyroid carcinoma (Study IRUSZACT0098).
Maltese: Popolazzjoni pedjatrika Tagħrif minn prova klinika pedjatrika b'vandetanib f'MTC (ara sezzjoni 5.1) miksub waqt l-iżvilupp tal-mediċina huwa limitat għal 16-il pazjent b'etajiet minn 9 snin sa 17-il sena b'karċinoma ereditarja medullari tat-tirojde (L-istudju IRUSZACT0098).
English: Caprelsa is indicated in adults, children and adolescents aged 5 years and older.
Maltese: Caprelsa hija indikata fl-adulti, fit-tfal u fl-adolexxenti mill-età ta' 5 snin 'il fuq.
English: • Sore mouth (stomatitis).
Maltese: • Ħalq misluħ (stomatite).
English: Events such as Torsades de pointes, Stevens-Johnson syndrome, erythema multiforme, interstitial lung disease (sometimes fatal) and PRES (RPLS) have occurred in patients treated with vandetanib monotherapy.
Maltese: Deskrizzjoni ta' reazzjonijiet avversi partikulari Episodji bħal Torsades de pointes, Sindrome ta' Stevens-Johnson, eritema multiforme, mard fl interstizju tal-pulmun (xi kultant fatali) u PRES(RPLS)seħħew f'pazjenti ikkurati b'monoterapija b'vandetanib.