FrancophonIA/ELRC3.0 huggingface dataset:
English: Figure 1: Kaplan Meier curve for progression-free survival by independent radiology review committee, in RCC subjects following prior vascular endothelial growth factor (VEGF)targeted therapy (first 375 subjects randomized) (METEOR)
Maltese: Figura 1: Kurva Kaplan Meier għas-sopravivenza mingħajr progressjoni minn kumitat ta' analiżi radjoloġika indipendenti, f'individwi b'RCC wara terapija preċedenti mmirata lejn il-fattur tattkabbir tal-endotelju vaskulari (VEGF) (l-ewwel 375 individwu randomised) (METEOR)
English: In the study in RCC following prior VEGF-targeted therapy (METEOR), fistulas were reported in 1.2% (4/331) of cabozantinib-treated patients and included anal fistulas in 0.6% (2/331) cabozantinibtreated patients.
Maltese: Fl-istudju dwar RCC wara terapija preċedenti mmirata lejn VEGF (METEOR), fistuli kienu rrappurtati f'1.2% (4/331) tal-pazjenti ttrattati b'cabozantinib u kienu jinkludu fistuli anali f'0.6% (2/331) tal-pazjenti ttrattati b'cabozantinib.
English: Metabolism and nutrition disorders decreased appetite, hypomagnesaemia, hypokalaemia dehydration, hypoalbuminaemia, hypophosphataemia, hyponatraemia, hypocalcaemia, hyperkalaemia, hyperbilirubinemia hyperglycaemia, hypoglycaemia
Maltese: Disturbi filmetaboliżmu u nnutrizzjoni tnaqqis fl-aptit, ipomagnesimja, ipokalimja deidratazzjoni, ipoalbuminimja, ipofosfatimja, iponatrimija, ipokalċimija, iperkalimja, iperbilirubinimja, ipergliċemija, ipogliċemija
English: For intermediate risk disease, one or two of the following risk factors were met, while for poor risk, three or more factors were met: time from diagnosis of RCC to systemic treatment < 1 year, Hgb < LLN, Corrected calcium > ULN, KPS < 80%, Neutrophil count > ULN and Platelet count > ULN.
Maltese: Għal mard b'riskju intermedju, kien hemm wieħed jew tnejn mill-fatturi ta' riskju li ġejjien, filwaqt li fil-każ ta' riskju baxx, kien hemm tliet fatturi jew aktar: żmien mid-dijanjosi ta' RCC sa trattament sistemiku < sena, Hgb < LLN, Kalċju kkorreġut > ULN, KPS < 80%, Għadd ta' newtrofili > ULN u Għadd ta' plejtlits > ULN.
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:
Maltese: Reazzjonijiet avversi li ma kinux osservati fi studji kliniċi, iżda dehru fl-annimali f'livelli ta' esponiment simili għal-livelli ta' esponiment kliniku u b'rilevanza possibbli għall-użu kliniku kienu kif ġej:
English: Infections and infestations abscess
Maltese: Infezzjonijiet u infestazzjonijiet axxess
English: Clinical data in renal cell carcinoma following prior vascular endothelial growth factor (VEGF)targeted therapy
Maltese: Data klinika f'karċinoma taċ-ċellula renali wara terapija preċedenti mmirata lejn il-fattur tat-tkabbir talendotelju vaskulari (VEGF - vascular endothelial growth factor)
English: In a population PK analysis of cabozantinib using data collected from 1883 patients and 140 healthy volunteers following oral administration of a range of doses from 20 to 140 mg, the plasma terminal half-life of cabozantinib is approximately 110 hours.
Maltese: F'analiżi PK tal-popolazzjoni ta' cabozantinib bl-użu ta' data miġbura minn 1883 pazjent u 140 voluntier normali f'saħħithom wara għoti mill-ħalq ta' firxa ta' dożi minn 20 sa 140 mg, il-half-life terminal ta' cabozantinib fil-plażma hija madwar 110 sigħat.
English: Hazard ratio < 1 indicates progression-free survival in favor of cabozantinib
Maltese: Proporzjon ta' periklu < 1 jindika sopravivenza mingħajr progressjoni favur cabozantinib
English: PVC/PCTFE blister with push-through aluminum foil backing containing 7 film-coated tablets.
Maltese: Folja tal-PVC/PCTFE b'kisja push-through tal-fojl tal-aluminju li fiha 7 pilloli miksija b'rita.
English: The safety and efficacy of cabozantinib in children and adolescents aged <18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' cabozantinib fit-tfal u fl-adolexxenti ta' età <18-il sena għadhom ma ġewx determinati s'issa.
English: - Medicines that treat fungal infections, such as itraconazole, ketoconazole, and posaconazole - Medicines used to treat bacterial infections (antibiotics) such as erythromycin, clarithromycin,
Maltese: - Mediċini li jittrattaw infezzjonijiet ikkawżati mill-moffa, bħal itraconazole, ketoconazole, u posaconazole - Mediċini użati biex jittrattaw infezzjonijiet ikkawżati mill-batterja (antibijotiċi) bħal erythromycin,
English: No case of RPLS was reported in the METEOR or CABOSUN or CELESTIAL studies, but RPLS has been reported rarely in other clinical studies (in 2/4872 subjects; 0.04%).
Maltese: Fl-istudji METEOR jew CABOSUN jew CELESTIAL ma kien irrappurtat l-ebda każ ta' RPLS, iżda RPLS ġiet irrappurtata b'mod rari fi studji kliniċi oħra (fi 2/4872 individwu; 0.04%).
English: Juvenile rats (comparable to a >2 year- old paediatric population) administered cabozantinib showed increased WBC parameters, decreased haematopoiesis, pubescent/immature female reproductive system (without delayed vaginal opening), tooth abnormalities, reduced bone mineral content and density, liver pigmentation and lymph node lymphoid hyperplasia.
Maltese: Firien frieħ (komparabbli ma' popolazzjoni pedjatrika ta' >sentejn) li ngħataw cabozantinib urew żieda filparametri ta' WBC, tnaqqis fl-ematopoesi, sistema riproduttiva tal-mara pubixxenti/immatura (mingħajr dewmien fil-ftuħ tal-vaġina), anormalitajiet fis-snien, kontenut u densità imnaqqsa ta' minerali fl-għadam, pigmentazzjoni fil-fwied u iperplasja limfojda tal-glandoli limfatiċi.
English: CABOMETYX (cabozantinib) tablets and COMETRIQ (cabozantinib) capsules are not bioequivalent and should not be used interchangeably (see section 5.2).
Maltese: Il-pilloli CABOMETYX (cabozantinib) u l-kapsuli COMETRIQ (cabozantinib) mhumiex bijoekwivalenti u m'għandhomx jiġu wżati minflok xulxin (ara sezzjoni 5.2).
English: Tumour assessments were conducted every 8 weeks.
Maltese: Valutazzjonijiet tat-tumuri twettqu kull 8 ġimgħat.
English: In the study in RCC following prior VEGF-targeted therapy (METEOR), GI perforations were reported in 0.9% (3/331) of cabozantinib-treated RCC patients.
Maltese: Fl-istudju dwar RCC wara terapija preċedenti mmirata lejn VEGF (METEOR), perforazzjonijiet GI kienu rrappurtati f'0.9% (3/331) tal-pazjenti b'RCC ittrattati b'cabozantinib.
English: CABOMETYX 20 mg film-coated tablets CABOMETYX 40 mg film-coated tablets CABOMETYX 60 mg film-coated tablets cabozantinib
Maltese: CABOMETYX 20 mg pilloli miksija b'rita CABOMETYX 40 mg pilloli miksija b'rita CABOMETYX 60 mg pilloli miksija b'rita cabozantinib
English: • Haemorrhoids (piles)
Maltese: • Pressjoni għolja (żieda fil-pressjoni)
English: Progressive Disease a in accord with EU censoring b Stratification factors per IxRS comprise IMDC risk categories (intermediate risk, poor risk and bone metastasis (yes, no) c Estimated using the Cox proportional hazard model adjusted for stratification factors per IxRS.
Maltese: Marda Progressiva a skont iċ-ċensura tal-UE b Il-fatturi ta' stratifikazzjoni kull IxRS jinkludu l-kategoriji ta' riskju tal-IMDC (riskju intermedju, riskju baxx u metastasi fl-għadam (iva, le) c Stmat bl-użu tal-mudell tal-periklu proporzjonali Cox aġġustat għall-fatturi ta' stratifikazzjoni kull IxRS.
English: Administration of the strong CYP3A4 inducer rifampicin (600 mg daily for 31 days) to healthy volunteers increased cabozantinib clearance (4.3-fold) and decreased single-dose plasma cabozantinib exposure (AUC) by 77%.
Maltese: L-għoti tal-induttur qawwi ta' CYP3A4 rifampicin (600 mg kuljum għal 31 jum) lil voluntiera f'saħħithom żied it-tneħħija ta' cabozantinib (b'4.3 darbiet) u naqqas l-esponiment għal doża waħda ta' cabozantinib filplażma (AUC) b'77%.
English: • Gastro-oesophageal reflux disease (bringing up stomach acid)
Maltese: • Marda ta' rifluss gastro-intestinali (ittella' aċidu mill-istonku)
English: Injury, poisoning and procedural complications wound complications
Maltese: Korriment, avvelenament u komplikazzjonijiet ta' xi proċedura komplikazzjonijiet fil-feriti
English: ORR (partial responses only) Stable disease
Maltese: ORR (rispons parzjali biss) Marda stabbli
English: Cabozantinib was an inhibitor (IC50 = 7.0 μM), but not a substrate, of P-gp transport activities in a bi-directional assay system using MDCK-MDR1 cells.
Maltese: Cabozantinib kien inibitur (IC50 = 7.0 μM), iżda mhux sottostrat, ta' attivitajiet ta' ġarr ta' P-gp f'sistema ta' assaġġ b'żewġ direzzjonijiet bl-użu ta' ċelluli MDCK-MDR1.
English: Clinical data in treatment-naïve renal cell carcinoma
Maltese: Data klinika f'karċinoma taċ-ċellula renali li qatt ma ġiet ittrattata qabel
English: Concomitant medicinal products that are strong inhibitors of CYP3A4 should be used with caution, and chronic use of concomitant medicinal products that are strong inducers of CYP3A4 should be avoided (see sections 4.4 and 4.5).
Maltese: Prodotti mediċinali li jittieħdu fl-istess waqt li huma inibituri qawwija ta' CYP3A4 għandhom jintużaw b'kawtela, u użu kroniku ta' prodotti mediċinali li jittieħdu fl-istess waqt li huma indutturi qawwija ta' CYP3A4 għandu jiġi evitat (ara sezzjonjiet 4.4 u 4.5).
English: The effects of CABOMETYX in people younger than 18 years old are not known.
Maltese: L-effetti ta' CABOMETYX f'persuni iżgħar minn 18-il sena mhumiex magħrufa.
English: In the study in RCC following prior VEGF-targeted therapy (METEOR), the incidence of severe haemorrhagic events (Grade ≥ 3) was 2.1% (7/331) in cabozantinib-treated RCC patients.
Maltese: Fl-istudju dwar RCC wara terapija preċedenti mmirata lejn VEGF (METEOR), l-inċidenza ta' avvenimenti ta' emorraġija severa (Grad ≥ 3) kienet ta' 2.1% (7/331) fil-pazjenti b'RCC ittrattati b'cabozantinib.
English: Cabozantinib has been associated with an increased incidence of electrolyte abnormalities (including hypo- and hyperkalaemia, hypomagnesaemia, hypocalcaemia, hyponatremia).
Maltese: Cabozantinib ġie assoċjat ma' żieda fl-inċidenza ta' anormalitajiet fl-elettroliti (li jinkludu ipokalimja u iperkalimja, ipomanjesimja, ipokalċimija, iponatrimija).
English: The median duration of treatment was 7.6 months (range 0.3 - 20.5) for patients receiving CABOMETYX and 4.4 months (range 0.21 - 18.9) for patients receiving everolimus.
Maltese: It-tul medjan tat-trattament kien ta' 7.6 xhur (firxa 0.3 - 20.5) għall-pazjenti li rċevew CABOMETYX u 4.4 xhur (firxa 0.21 - 18.9) għall-pazjenti li rċevew everolimus.
English: For RCC and HCC, the recommended dose of CABOMETYX is 60 mg once daily.
Maltese: Għal RCC u HCC, id-doża rakkomandata ta' CABOMETYX hija 60 mg darba kuljum.
English: Cabozantinib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs) implicated in tumour growth and angiogenesis, pathologic bone remodeling, drug resistance, and metastatic progression of cancer.
Maltese: Cabozantinib huwa molekula żgħira li tnibixxi riċetturi tyrosine kinases (RTKs - receptor tyrosine kinases) multipli implikati fit-tkabbir tat-tumur u anġjoġenesi, immudellar mill-ġdid patoloġiku tal-għadam, reżistenza għall-mediċini, u progressjoni metastatika tal-kanċer.
English: In renal cell carcinoma following prior vascular endothelial growth factor (VEGF)-targeted therapy, dose reductions and dose interruptions due to an AE occurred in 59.8% and 70%, respectively, of cabozantinib-treated patients in the pivotal clinical trial (METEOR).
Maltese: F'karċinoma taċ-ċellula renali wara terapija preċedenti mmirata lejn il-fattur tat-tkabbir tal-endotelju vaskolari (VEGF - vascular endothelial growth factor), tnaqqis fid-doża jew interruzzjonijiet fid-doża minħabba AE seħħew f'59.8% u 70%, rispettivament, tal-pazjenti ttrattati b'cabozantinib fil-prova klinika pivitali (METEOR).
English: Wound complications have been observed with cabozantinib.
Maltese: Komplikazzjonijiet fil-ferita ġew osservati b'cabozantinib.
English: In the treatment-naïve RCC study (CABOSUN), the incidence of severe haemorrhagic events (Grade ≥ 3) was 5.1% (4/78) in cabozantinib-treated RCC patients.
Maltese: Fl-istudju dwar RCC li ma ġietx ittrattata qabel (CABOSUN), l-inċidenza ta' avvenimenti emorraġiċi severi (Grad ≥ 3) kienet ta' 5.1% (4/78) f'pazjenti b'RCC ittrattata b'cabozantinib.
English: How to store CABOMETYX 6.
Maltese: Kif taħżen CABOMETYX 6.
English: Co-administration of proton pump inhibitor (PPI) esomeprazole (40 mg daily for 6 days) with a single dose of 100 mg cabozantinib to healthy volunteers resulted in no clinically-significant effect on plasma cabozantinib exposure (AUC).
Maltese: L-għoti tal-inibitur tal-pompa tal-protoni (PPI - proton pump inhibitor) esomeprazole (40 mg kuljum għal 6 ijiem) flimkien ma' doża waħda ta' 100 mg cabozantinib lil voluntiera f'saħħithom ma wassalx għal effett klinikament sinifikanti fuq l-esponiment għal cabozantinib fil-plażma (AUC).
English: Presence of macroscopic vascular invasion and/ or extra-hepatic tumour spread:78%, Alfa-fetoprotein (AFP) levels ≥400 μg/L: 41%.
Maltese: Preżenza ta' invażjoni vaskulari makroskopika u/jew firxa ekstraepatika tat-tumur: 78% Proċeduri ta' embolizzazzjoni transarterjali lokoreġjonali jew ta' kimoinfużjoni: 44% Radjuterapija qabel trattament b'cabozantinib:
English: Severe haemorrhage, sometimes fatal, has been observed with cabozantinib.
Maltese: Emorraġija severa, xi drabi fatali, ġiet osservata b'cabozantinib.
English: CABOMETYX 20 mg film-coated tablets CABOMETYX 40 mg film-coated tablets CABOMETYX 60 mg film-coated tablets
Maltese: CABOMETYX 20 mg pilloli miksija b'rita CABOMETYX 40 mg pilloli miksija b'rita CABOMETYX 60 mg pilloli miksija b'rita
English: The European Medicines Agency has waived the obligation to submit the results of studies with CABOMETYX in all subsets of the paediatric population in treatment of hepatocellular carcinoma, and 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 irrinunzjat għall-obbligu li jigu ppreżentati r-riżultati tal-istudji b'CABOMETYX f'kull sett tal-popolazzjoni pedjatrika fit-trattament ta' karċinoma epatoċellulari, u karċinoma tal-kliewi u tal-pelvi renali (minbarra nefroblastoma, nefroblastomatosi, sarkoma taċ-ċelluli ċari, nefroma mesoblastika, karċinoma tal-medulla tal-kliewi u tumur rhabdoid tal-kliewi) (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: CABOMETYX treatment was associated with a trend for longer survival compared to sunitinib (Table 5).
Maltese: It-trattament b'CABOMETYX kien assoċjat ma' tendenza għal sopravivenza itwal imqabbel ma' sunitinib (Tabella 5).
English: The most common serious adverse drug reactions in the HCC population (≥1% incidence) are hepatic encephalopathy, palmar-plantar erythrodysaesthesia syndrome, asthenia and diarrhoea.
Maltese: L-aktar reazzjonijiet avversi tal-mediċina serji komuni fil-popolazzjoni b'HCC (inċidenza ta' ≥1%) huma enċefalopatija tal-fwied, is-sindrome ta' eritrodisasteżija palmari-plantari, astenja u dijarea.
English: General disorders and administration site conditions fatigue, mucosal inflammation, asthenia, peripheral oedema
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata għeja, infjammazzjoni talmukuża, astenja, edima periferali
English: CABOMETYX Placebo these therapies had to discontinue study treatment.
Maltese: CABOMETYX Plaċebo trattament tal-istudju.
English: Blood and lymphatic disorders anaemia thrombocytopenia, neutropenia lymphopenia
Maltese: Disturbi tad-demm u tas-sistema limfatika anemija tromboċitopenija, newtropenija limfopenija
English: Within a 48-day collection period after a single dose of 14C-cabozantinib in healthy volunteers, approximately 81% of the total administered radioactivity was recovered with 54% in faeces and 27% in urine.
Maltese: F'perjodu ta' ġbir ta' 48 ġurnata wara doża singola ta' 14C-cabozantinib f'voluntiera f'saħħithom, madwar 81% tar-radjuattività totali mogħtija kienet irkuprata b'54% fl-ippurgar u 27% flawrina.
English: RPLS is rare (it affects less than 1 in 1000 people).
Maltese: RPLS isseħħ b'mod rari (taffettwa inqas minn persuna waħda minn kull 1000).
English: In the HCC study (CELESTIAL), fatal haemorrhagic events were reported at a higher incidence with cabozantinib than placebo.
Maltese: Fl-istudju dwar HCC (CELESTIAL), avvenimenti emorraġiċi fatali kienu rrappurtati b'inċidenza ogħla b'cabozantinib milli bil-plaċebo.
English: Fatal perforations have occurred in the cabozantinib clinical program.
Maltese: Perforazzjonijiet fatali seħħew fil-programm kliniku dwar cabozantinib.
English: The tablets are yellow round with no score, and debossed with “XL” on one side and “20” on the other side of the tablet.
Maltese: Il-pilloli huma sofor, tondi mingħajr sinjal imnaqqax, u mnaqqxa b'“XL” fuq naħa waħda u “20” fuq in-naħa l-oħra tal-pillola.
English: • Stomach upset, including diarrhoea, nausea, vomiting, constipation, indigestion, abdominal pain,
Maltese: • Stonku mdardar, inkluż dijarea, dardir, rimettar, stitikezza, indiġestjoni, uġigħ addominali,
English: CABOMETYX is indicated for the treatment of advanced renal cell carcinoma (RCC): - in treatment-naïve adults with intermediate or poor risk (see section 5.1) - in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy
Maltese: - f'adulti li qatt ma ħadu trattament qabel b'riskju intermedju jew baxx (ara sezzjoni 5.1) - f'adulti wara terapija preċedenti mmirata lejn il-fattur tat-tkabbir tal-endotelju vaskulari (VEGF
English: A statistically significant improvement in OS was demonstrated for CABOMETYX compared to placebo (Table 6 and Figure 4).
Maltese: Titjib statistikament sinifikanti f'OS intwera għal CABOMETYX meta mqabbel mal-plaċebo (it-Tabella 6 u l-Figura 4).
English: Figure 2: Kaplan-Meier curve of overall survival in RCC subjects following prior vascular endothelial growth factor (VEGF)-targeted therapy (METEOR)
Maltese: Kaplan-Meier tas-sopravivenza globali f'individwi b'RCC wara terapija preċedenti mmirata lejn il-fattur tat-tkabbir tal-endotelju vaskulari (VEGF - vascular endothelial growth factor) (METEOR)
English: Fatal haemorrhages have occurred in the cabozantinib clinical program.
Maltese: Emorraġiji fatali seħħew fil-programm kliniku dwar cabozantinib.
English: Comparable results for OS were observed with a follow-up analysis (descriptive) at 430 events.
Maltese: Riżultati komparabbli għal OS kienu osservati b'analiżi (deskrittiva) ta' segwitu f'430 avveniment.
English: Posology
Maltese: Képviselet
English: • Dry skin, severe itching of skin, acne
Maltese: • Ġilda xotta, ħakk kbir tal-ġilda, akne
English: A negative effect of Cabometyx versus placebo on the EQ-5D utility index score was observed during the first weeks of treatment.
Maltese: Effett negattiv ta' Cabometyx kontra l-plaċebo fuq il-punteġġ tal-indiċi ta' utilità EQ-5D ġie osservat matul l-ewwel ġimgħat ta' trattament.
English: Seventy-one percent (71%) received only one prior VEGFR TKI; 41% of patients received sunitinib as their only prior VEGFR TKI.
Maltese: Wieħed u sebgħin (71%) fil-mija irċevew VEGFR TKI wieħed biss minn qabel; 41% tal-pazjenti rċevew sunitinib bħala luniku VEGFR TKI tagħhom minn qabel.
English: No dose adjustment is necessary based on ethnicity (see section 5.2)
Maltese: Mhux meħtieġ aġġustament fid-doża bbażat fuq l-etniċità (ara sezzjoni 5.2).
English: One event was Grade 3; the remainder were Grade 2.
Maltese: Avveniment wieħed kien ta' Grad 3; il-kumplament kienu ta' Grad 2.
English: Hypertension has been observed with cabozantinib.
Maltese: Pressjoni għolja ġiet osservata b'cabozantinib.
English: The most frequent adverse reactions of any grade (experienced by at least 25% of patients) in the RCC population included diarrhoea, hypertension, fatigue, AST increased, ALT increased, nausea, decreased appetite, PPES, dysgeusia, platelet count decreased, stomatitis, anaemia, vomiting, weight decreased, dyspepsia, and constipation.
Maltese: Ir-reazzjonijiet avversi l-aktar frekwenti ta' kwalunkwe grad (li esperjenzaw mill-inqas 25% tal-pazjenti) filpopolazzjoni b'RCC kienu jinkludu dijarea, pressjoni għolja, għeja kbira, żieda fl-AST, żieda fl-ALT, dardir, tnaqqis fl-aptit, PPES, bidla fit-togħma, tnaqqis fl-għadd ta' plejtlits, stomatite, anemija, rimettar, tnaqqis filpiż, dispepsja, u stitikezza.
English: Hepatic encephalopathy hepatitis cholestatic
Maltese: Enċefalopatija talfwied epatite kolestatika
English: In the HCC study (CELESTIAL), thrombocytopenia and decreased platelets were reported.
Maltese: Fl-istudju dwar HCC (CELESTIAL), ġew irrappurtati tromboċitopenija u tnaqqis fil-plejtlits.
English: The clinical significance of these potential interactions is unknown.
Maltese: Is-sinifikat kliniku ta' dawn l-interazzjonijiet potenzjali mhux magħruf.
English: Nervous system disorders dysgeusia, headache, dizziness peripheral sensory neuropathy convulsion cerebrovascul ar accident
Maltese: Disturbi fis-sistema nervuża disgewżja, uġigħ ta' ras, sturdament newropatija tassensazzjoni periferali konvulżjoni inċident ċerebrovaskulari
English: In rat and dog repeat-dose toxicity studies up to 6 months duration, target organs for toxicity were GI tract, bone marrow, lymphoid tissues, kidney, adrenal and reproductive tract tissues.
Maltese: Fi studji dwar l-effett tossiku minn dożi ripetuti fil-firien u l-klieb li damu sa 6 xhur, organi mmirati għattossiċità kienu l-passaġġ GI, il-mudullun, tessuti limfojdi, il-kliewi, tessuti adrenali u tal-passaġġ riproduttiv.
English: Because oral contraceptives might possibly not be considered as “effective methods of contraception”, they should be used together with another method, such as a barrier method (see section 4.5).
Maltese: Peress li kontraċettivi orali jistgħu ma jkunux ikkunsidrati bħala “metodi effettivi ta' kontraċezzjoni”, għandhom jintużaw flimkien ma' metodu ieħor, bħal metodu ta' barriera (ara sezzjoni 4.5).
English: CABOMETYX 60 mg film-coated tablets are yellow, oval shaped with no score, and identified with “XL” on one side and “60” on the other side.
Maltese: CABOMETYX 60 mg pilloli miksija b'rita huma sofor, b'forma ovali mingħajr sinjal imnaqqax, u identifikati b'“XL” fuq naħa waħda u “60” fuq in-naħa l-oħra.
English: Juvenile rats (correlating to a <2- year paediatric population) showed similar treatment-related findings but appeared to be more sensitive to cabozantinib-related toxicity at comparable dose levels.
Maltese: Firien frieħ (komparabbli ma' popolazzjoni pedjatrika ta' <sentejn) urew sejbiet simili relatati mat-trattament iżda deheru li huma aktar sensittivi għal tossiċità relatata ma' cabozantinib f'livelli ta' doża komparabbli.
English: How to take CABOMETYX 4.
Maltese: Kif għandek tieħu CABOMETYX 4.
English: The Kaplan- Meier estimates for median duration of OS were 11.1 months in the cabozantinib arm versus 6.9 months in the placebo arm, an estimated 4.2-month difference in the medians.
Maltese: L-istimi Kaplan-Meier għat-tul ta' żmien medjan ta' OS kienu ta' 11.1 xhur fil-grupp ta' cabozantinib kontra 6.9 xhur fil-grupp tal-plaċebo, differenza stmata ta' 4.2 xhur fil-medjani.
English: Urine protein should be monitored regularly during cabozantinib treatment.
Maltese: Il-proteina fl-awrina għandha tiġi mmonitorjata b'mod regolari waqt it-trattament b'cabozantinib.
English: NAME OF THE MEDICINAL PRODUCT CABOMETYX 20 mg film-coated tablets cabozantinib
Maltese: CABOMETYX 20 mg pilloli miksija b'rita cabozantinib ISEM
English: Progression-free survival (PFS) by Investigator Median PFS in months (95% CI) HR (95% CI); stratified b,c Two-sided log-rank p-value: stratified b p=0.0042
Maltese: Sopravivenza mingħajr progressjoni (PFS) mill-Investigatur PFS medjana f'xhur (CI ta' 95%) HR (CI ta' 95%); stratifikat b,c
English: CABOMETYX 20 mg film-coated tablets
Maltese: CABOMETYX 20 mg pilloli miksija b'rita
English: CABOMETYX 60 mg film-coated tablets cabozantinib
Maltese: CABOMETYX 60 mg pilloli miksija b'rita cabozantinib ISEM