FrancophonIA/ELRC3.0 huggingface dataset:
English: Figure 3: Kaplan-Meier Analysis of OS Among Subjects with a RET M918T Mutation
Maltese: Figura 3: Analiżi ta' Kaplan-Meier ta' OS Fost Individwi b'Mutazzjoni M918T ta' RET
English: Overall Response Ratea (95% CI)
Maltese: Rata ta' Rispons Globalia (95% Cl)
English: (1/55)c a Response = CR + PR b Disease Control Rate = SD+ ORR c Includes patients who were evaluable for response
Maltese: (1/55) c a Rispons = CR + PR b Rata ta' Kontroll tal-Marda = SD + ORR c Jinkludi pazjenti li jistgħu jiġu valutati għal rispons
English: Catalent UK Packaging Limited Lancaster Way, Wingates Industrial Park, Westboughton, Bolton, Lancashire, BL5 3XX, United Kingdom
Maltese: Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott Catalent UK Packaging Limited Lancaster Way, Wingates Industrial Park, Westhoughton, Bolton,
English: RET mutation status
Maltese: Stat mutazzjonali RET
English: Capsule shell
Maltese: Kapsuli ibsin
English: There was no improvement in OS for the RET M918T negative and unknown subgroups.
Maltese: Ma kienx hemm titjib fl-OS għall-RET M918T negattiva u sottogruppi negattivi u mhux magħrufa.
English: Component of a 28 day pack, can't be sold separately.
Maltese: Komponent ta' pakkett ta' 28 jum, ma jistax ji mibjugħ sfuż.
English: MRP2 inhibitors
Maltese: Impedituri ta' MRP2
English: Cabozantinib is a CYP3A4 substrate.
Maltese: Cabozantinib hu sottostrat ta' CYP3A4
English: The carcinogenic potential of cabozantinib has been evaluated in two species: rasH2 transgenic mice and Sprague-Dawley rats.
Maltese: Il-potenzjal karċinoġeniku ta 'cabozantinib kienet evalwata f'żewġ speċi: ġrieden transġeniċi rasH2 u firien Sprague-Dawley.
English: A neutralizing antibody to CYP2C9 showed a minimal effect on cabozantinib metabolite formation (ie, a <20% reduction).
Maltese: Antikorp newtralizzanti ta' CYP2C9 wera effett minimu fuq il-formazzjoni ta' metaboliti minn cabozintinib (ie, tnaqqis ta' <20%).
English: Endocrine disorders hypothyroidism
Maltese: Disturbi fissistema endokrinarja ipotajrojdiżmu
English: BATCH NUMBER<, DONATION AND PRODUCT CODES> Lot
Maltese: NUMRU TAL-LOTT <, DONAZZJONI U KOWD TAL-PRODOTT> Lot
English: The median duration of objective responses was 14.6 months (95% CI: 11.1, 17.5) for subjects in the cabozantinib arm.
Maltese: It-tul ta' żmien medjan ta' risponsi oġġettivi kien ta' 14.6 xhur (95% CI 11.1, 17.5 xhur) għal individwi fil-grupp ta' cabozantinib.
English: The objective response rates measured in these subgroups were generally consistent with the PFS results, with the RET mutation positive, negative, and unknown subgroups showing tumour response rates of 32%, 22%, and 25%, respectively.
Maltese: Ir-rati ta' risponsi oġġettivi mkejla f'dawn is-sottogruppi kienu ġeneralment konsistenti mar-riżultati ta' PFS bissottogruppi ta' mutazzjoni pożittiva, negattiva u mhux magħrufa ta' RET juru rati ta' rispons ta tumur ta' 32%, 22% u 25%, rispettivament.
English: A dose-comparison study (XL-184-401) (140 mg vs 60 mg) in 112 patients with hereditary or sporadic medullary thyroid cancer.
Maltese: Studju ta' tqabbil ta' dożi (XL-184-401) (140 mg vs 60 mg) f'112-il pazjent b'kanċer ereditarju jew tat-tirojdi medullari sporadiku.
English: Dose reductions and dose interruptions occurred in 79% and 72%, respectively, of cabozantinib-treated patients in the pivotal clinical trial.
Maltese: Tnaqqis fid-doża u differiment ta' dożi seħħew f'79 % u 72 % rispettivament, ta' pazjenti kkurati b'carbozantinib fil-prova klinika ewlenija.
English: Effect of other medicinal products on cabozantinib
Maltese: L-effett ta' prodotti mediċinali oħra fuq cabozantinib
English: • 100 mg (1 orange 80 mg capsule and 1 grey 20 mg capsule)
Maltese: • 100 mg (kapsula oranġjo 1 ta' 80 mg u kapsula griża 1 ta' 20 mg)
English: RET mutation negative patients with no evidence of RAS mutation (n=33) showed a decreased PFS benefit on cabozantinib (HR of 0.87) and a lower response rate of 18% compared to other mutational subgroups.
Maltese: Mutazzjoni negattiva ta' RET mingħajr evidenza ta' mutazzjoni RAS (n=33) uriet tnaqqis fil-benefiċċju PFS ta' cabozantinib (HR ta' 0.87) u rata ta' rispons aktar baxxa ta' 18% meta mqabbel ma' sottogruppi mutazzjonali.
English: Palmar-plantar erythrodysaesthesia syndrome
Maltese: Sindromu ta' eritrodisestesija ta' palmar-plantar.
English: Perforations, fistulas, and intra-abdominal abscesses
Maltese: Perforazzjonijiet, fistuli u axessi intraddominali.
English: ANNEX II
Maltese: Tabella 2 ).
English: Next generation sequencing of RET exons 10, 11, and 13-16 will be performed, which covers the vast majority of known RET mutations.
Maltese: Ser isiru sekwenzi tal-ġenerazzjoni li jmiss għal RET exons 10, 11, u 13-16, li jkopru l-istramaġġoranza ta' mutazzjonijiet magħrufa ta' RET.
English: Gastrointestinal disorders diarrhoea, nausea, stomatitis, constipation, vomiting, abdominal pain, dyspepsia, dysphagia, glossodynia gastrointestinal perforation, gastrointestinal haemorrhage, pancreatitis, haemorrhoids, anal fissure, anal inflammation, cheilitis gastrointestinal fistula, oesophagitis
Maltese: Disturbi gastrointestinali dijarea, tqalligħ, stomatite, stitikezza, remettar, uġigħ addominali, dispepsja, disfaġja, glossodinja perforazzjoni gastrointestinali, emorraġija gastrointestinali, pankreatite, murliti, fissura anali, infjammazzjoni anali, kejlite fistula gastrointestinali, esofaġite
English: Cabozantinib is a substrate for CYP3A4 metabolism in vitro, as a neutralizing antibody to CYP3A4 inhibited formation of metabolite XL184 N-oxide by >80% in a NADPH-catalyzed human liver microsomal (HLM) incubation; in contrast, neutralizing antibodies to CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C19, CYP2D6 and CYP2E1 had no effect on cabozantinib metabolite formation.
Maltese: N-oxide b'>80% f'inkubazzjoni mikrosomali tal-fwied uman (HLM-Human Liver microsomal) katalizzati b'NADPH: b'kuntrast antikorporali newtralizzanti għal CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C19, CYP2D6 u CYP2E1 ma kellhomx effett fuq formazzjoni ta' metaboliti minn cabozantinib.
English: Events of osteonecrosis of the jaw (ONJ) have been observed with cabozantinib.
Maltese: Każijiet ta' osteonekrosi tax-xedaq (ONJ - osteonecrosis of the jaw) ġew osservati b'cabozantinib.
English: • Infection and inflammation in the lung, collapse of lung
Maltese: • Infezzjoni u infjammazzjoni tal-pulmun; il-pulmun jikkolassa
English: Because of high plasma protein binding levels of cabozantinib (section 5.2) a plasma protein displacement interaction with warfarin may be possible.
Maltese: Minħabba livelli għolja fil-plażma ta 'proteina li jorbtu tal- cabozantinib (sezzjoni 5.2) interazzjoni ta' spostament ta 'proteina plażmatika mal-warfarin tista' tkun possibbli.
English: • 140 mg (1 orange 80 mg capsule and 3 grey 20 mg capsules)
Maltese: • 140 mg (kapsula oranġjo 1 ta' 80 mg u 3 kasuli griżi ta' 20 mg )
English: The ORR was 27.9% and 0% for subjects in the cabozantinib arm and placebo arm, respectively (p<0.0001; Table 2).
Maltese: L-ORR kienet ta' 27.9% u 0% għal individwi fil-grupp ta' cabozantinib u l-grupp tal-plaċebo, rispettivament (p<0.
English: Four metabolites were present in plasma at exposures (AUC) greater than 10% of parent: XL184-N-oxide, XL184 amide cleavage product, XL184 monohydroxy sulfate, and 6-desmethyl amide cleavage product sulfate.
Maltese: Erba' metaboliti huma preżenti fil-plażma f'esponimenti (AUC) akbar minn 10% tal-ġenitur: XL184-N-oxide, XL184 prodott li jifforma mill-qsim ta' amide, XL184 monohydroxy sulfate, u 6-desmethyl prodott li jifforma mill-qsim tal-amide u jifforma sulfate.
English: Cabozantinib was an inhibitor (IC50 = 7.0 μM), but not a substrate, of P-glycoprotein (P-gp) transport activities in a bi-directional assay system using MDCK-MDR1 cells.
Maltese: Cabozantinib kien impeditur (IC50 = 7.0 μM) imma mhux sottostrat, ta' attivitajiet ta' ġarr b'P-glycoprotein (P-gp) f'sistema ta' assaġġ bidirezzjonali permezz ta' ċelluli MDCK-MDR-1.
English: Figure 2: Kaplan-Meier curve of overall survival
Maltese: Kaplan-Meier għal sopravivenza globali
English: 11.2 months
Maltese: 11.2 xhur
English: 14.6 months
Maltese: 14.6 xhur
English: EU/1/13/890/002 7 x 20 mg and 7 x 80 mg capsules (100 mg/day dose for a 7-day supply) EU/1/13/890/003 21 x 20 mg and 7 x 80 mg capsules (140 mg/day dose for a 7-day supply) EU/1/13/890/005 56 capsules (4 blister cards of 7 x 20 mg and 7 x 80 mg) (100 mg/day dose for 28 day supply)
Maltese: EU/1/13/890/002 7 x 20 mg u 7 x 80 mg kapsuli (doża ta' 100 mg/jum għal 7 ijiem) EU/1/13/890/003 21 x 20 mg u 7 x 80 mg kapsuli (doża ta' 140 mg/jum għal 7 ijiem) EU/1/13/890/005 56 kapsula (4 folji ta' kardi ta': 7 x 20 mg u 7 x 80 mg) (doża ta' 100 mg/jum għal 28 jum)
English: • Decrease in the levels of protein in your blood
Maltese: • Tnaqqis fil-livelli ta' proteina fid-demm tiegħek
English: The most common laboratory abnormalities were increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), increased alkaline phosphatase (ALP), lymphopenia, hypocalcaemia, neutropenia, thrombocytopenia, hypophosphataemia, hyperbilirubinemia, hypomagnesaemia, and hypokalaemia.
Maltese: L-aktar abnormalitajiet komuni mir-riżultati tal-laboratorju kienu żieda f'aspartate aminotransferase (AST), żieda f'alanine aminotransferase (ALT), żieda f'alkaline phosphatase (ALP), limfopenja, ipokalċemija, newtropenja, tromboċitopenja, ipofosfatemija, iperbilirubinemija, ipomanjesemija u ipokalimja.
English: A multi-center, randomized double-blind study comparing cabozantinib (N = 219) with placebo (N = 111) was conducted in patients with unresectable locally advanced or metastatic MTC and documented radiographic disease progression within 14 months prior to study entry.
Maltese: Studju multiċentriku, każwali u double-blind li qabbel cabozantinib (N = 219) ma' plaċebo (N = 111) sar f'pazjenti b'MTC lokalment avvanzat li ma setax jitneħħa jew metastatiku u bi progressjoni talmard dokumentat b'mod radjografiku fi żmien 14-il xahar qabel id-dħul fl-istudju.
English: Disease Control Rate b (95% CI) Calcitonin Responsea
Maltese: Rata ta' Kontroll tal-Marda b (95% Cl)
English: Cabozantinib was evaluated for its inhibitory activity against a variety of kinases and was identified as an inhibitor of MET (hepatocyte growth factor receptor protein) and VEGF (vascular endothelial growth factor) receptors.
Maltese: Cabozantinib ġie evalwat għal attività impeditorja tiegħu kontra varjeta ta' kinases u kien identifikat bħala impeditur ta' MET (proteina riċettatur għal fattur tal-iżvilupp ta' epatoċiti) u riċettaturi VEGF (vascular endothelial growth factor - fattur ta' żvilupp andoteljali vaskulari).
English: Cabozantinib has shown no mutagenic or clastogenic potential in a standard battery of genotoxicity assays.
Maltese: Cabozantinib ma wera l-ebda potenzjal mutaġeniku jew klastiġeniku f'batterija standard ta' assaġġi ġenotossiċi.
English: COMETRIQ 20 mg COMETRIQ 80 mg 140 mg/day dose
Maltese: COMETRIQ 20 mg COMETRIQ 80 mg Doża ta' 140 mg/jum
English: Two dose reductions were required in 41% of patients.
Maltese: It-tnaqqis fid-doża kellu jseħħ darbtejn f'41 % tal-pazjenti.
English: Reproductive system and breast disorders amenorrhoea, vaginal haemorrhage
Maltese: Disturbi fissistema riproduttiva u fis-sider amenorea, emorraġija vaġinali
English: A significant improvement in OS was observed in the subgroup of RET M918T mutation positive patients (n=81/219 cabozantinib arm): 44.3 months in the cabozantinib arm vs. 18.9 months in the placebo arm (HR = 0.60, p = 0.0255).
Maltese: Titjib sinifikanti fl-OS ġiet osservata fis-sottogrupp ta' pazjenti b'mutazzjoni pożittiva għal RET M918T (n=81/219 grupp ta' cabozantinib): 44.3 xhur fil-grupp ta' cabozantinib kontra 18.9 fil-grupp tal-plaċebo (HR = 0.60, p = 0.0255).
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: It-teħid tas-sensibilizzatur qawwi ta' CYP3A4 rifampicin (600 mg kuljum għal 31 jum) lil voluntieri b'saħħithom naqqas it-tneħħija ta' cabozantinib (b' 4.3 drabi) u naqqas l-esponiment għal doża unika ta' cabozantinib fil-plażma (AUC) b' 77%.
English: COMETRIQ 20 mg COMETRIQ 80 mg 100 mg/day dose
Maltese: COMETRIQ 20 mg COMETRIQ 80 mg Doża ta' 100 mg/jum
English: Vascular disorders hypertension hypotension, venous thrombosis, pallor, peripheral coldness arterial thrombosis Aneurysms and artery dissections
Maltese: Disturb vaskulari pressjoni għolja pressjoni baxxa, trombosi venuża, sfurija, kesħa periferika trombosi arterjali anewriżmi u dissezzjonijiet tal-arterji
English: • Stroke
Maltese: • Murliti
English: • Abnormal connection of the tissue in your trachea (airway), oesophagus, or lungs
Maltese: • Konnessjoni abnormali tat-tessut fit-trakea (passaġġ tal-arja), l-esofagu, jew il-pulmun
English: Other medicines and COMETRIQ
Maltese: Mediċini oħra u COMETRIQ
English: Psychiatric disorders anxiety, depression, confusional state abnormal dreams, delirium
Maltese: Disturbi psikjatriċi ansjetà, depressjoni. stat konfużjonali,
English: Administration of the strong CYP3A4 inhibitor ketoconazole (400 mg daily for 27 days) to healthy volunteers decreased cabozantinib clearance (by 29%) and increased single-dose plasma cabozantinib exposure (AUC) by 38%.
Maltese: It-teħid ta' impeditur qawwi ta' CYP3A4 ketoconazole (400 mg kuljum għal 27 jum) lil voluntieri b'saħħithom naqqas it-tneħħija ta' cabozantinib (b' 29%) u żied l-esponiment għal doża unika ta' cabozantinib fil-plażma (AUC) bi 38%.
English: Cabozantinib treatment should be stopped at least 28 days prior to scheduled surgery, if possible.
Maltese: It-trattament b'cabozantinib għandu jitwaqqaf tal-anqas 28 jum qabel l-intervent kirurġiku skedat, jekk possibbli.
English: Reversible Posterior Leukoencephalopathy Syndrome (RPLS), also known as Posterior Reversible Encephalopathy Syndrome (PRES) has been observed with cabozantinib.
Maltese: Is-Sindromu ta' Lewkoenċefalopatija Posterjuri Riversibbli (RPLS-Reverse Posterior Encephalopathy Syndrome) magħruf ukoll bħala s-Sindromu ta' Enċefalopatija Riversibbli Posterjuri (PRESPosterior Reversible Encephalopathy Syndrome) ġie osservat b'cabozantinib.
English: Two non-conjugated metabolites (XL184-N-oxide and XL184 amide cleavage product), which possess <1% of the on-target kinase inhibition potency of parent cabozantinib, each represent <10% of total drug-related plasma exposure.
Maltese: Żewġ metaboliti mhux konjugati (XL184-N-oxide u XL184 prodott li jifforma mill-qsim ta' amide), li jipposedi <1% tal-qawwa impeditorja fuq il-bersall tal-kinase tal-ġenitur cabozantinib, b'kull wieħed jirrapreżenta <10% tal-esponiment totali tal-mediċina fil-plażma.
English: For invasive dental procedures, cabozantinib treatment should be held at least 28 days prior to scheduled surgery, if possible.
Maltese: Għal proċeduri dentali invażivi, it-trattament b'cabozantinib għandu jitwaqqaf għal mill-inqas 28 jum qabel l-intervent kirurġiku skedat, jekk possibbli.
English: The final analysis of OS was conducted after 218 events (deaths) occurred and shows a trend for an increase in median survival of 5.5 months in the cabozantinib arm: median (months) 26.6 cabozantinib vs. 21.1 placebo (HR = 0.85 [95% CI: 0.64, 1.12], p = 0.2409).
Maltese: L-analiżi finali ta' sopravivenza globali (overall survival, OS) saret wara li kienu seħħew 218-il każ (imwiet) u turi xejra f'żieda fis-sopravivenza medjana ta' 5.5 xhur fil-grupp ta' cabozantinib: medjan (xhur) 26.6 cabozantinib kontra plaċebo 21.1 (HR = 0.85 [95% CI: 0.64, 1.12], p = 0.2409).
English: In addition, cabozantinib inhibits other tyrosine kinases including RET, the GAS6 receptor (AXL), the stem cell factor receptor (KIT), and Fms-like tyrosine kinase-3 (FLT3).
Maltese: Barra minn hekk, cabozantinib jimpedixxi kinases ta' tyrosine oħra li jinkludu RET, ir-riċettatur GAS6 (AXL), ir-riċettatur ta' ċelluli steminali (KIT) u tyrosine kinase-3 bħal Fms (FLT3 - Fms like tyrosine kinase 3).
English: 84 capsules (4 blister cards of 21 x 20 mg) (60 mg/day dose) 56 capsules (4 blister cards of 7 x 20 mg and 7 x 80 mg) (100 mg/day dose) 112 capsules (4 blister cards of 21 x 20 mg and 7 x 80 mg) (140 mg/day dose)
Maltese: 84 kapsula (kartun b'4 folji ta': 21 x 20 mg) (doża ta' 60 mg/jum) 56 kapsula (kartun b'4 folji ta': 7 x 20 u 7 x 80 mg) (doża ta' 100 mg/jum) 112-il kapsula (kartun b'4 folji ta': 21 x 20 mg u 7 x 80 mg) (doża ta' 140 mg/jum)
English: Cabozantinib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs) implicated in tumour growth and angiogenesis, pathologic bone remodeling, and metastatic progression of cancer.
Maltese: Cabozantinib huwa molekula żgħira li timpedixxi riċettaturi multipli ta' tyrosine kinases (RTKsreceptor throsine kinases) implikati fl-iżvilupp ta' tumur u anġjoġenesi, remodellar patoġeniku talgħadam u progressjoni metastatika ta' kanċer.
English: Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitor, ATC code: L01XE26.
Maltese: Kategorija farmakoterapewtika: sustanza antineoplastika, impeditur tal-proteina kinase.
English: No cabozantinib-treated subjects had a QTcF >500 ms.
Maltese: L-ebda individiwu kkurat b'cabozantinab ma kellu QTcF >500 ms.
English: Clinical data in medullary thyroid cancer
Maltese: Tagħrif kliniku f'kanċer medullari tat-tirojdi
English: Respiratory, thoracic, and mediastinal disorders dysphonia, oropharyngeal pain non-gastrointestinal fistula (including tracheal, pneumomediastinu m, tracheooesophageal), pulmonary embolism, respiratory tract haemorrhage (including pulmonary, bronchial, tracheal), pneumonia aspiration atelectasis, pharyngeal oedema, pneumonitis
Maltese: Disturbi respiratorji, toraċiċi u medjastinali disfonja, uġigħ orofarinġeali fistula mhux gastrointestinali (li jinkludi trakeali, pnewmomedjastinum, trakeo-esofaġeali), emboliżmu pulmonari, emorraġija fil-passaġġ respiratorju (li jinkludi pulmonarju, bronkjali, trakeali) aspirazzjoni pnewmonika atelektasi, edema farinġeali, pnewmonite
English: Urine protein should be monitored regularly during cabozantinib treatment.
Maltese: Il-proteina fl-awrina għandha tiġi monitorata regolarment waqt it-trattament b'cabozantinib.
English: Events of venous thromboembolism and events of arterial thromboembolism have been observed with cabozantinib.
Maltese: Każijiet ta' tromboemboliżmu venuż u każijiet ta' tromboemboliżmu arterjali ġew osservati b'cabozantinib.
English: COMETRIQ 20 mg hard capsules COMETRIQ 80 mg hard capsules
Maltese: COMETRIQ 20 mg kapsuli ibsin COMETRIQ 80 mg kapsuli ibsin
English: How to store COMETRIQ 6.
Maltese: Kif taħżen COMETRIQ 6.
English: COMETRIQ 80 mg capsules are orange and have “XL184 80mg” printed on one side.
Maltese: Il-kapsuli ta' COMETRIQ 80 mg huma oranġjo u għandhom "XL184 80mg" stampat fuq naħa minnhom.
English: COMETRIQ 20 mg hard capsules Cabozantinib
Maltese: COMETRIQ 20 mg kapsuli ibsin Cabozantinib DIKJARAZZJONI
English: Musculoskeletal and connective tissue disorders arthralgia, muscle spasms, pain in extremity musculoskeletal chest pain, osteonecrosis of jaw rhabdomyolysis
Maltese: Disturbi muskoluskeletriċi u tattessuti konnettivi artralġja, spażmi muskolari, uġigħ f'estremità uġigħ muskoluskeletriku fis-sider, osteonekrosi tax-xedaq rabdomijolosi
English: The resulting DNA samples will be evaluated for quality by a PCR-based amplification test, and by Sanger sequencing for RET M918T.
Maltese: Il-kampjuni tad-DNA li jirriżultaw ser jiġu evalwati għal kwalità b'test ta' amplifikazzjoni bażat fuq PCR, u b'sekwenzi ta' Sanger għal RET M918T.
English: Of the 215 subjects with sufficient data to determine mutational status, 78.6% (n=169) were classified as RET mutation positive (126 of which were positive for the M918T mutation), and 21.4% (n=46) were classified as RET mutation negative.
Maltese: Mill-215-il individwu b'tagħrif suffiċjenti biex jiġi stabbilit l-istat mutazzjonali, 78.6% (n=169) kienu klassifikati bħala RET pożittivi għal mutazzjoni, (126 li kienu pożittivi għall-mutazzjoni M918T), u 21.4% (n=46) kienu klassifikati bħala RET negattivi għal mutazzjoni.
English: 140 mg Dose
Maltese: Doża ta' 140 mg
English: Hard capsules 20 mg
Maltese: tliet kapsuli griżi ta' 20 mg
English: As unchanged contraceptive effect may not be guaranteed, an additional contraceptive method, such as a barrier method, is recommended.
Maltese: Peress li l-effett kontraċettiv mhux mibdul ma jistax jiġi garantit, metodu ta' kontraċezzjoni addizzjonali, bħal metodu ta' barriera, huwa rakkomandat.
English: PVC/PE/PCTFE-Al blisters with foil backing, sealed into a secondary heat-sealed card packaging.
Maltese: Folji tal-PVC/PE/PCTFE-Al mgħottija bil-fojl fuq wara, isiġillati f'pakkett b'kard sekondarju fissħana.
English: EU/1/13/890/006 112 capsules (4 blister cards of 21 x 20mg and 7 x 80 mg) (140 mg/day dose for 28
Maltese: EU/1/13/890/006 112-il kapsula (4 folji ta' kards ta' 21 x 20 mg u 7 x 80 mg) (doża ta'
English: • Stopping menstruation, vaginal bleeding
Maltese: • Waqfien tal-menstruazzjoni, emorraġija vaġinali
English: Subjects should be cautioned regarding taking a P-gp substrate (e.g., fexofenadine, aliskiren, ambrisentan, dabigatran etexilate, digoxin, colchicine, maraviroc, posaconazole, ranolazine, saxagliptin, sitagliptin, talinolol, tolvaptan) while receiving cabozantinib.
Maltese: Individwi għandhom jiġu mwissija dwar it-teħid ta' sottostrat ta' P-gp (eż. fexofenadine, aliskiren, ambrisentan, dabigatran etexilate, digoxin, colchicine, maraviroc, posaconazole, ranolazine, saxagliptin, sitagliptin, talinolol, tolvaptan) waqt li jkunu qed jieħdu cabozantinib).
English: Serious GI perforations and fistulas, sometimes fatal, and intra-abdominal abscesses have been observed with cabozantinib.
Maltese: Perforazzjonijiet GI u fistuli serji, xi kultant fatali, u axessi intraddominali ġew osservati b'cabozantinib.
English: The secondary objectives were to compare overall response rate (ORR) and overall survival (OS).
Maltese: L-oġġettivi sekondarji kienu sabiex titqabbel ir-rata ta' rispons globali (ORR - overall response rate) ma' sopravivenza globali (OSoverall survival).
English: COMETRIQ capsules are packaged in blister cards organised by prescribed dose.
Maltese: Il-kapsuli COMETRIQ huma ppakkettati f'folji fil-kartuni organizzati bid-doża preskritta.
English: EU/1/13/890/001 21 x 20 mg capsules (60 mg/day dose for a 7-day supply) EU/1/13/890/004 84 capsules (4 blister cards of 21 x 20 mg) (60 mg/day dose for a 28 day supply)
Maltese: EU/1/13/890/001 21 x 20 mg kapsula (doża ta' 60 mg/jum għal forniment ta' 7 ijiem) EU/1/13/890/004 84 kapsula (4 folji ta' kards ta' 21 x 20 mg) (doża ta' 60 mg/jum għal fornimemt ta' 28 jum)
English: The result of the PFS analysis, based on the central review RECIST assessment, demonstrated a statistically significant difference in the duration of PFS with cabozantinib versus placebo: the median duration was 11.2 months for subjects in the cabozantinib arm versus 4.0 months for subjects in the placebo arm (stratified Hazard Ratio [HR] = 0.28; 95% CI: 0.19, 0.40; p<0.0001; Figure 1).
Maltese: Ir-riżultat tal-analiżi ta' PFS, bażati fuq il-valutazzjoni RECIST b'reviżjoni ċentrali, wera differenza statistikament sinifikanti fit-titwil ta' żmien ta' PFS b'cabozantinib meta mqabbel ma' plaċebo, it-tul ta' żmien medjan ikun ta' 11.2 xahar għal individwi fil-grupp ta' cabozantinib kontra 4.0 xhur għal individwi fil-grupp tal-plaċebo (proporzjon ta' periklu stratifikat [HR] = 0.28 95% CI 0.19 0.40 p<0.
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 impedituri qawwija ta' CYP3A4 għandhom jintużaw b'kawtela, u l-użu kroniku ta' prodotti mediċinali li jittieħdu fl-istess waqt li huma sensibilizzaturi ta' CYP3A4 għandhom jiġu evitati (ara sezzjonjiet 4.4 u 4.5).
English: Record date of first dose.
Maltese: DATA TA' REVIŻJONI TAT-TEST