FrancophonIA/ELRC3.0 huggingface dataset:
English: Men being treated with cladribine should be advised not to father a child up to 6 months after treatment and to seek advice of cryoconservation of sperm prior to treatment because of the possibility of infertility due to therapy with cladribine (see sections 4.6 and 5.3).
Maltese: Għandu jkun rakkomandat li rġiel li qed ikunu ttrattati bi cladribine ma jnisslux tfal sa 6 xhur wara ttrattament u biex jieħdu parir dwar il-konservazzjoni krijoġenika ta' l-isperma qabel it-trattament, minħabba l-possibbiltà ta' infertilità minħabba t-terapija bi cladribine (ara sezzjonijiet 4.6 u 5.3).
English: Very rare: cholecystitis
Maltese: Mhux komuni: kakessija
English: Concomitant use of other myelosuppressive medicinal products.
Maltese: GĦAR-RIMI TA' PRODOTTI MEDIĊINALI MHUX
English: Cell death occurs from energy depletion and apoptosis.
Maltese: Il-mewt taċ-ċelluli sseħħ minħabba n-nuqqas ta' enerġija u apoptożi.
English: Cytotoxic medicinal products should be handled with caution.
Maltese: Il-prodotti mediċinali ċitoġeniċi għandhom ikunu maniġġati b'attenzjoni.
English: Immediate discontinuation of therapy, careful observation, and initiation of appropriate supportive measures (blood transfusions, dialysis, haemofiltration, anti-infectious therapy, etc.) are the indicated treatment of overdose of cladribine.
Maltese: Waqfien minnufih tat-terapija, osservazzjoni b'attenzjoni, u l-bidu ta' miżuri ta' appoġġ xierqa (trasfużjonijiet tad-demm, dijaliżi, filtrazzjoni ematika, terapija antiinfettiva, eċċ.) huma t-trattament indikat għall- doża eċċessiva bi cladribine.
English: Common: second malignancies * Rare: tumour lysis syndrome *
Maltese: Komuni: Tmuri malinni jerġgħu joħorġu għat-tieni darba* Rari: sindrome tat-tumur tal-lisi *
English: OUTER CARTON (5-VIAL PACK)
Maltese: Prekawzjonijiet speċjali għall-ħażna (ara l-fuljett fil-pakkett)
English: Cytotoxic
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: The origin of febrile events should be investigated by appropriate laboratory and radiologic tests.
Maltese: L-oriġini ta' każijiet ta' deni għandhom ikunu investigati b'testijiet tal-laboratorju adattati u testijiet radjoloġiċi.
English: 5 vials each containing 5 ml solution for injection
Maltese: U KONTENUT Kunjett wieħed fih 5 ml ta' soluzzjoni għall-injezzjoni
English: The recommended posology for hairy cell leukaemia is a single course of LITAK given by subcutaneous bolus injection at a daily dose of 0.14 mg/kg body weight for 5 consecutive days.
Maltese: Il-pożoloġija rakkomandata għall-lewkimja taċ-ċelluli ċiljati huwa kors wieħed ta' LITAK mogħti b'injezzjoni taħt il-ġilda b'doża ta' kuljum ta' 0.14 mg/kull kg tal-piż tal-ġisem għal ħamest ijiem konsekuttivi.
English: Stroke.
Maltese: TIKKETTAR
English: Increased number of certain white blood cells (eosinophils).
Maltese: Żieda fin-numru ta' ċerti ċelluli bojod tad-demm (eosinofili).
English: - The other ingredients are sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid
Maltese: - Is-sustanzi l-oħra huma sodium chloride, sodium hydroxide (għall-aġġustament tal-pH), hydrochloric acid (għall-aġġustament tal-pH) u ilma għall-injezzjonijiet.
English: There are no studies available using cladribine in patients with renal or hepatic impairment (see also section 4.2 and section 4.4).
Maltese: Ir-riskju jeħtieġ evalwazzjoni fuq bażi individwali (ara sezzjoni 4.2).
English: Very rare: depression, epileptic seizure
Maltese: Rari ħafna: dipressjoni, attakk ta' puplesija
English: It is recommended that patients receiving cladribine should receive irradiated cellular blood components/products to prevent transfusion-related graft-versus-host disease (Ta-GVHD).
Maltese: Huwa rakkomandat li pazjenti li qed jirċievu cladribine għandhom jirċievu komponenti/prodotti taddemm irradjati biex mard relatat mat-trasfużjoni, (Ta-GVHD: graft-versus-host-disease) ikun evitat.
English: Cladribine shows complete bioavailability after parenteral administration; the mean area under the plasma concentration versus time curve (AUC) is comparable after continuous or intermittent 2-hour intravenous infusion and after subcutaneous injection.
Maltese: Clabridine juri biodisponibilità kompleta fil-ġisem wara l-għoti b'injezzjoni; l-erja medja taħt il-kurva tal-konċentrazzjoni tal-plażma kontra l-ħin (AUC) fil-plażma hija komparabbli wara infużjoni kontinwa jew intermittenti fil-vini mogħtija kull sagħtejn, u wara injezzjoni fit-tessut taħt il-ġilda.
English: Further rare cases with fatal outcome, reported in association with LITAK chemotherapy, were second malignancy, cerebro- and cardiovascular infarctions, graft-versus-host disease caused by multiple transfusions of non-irradiated blood, as well as tumour lysis syndrome with hyperuricaemia, metabolic acidosis, and acute renal failure.
Maltese: Każijiet oħra rari li kienu fatali, irrappurtati li kienu assoċjati mal-kemoterapija b'LITAK, kienu tumuri malinni li reġgħu żviluppaw, infart tal-moħħ u kardjovaskulari, mard tal-graftversus-host kawżat bi trasfużjonijiet multipli ta' demm mhux irradjat, kif ukoll is-sindrome tal-lisi tattumur b'iperurikemija, aċidosi metabolika u ħsara akuta fil-kliewi.
English: Sore throat.
Maltese: Tqala u treddigħ.
English: Patients less than 18 years of age.
Maltese: Pazjenti li għandhom inqas minn 18-il sena.
English: In the clinical trial using LITAK subcutaneously, 63 patients with hairy cell leukaemia (33 newly diagnosed patients and 30 patients with relapsed or progressive disease) were treated.
Maltese: Fil-prova klinika bl-użu ta' LITAK taħt il-ġilda, 63 pazjent b'lewkimja taċ-ċelluli ċiljati (33 pazjent ġodda li kienu ddijanjostikati u 30 pazjent b'marda li rkadiet jew b'marda progressiva) kienu kkurati.
English: In patients with a high tumour burden, prophylactic allopurinol therapy to control serum levels of uric acid, together with adequate or increased hydration, should be commenced 24 hours before the start of chemotherapy.
Maltese: F'pazjenti li għandhom tumur aktar kiefer, it-terapija bl-allopurinol profilattiku biex tikkontrolla llivelli ta' l-uric acid fis-serum, flimkien ma' idratazzjoni adegwata jew miżjuda, għandha tinbeda 24 siegħa qabel l-bidu tal-kemjoterapija.
English: The recovery of cytotoxic T-lymphocytes and natural killer cells occurs within 3 to 12 months.
Maltese: L-irkupru tal-limfoċiti-T ċitotossiċi u taċ-ċelluli ‘natural killers' iseħħ fi żmien bejn 3 sa 12-il xahar.
English: Packs contain 1 or 5 vials, each with 5 ml of solution.
Maltese: Il-pakketti fihom kunjett 1 jew 5 kunjetti, li f'kull wieħed hemm soluzzjoni ta' 5 ml.
English: Very common: decreased appetite Uncommon: cachexia
Maltese: Komuni ħafna: nuqqas t'aptit
English: The renal excretion of unmetabolised cladribine occurs within 24 hours and accounts for 15% and 18% of the dose after 2-hour intravenous and subcutaneous administration, respectively.
Maltese: It-tneħħija ta' cladribine mhux metabolizzat isseħħ fi żmien 24 siegħa u tkopri 15% u 18% tad-dożà wara għoti fil-vini ta' sagħtejn u għoti taħt ilġilda rispettivament.
English: What should I do before I give myself a subcutaneous injection of LITAK?
Maltese: Kif għandi nipprepara l-injezzjoni?
English: Be sure that the tip of the needle is in the solution.
Maltese: Jista' jkun li mhux id-daqsijiet kollha jkunu għal skop kummerċjali.
English: Men being treated with cladribine should be advised not to father a child up to 6 months after treatment and to seek advice of cryoconservation of sperm prior to treatment because of the possibility of infertility due to therapy with cladribine (see section 4.4).
Maltese: Irġiel li jkunu qed jiġu kkurati bi cladribine għandhom jiġu avżati biex ma jnisslux tfal sa 6 xhur wara l-kura u biex jieħdu parir dwar il-konservazzjoni krijoġenika tal-isperma qabel il-kura minħabba lpossibbilità ta' infertilità minħabba t-terapija bi cladribine (ara sezzjoni 4.4).
English: Cladribine is moderately acutely toxic to mice, with an LD50 of 150 mg/kg by intraperitoneal administration.
Maltese: 5.3 Tagħrif ta' qabel l-użu kliniku dwar is-sigurtà Clabridine huwa moderatament tossiku b'mod akut fil-ġrieden, b'LD50 ta' 150 mg/kg b'għoti intraperitonali.
English: Cladribine is a cytostatic agent.
Maltese: OĦRA, JEKK MEĦTIEĠA Ċitotossiku.
English: Common: shortness of breath, pulmonary interstitial infiltrates mostly due to infectious aetiology, mucositis Uncommon: pharyngitis
Maltese: Komuni: qtugħ ta' nifs, infiltrati interstizjali pulmonari, laktar minħabba etjoloġija infettiva, mukosite Mhux komuni: farinġite
English: Male: 82%
Maltese: Irġiel: 82%
English: 4879 AC Etten-Leur The Netherlands
Maltese: 4879 AC Etten-Leur In-Netherlands
English: Median age: 64 years.
Maltese: Età medjana: 64 sena.
English: Treatment Modification
Maltese: Modifika fit-Trattament
English: Caucasian: 56%, Asian: 34%
Maltese: Kawkasi: 56%, Asjatiċi: 34%
English: 1 stratified log-rank test
Maltese: 1 test log-rank stratifikat
English: Placebo (N=237)
Maltese: Plaċebo (N=237)
English: 4 stratified Cochran-Mantel-Haenszel (CMH) test
Maltese: 4 test ta' Cochran-Mantel-Haenszel (CMH) stratifikat
English: Number at risk:
Maltese: Numru f'riskju:
English: Ipsen Portugal - Produtos Farmacêuticos S.A. Alameda Fernão Lopes, n° 16A - 1°B 1495 - 190 Algés
Maltese: Alameda Fernão Lopes, n° 16A - 1°B 1495 - 190 Algés
English: Events were Grade 4 and 5.
Maltese: L-avvenimenti kienu ta' Grad 4 u 5.
English: HR (95% CI); stratified b,c
Maltese: HR (CI ta' 95%); stratifikat b,c
English: Complete responses (CR) Partial responses (PR) ORR (CR+PR)) p-value1,4
Maltese: Rispons sħiħ (CR) Rispons parzjali (PR) ORR (CR+PR)) valur p1,4
English: Cabozantinib is highly protein bound in vitro in human plasma (≥ 99.7%).
Maltese: Cabozantinib huwa marbut ħafna mal-proteini in vitro fil-plażma umana (≥ 99.7%).
English: There is limited data in patients with moderate hepatic impairment (n=15) as per NCI-ODWG (National Cancer Institute - Organ Dysfunction working Group) criteria.
Maltese: Hemm data limitata f'pazjenti b'indeboliment moderat tal-fwied (n=15) skont il kriterji ta' NCI-ODWG (National Cancer Institute - Organ Dysfunction working Group).
English: Objective Response Rate n (%)3
Maltese: Rata ta' Rispons Oġġettiv n (%)3
English: Patheon France 40 Boulevard de Champaret 38300 Bourgoin-Jallieu FRANCE
Maltese: Patheon France 40 Boulevard de Champaret 38300 Bourgoin-Jallieu FRANZA
English: There are no data on human fertility.
Maltese: Mhemmx data dwar il-fertilità umana.
English: Interrupt treatment until the adverse reaction resolves to Grade ≤1.
Maltese: Waqqaf it-trattament sakemm ir-reazzjoni avversa tonqos għal Grade ≤1.
English: Table 6: Efficacy results in HCC (ITT population, CELESTIAL) CABOMETYX (N=470)
Maltese: Tabella 6: Riżultati tal-effikaċja f'HCC (popolazzjoni b'ITT, CELESTIAL) CABOMETYX (N=470)
English: Aetiology for HCC included 38% hepatitis B virus (HBV), 21% hepatitis C virus (HCV), 40% other (neither HBV nor HCV).
Maltese: Etjoloġija għal HCC kienet tinkludi 38% virus tal-epatite B (HBV - hepatitis B virus), 21% virus talepatite C (HCV - hepatitis C virus), 40% oħrajn (la HBV u lanqas HCV).
English: • Decrease in levels of; calcium, sodium and phosphate in the blood
Maltese: • Tnaqqis fil-livelli ta' calcium, sodium u phosphate fid-demm
English: Danmark, Norge, Suomi/Finland, Sverige, Ísland
Maltese: Danmark, Norge, Suomi/Finland, Sverige, Ísland Magyarország Institut Produits Synthèse (IPSEN) AB
English: Film-coating Hypromellose 2910 Titanium dioxide (E171) Triacetin
Maltese: Titanium dioxide (E171) Triacetin
English: Fistulas
Maltese: Fistuli
English: Palmar-plantar erythrodysaesthesia syndrome (PPES) has been observed with cabozantinib.
Maltese: Is-sindrome ta' eritrodisasteżija palmari-plantari (PPES - palmar-plantar erythrodysaesthesia syndrome) ġiet osservata b'cabozantinib.
English: Patient distribution by IMDC risk groups was 81% intermediate (1-2 risk factors) and 19% poor (≥3 risk factors).
Maltese: Id-distribuzzjoni talpazjenti skont il-gruppi ta' riskju ta' IMDC kienet 81% intermedju (1-2 fatturi ta' riskju) u 19% baxx (≥3 fatturi ta' riskju).
English: Tablet content Microcrystalline cellulose Anhydrous lactose Hydroxypropyl cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
Maltese: Kontenut tal-pillola Microcrystalline cellulose Anhydrous lactose Hydroxypropyl cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
English: Reversible Posterior Leukoencephalopathy Syndrome (RPLS)
Maltese: reversible posterior leukoencephalopathy syndrome).
English: Δημητρίου 63 Άλιμος GR-17456 Αθήνα Ελλάδα Τηλ: + 30 - 210 - 984 3324
Maltese: Αθήνα Ελλάδα Τηλ: + 30 - 210 - 984 3324
English: Interrupt treatment.
Maltese: Waqqaf it-trattament.
English: CABOMETYX Placebo
Maltese: CABOMETYX Plaċebo
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09 September 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 9 ta' Settembru 2016
English: Primary Analysis ORR IntentTo-Treat Population (IRC)
Maltese: Analiżi Primarja ta' ORR ta' Popolazzjoni b'Intenzjoni Li Tiġi Ttrattata (IRC)
English: Diarrhoea led to dose modifications, interruptions and discontinuations in 84/467 (18%), 69/467 (15%) and 5/467 (1%) of subjects, respectively.
Maltese: Id-dijarea wasslet għal modifiki, interruzzjonijiet u waqfien tad-doża f'84/467 (18%), 69/467 (15%) u 5/467 (1%) tal-individwi, rispettivament.
English: P-glycoprotein substrates
Maltese: Sottostrati tal-glikoproteina P
English: Gastrointestinal (GI) perforation
Maltese: Perforazzjoni gastrointestinali (GI - Gastrointestinal)
English: Each film-coated tablet contains 31.07 mg lactose.
Maltese: Kull pillola miksija b'rita fiha 31.07 mg lactose.
English: As unchanged contraceptive effect may not be guaranteed, an additional contraceptive method, such as a barrier method, is recommended.
Maltese: Peress li effett kontraċettiv mhux mibdul ma jistax jiġi garantit, huwa rakkomandat metodu ta' kontraċezzjoni addizzjonali, bħal metodu ta' barriera.
English: Al. Jana Pawła II 29 Selise 26-11,
Maltese: Jana Pawła II 29
English: MRP2 inhibitors
Maltese: Inibituri ta' MRP2
English: • A wound that does not heal.
Maltese: • Ferita li ma tfieqx.
English: Adverse reactions are listed in Table 2 according to MedDRA System Organ Class and frequency categories.
Maltese: Ir-reazzjonijiet avversi huma elenkati f'Tabella 2 skont is-Sistema tal-Klassifika tal-Organi ta' MedDRA u kategoriji ta' frekwenza.
English: Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitor, ATC code: L01XE26.
Maltese: Kategorija farmakoterapewtika: sustanza antineoplastika, inibitur ta' protein kinase, Kodiċi ATC:
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 inibit minn CYP3A4 b'>80% f'inkubazzjoni ta' mikrosomi talfwied uman (HLM - human liver microsomal) katalizzata minn NADPH; b'kuntrast, antikorpi newtralizzanti għal CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C19, CYP2D6 u CYP2E1 ma kellhom l-ebda effett fuq il-formazzjoni ta' metaboliti ta' cabozantinib.
English: CABOMETYX contains lactose (a type of sugar).
Maltese: CABOMETYX fih lactose (tip a zokkor).
English: In vitro data demonstrate that cabozantinib is a substrate of MRP2.
Maltese: Data in vitro turi li cabozantinib huwa sottostrat ta' MRP2.
English: Figure 4: Kaplan-Meier curve of overall survival (CELESTIAL)
Maltese: Kaplan-Meier ta' sopravivenza globali (CELESTIAL)
English: Gastrointestinal (GI) disorders
Maltese: Disturbi gastrointestinali (GI - gastrointestinal)
English: The other ingredients are: - Tablet contents: microcrystalline cellulose, lactose anhydrous, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide anhydrous, magnesium stearate.
Maltese: - Kontenut tal-pillola: microcrystalline cellulose, lactose anhydrous, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide anhydrous, magnesium stearate.
English: Hepatocellular Carcinoma (HCC)
Maltese: Karċinoma Epatoċellulari (HCC - hepatocellular carcinoma)
English: Most patients (87%) had ECOG performance status of 0 or 1; 13% had an ECOG performance status of 2.
Maltese: Il-maġġoranza tal-pazjenti (87%) kellhom stat ta' prestazzjoni ta' ECOG ta' 0 jew 1; 13% kellhom stat ta' prestazzjoni ta' ECOG ta' 2.
English: • Protein in urine (seen in tests)
Maltese: • Proteina fl-awrina (osservata fit-testijiet)
English: A planned interim analysis of OS was conducted at the time of the PFS analysis and did not reach the interim boundary for statistical significance (202 events, HR=0.68 [0.51, 0.90], p=0.006).
Maltese: Analiżi interim ippjanata ta' OS twettqet fil-ħin tal-analiżi ta' PFS u ma ntlaħaqx il-konfini interim għal sinifikanza statistika (202 avvenimenti, HR=0.68 [0.51, 0.90], p=0.006).
English: Cabozantinib treatment should be stopped at least 28 days prior to scheduled surgery, including dental surgery, if possible.
Maltese: Jekk possibbli t-trattament b'cabozantinib għandu jitwaqqaf tal-anqas 28 ġurnata qabel kirurġija skedata, inkluża kirurġija dentali.
English: Note: Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4)
Maltese: Nota: Il-gradi tat-tossiċità huma skont il-Kriterji ta' Terminoloġija Komuni għal Avvenimenti Avversi talIstitut Nazzjonali tal-Kanċer Verżjoni 4.0 (NCI-CTCAE v4 - National Cancer Institute Common
English: A statistically significant improvement in PFS was demonstrated for CABOMETYX compared to everolimus (Figure 1 and Table 3).
Maltese: Titjib statistikament sinifikanti f'PFS intwera għal CABOMETYX meta mqabbel ma' everolimus (Figura 1 u Tabella 3).
English: Exploratory analyses of PFS and OS in the ITT population have also shown consistent results in favour of CABOMETYX compared to everolimus across different subgroups according to age (<65 vs. ≥65, sex, MSKCC risk group (favourable, intermediate, poor), ECOG status (0 vs. 1), time from diagnosis to randomisation (<1 year vs. ≥1 year), tumour MET status (high vs. low vs. unknown), bone metastases (absence vs. presence), visceral metastases (absence vs. presence), visceral and bone metastases (absence vs. presence), number of prior VEGFR-TKIs (1 vs. ≥2), duration of first VEGFRTKI (≤6 months vs. >6 months).
Maltese: Analiżi esploratorja ta' PFS u OS fil-popolazzjoni ITT uriet ukoll riżultati konsistenti favur CABOMETYX meta mqabbel ma' everolimus tul sottogruppi differenti skont l-età (<65 kontra ≥65, sess, grupp ta' riskju MSKCC (favorevoli, intermedju, baxx), stat ta' ECOG (0 kontra 1), żmien mid-dijanjosi sa randomisation (<sena kontra ≥sena), l-istat MET tat-tumur (għoli kontra baxx kontra mhux magħruf), metastasi fl-għadam (nuqqas kontra preżenza), metastasi fil-vixxri (nuqqas kontra preżenza), metastasi fil-vixxri u fl-għadma (nuqqas kontra preżenza), numru ta' VEGFR-TKIs minn qabel (1 kontra ≥2), tul tal-ewwel VEGFR-TKI (≤6 xhur kontra >6 xhur).
English: Table 2: Adverse drug reactions (ADRs) reported in clinical trials in patients treated with cabozantinib
Maltese: Tabella 2: Reazzjonijiet avversi tal-mediċina (ADRs - adverse drug reactions) irrappurtati fi provi kliniċi f'pazjenti ttrattati b'cabozantinib
English: Patients (N=658) with advanced RCC with a clear cell component who had previously received at least 1 prior VEGF receptor tyrosine kinase inhibitor (VEGFR TKI) were randomized (1:1) to receive CABOMETYX (N=330) or everolimus (N=328).
Maltese: Pazjenti (N=658) b'RCC avanzata b'komponent ta' ċelluli ċari li kienu rċevew minn qabel mill-inqas inibitur ta' tyrosine kinase tar-riċettur ta' VEGF (VEGFR TKI - VEGF receptor tyrosine kinase inhibitor) wieħed kienu randomised (1:1) biex jirċievu CABOMETYX (N=330) jew everolimus (N=328).
English: Kaplan-Meier landmark estimates of percent of subjects event-free at 3 months % (95% CI)
Maltese: Stimi ta' riferiment Kaplan-Meier ta' perċentwali ta' individwi mingħajr avveniment wara 3 xhur % (CI ta' 95%)
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 ta' cabozintinib (jiġifieri, tnaqqis ta' <20%).
English: Progression-free survival (PFS) by IRC a Median PFS in months (95% CI) HR (95% CI); stratified b,c Two-sided log-rank p-value: stratified b p=0.0005
Maltese: Sopravivenza mingħajr progressjoni (PFS) minn IRC a PFS medjana f'xhur (CI ta' 95%) HR (CI ta' 95%); stratifikat b,c Valur-p log-rank b'żewġ naħat: stratifikat b p=0.0005
English: In the HCC study (CELESTIAL), portal vein thrombosis was observed with cabozantinib, including one fatal event.
Maltese: Fl-istudju dwar HCC (CELESTIAL), trombożi fil-vina portali ġiet osservata b'cabozantinib, inkluż avveniment wieħed fatali.
English: Centralpharma Communications OÜ Ipsen Poland Sp. z o.o.
Maltese: Ipsen Poland Sp. z o.o. Al.
English: Events of venous thromboembolism, including pulmonary embolism, and arterial thromboembolism, sometimes fatal, have been observed with cabozantinib.
Maltese: Avvenimenti ta' tromboemboliżmu fil-vini, inkluż emboliżmu pulmonari, u tromboemboliżmu fl-arterji, xi drabi fatali, ġew osservati b'cabozantinib.
English: The safety and efficacy of CABOMETYX were evaluated in a randomized, double-blind, placebocontrolled Phase 3 study (CELESTIAL).
Maltese: Is-sigurtà u l-effikaċja ta' CABOMETYX kienu evalwati fi studju ta' Fażi 3 randomised, double-blind u kkontrollat bil-plaċebo (CELESTIAL).
English: CABOMETYX tablets are available in packs containing either 4 blisters with 7 tablets each (28 total), or one plastic bottle with 30 tablets.
Maltese: Pilloli CABOMETYX huma disponibbli f'pakketti li fihom 4 folji b'7 pilloli kull waħda (total ta' 28), jew flixkun wieħed tal-plastik bi 30 pillola.
English: • Alopecia (hair loss and thinning), hair colour change
Maltese: • Alopeċja (telf u traqqiq tax-xagħar), bidla fil-kulur tax-xagħar
English: Each film-coated tablet contains 46.61 mg lactose For the full list of excipients, see section 6.1.
Maltese: Kull pillola miksija b'rita fiha 46.61 mg lactose Għal-lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1.
English: A less than 10% difference in the AUC was observed between cabozantinib tablet (CABOMETYX) and capsule (COMETRIQ) formulations.
Maltese: Kienet osservata differenza ta' anqas minn 10% fl-AUC bejn il-formulazzjonijiet tal-pillola (CABOMETYX) u tal-kapsula (COMETRIQ) ta' cabozantinib.
English: The results from the Investigator determined analysis and IRC-determined analysis of PFS were consistent.
Maltese: Ir-riżultati mill-analiżi determinata mill-Investigatur u mill-analiżi determinata mill-IRC tal-PFS kienu konsistenti.
English: Based on an integrated population pharmacokinetic analysis of cabozantinib in healthy subjects and cancer patients (including HCC), no clinically significant difference in the mean cabozantinib plasma exposure was observed amongst subjects with normal liver function (n=1425) and mild hepatic impairment (n=558).
Maltese: Abbażi ta' analiżi integrata tal-farmakokinetika tal-popolazzjoni ta' cabozantinib f'individwi f'saħħithom u f'pazjenti bil-kanċer (inkluża HCC), ma ġietx osservata differenza klinikament sinifikanti fl-esponiment medju ta' cabozantinib fil-plażma fost individwi b'funzjoni normali tal-fwied (n=1425) u b'indeboliment ħafif tal-fwied (n=558).
English: According to the Memorial Sloan Kettering Cancer Center criteria for prognostic risk category, 46% were favorable (0 risk factors), 42% were intermediate (1 risk factor), and 13% were poor (2 or 3 risk factors).
Maltese: Skont il-kriterji taċ-Ċentru tal-Kanċer Memorial Sloan Kettering għall-kategorija ta' riskju pronjostiku, 46% kienu favorevoli (0 fatturi tar-riskju), 42% kienu intermedji (fattur ta' riskju 1), u 13% kienu baxxi (2 jew 3 fatturi ta' riskju).
English: Objective Response Rate n (%) by IRC Complete responses
Maltese: Rata ta' Rispons Oġġettiv n (%) minn IRC
English: Perforations and fistulas
Maltese: Perforazzjonijiet u fistuli