FrancophonIA/ELRC3.0 huggingface dataset:
English: Neutropenia is the most common adverse reaction of cabazitaxel (see section 4.8).
Maltese: In-newtropenija hija l-aktar reazzjoni avversa komuni ta' cabazitaxel (ara sezzjoni 4.8).
English: The incidence of grade ≥3 clinical neutropenia and febrile neutropenia adverse reactions were 21.3% and 7.5% respectively.
Maltese: Linċidenza tar-reazzjonijiet avversi ta' grad ≥ 3 tan-newtropenija klinika u n-newtropenija bid-deni kienu ta' 21.3 % u 7.5 % rispettivament.
English: Cardiac arrhythmias have been reported, most commonly tachycardia and atrial fibrillation (see section 4.8).
Maltese: Ġew irrapportati arritmiji kardijaċi, l-iżjed komuni it-takikardija u l-fibrillazzjoni atrijali (ara sezzjoni 4.8).
English: Common (may affect up to 1 in 10 people):
Maltese: Komuni (jistgħu jiġu affettwati sa persuna 1 minn kull 10):
English: JEVTANA is contraindicated in patients with severe hepatic impairment (see section 4.3).
Maltese: JEVTANA huwa kontraindikat f'pazjenti b'indeboliment epatiku sever (ara sezzjoni 4.3).
English: • You will usually have an infusion once every 3 weeks.
Maltese: • Normalment ikollok infużjoni darba kull 3 ġimgħat.
English: In the population pharmacokinetic analysis in 70 patients of 65 years and older (57 from 65 to 75 and 13 patients above 75), no age effect on the pharmacokinetics of cabazitaxel was observed.
Maltese: Fl-analiżi farmakokinetika tal-popolazzjoni f'70 pazjent li kellhom 65 sena u iżjed (57 minn 65 sa 75 u 13-il pazjent 'il fuq minn 75), ġie osservat li l-età ma kellha ebda effett fuq il-farmakokinetika ta' carbazitaxel.
English: Step 2.3
Maltese: Fażi 2.3
English: JEVTANA was evaluated in an open label, multi-center Phase 1/2 study conducted in a total of 39 paediatric patients (aged between 4 to18 years for the phase 1 part of the study and between 3 to 16 years for the phase 2 part of the study).
Maltese: JEVTANA ġie evalwat f'studju ta' Fażi 1/2, multiċentriku u open-label li sar f'total ta' 39 pazjent pedjatriku ( ta' etajiet bejn 4 sa 18-il sena għall-parti ta' Fażi 1 tal-istudju u ta' etajiet bejn 3 sa 16-il sena għall-parti ta' fażi 2 tal-istudju).
English: The most commonly (≥10%) occurring adverse reactions in all grades were anaemia (97.3%), leukopenia (95.7%), neutropenia (93.5%), thrombocytopenia (47.4%), and diarrhoea (46.6%).
Maltese: 7%), in-newtropenija (93.5%), it-tromboċitopenija (47.4%), u d-dijarrea (46.6%).
English: Upper respiratory tract infection Herpes zoster Candidiasis
Maltese: Herpes zoster Candidiasis
English: In the JEVTANA group, the mean age was 68 years, range (46-92) and the racial distribution was 83.9% Caucasian, 6.9% Asian/Oriental, 5.3% Black and 4% Others.
Maltese: u d-distribuzzjoni tar-razez kienet 83.9% Kawkażi, 6.9% Ażjatiċi/Orjentali, 5.3% Suwed u 4% Oħrajn.
English: Step 2.4
Maltese: Fażi 2.4
English: The most commonly (≥5%) occurring grade ≥3 adverse reactions in the cabazitaxel group were neutropenia (81.7%), leukopenia (68.2%), anaemia (10.5%), febrile neutropenia (7.5%), diarrhoea
Maltese: Laktar reazzjonijiet avversi komuni ((≥5%) ta' grad ≥ 3 li seħħew fil-grupp ta' cabazitaxel kienu nnewtropenija (81.7 %), il-lewkopinja (68.2%), l-anemija (10.5%), in-newtropenija bid-deni (7.5 %) u d-dijarrea (6.2 %).
English: The other ingredients are polysorbate 80 and citric acid in the concentrate, and ethanol 96% and water for injections in the solvent (see section 2 “JEVTANA contains alcohol”).
Maltese: Is-sustanzi l-oħra huma polysorbate 80 u aċidu ċitriku fil-konċentrat, u ethanol 96% u ilma għall injezzjonijiet fis-solvent (ara sezzjoni 2 “JEVTANA fih l-alkoħol”.
English: There was no statistically difference with regards to the other secondary endpoints (PFS, tumour and pain response, tumour and pain progression, and four subcategories of FACT-P).
Maltese: statistiku ma kien hemm ebda differenza fir-rigward tal-punti finali sekondarji l-oħra (PFS, rispons tattumur u tal-uġigħ, progressjoni tat-tumur u tal-uġigħ, u l-erba' sottokategoriji ta' FACT-P).
English: 1 vial of 1.5 ml concentrate and 1 vial of 4.5 ml solvent.
Maltese: Kunjett ta' 1.5 ml ta' konċentrat u kunjett ta' 4.5 ml ta' solvent
English: Muscle spasms Myalgia Musculoskeletal chest pain Flank pain
Maltese: Spażmi muskolari Majalġja Uġigħ muskolu skeletrali fis-sider
English: A dedicated study in 43 cancer patients with hepatic impairment showed no influence of mild (total bilirubin >1 to ≤1.5 x ULN or AST >1.5 x ULN) or moderate (total bilirubin >1.5 to ≤3.0 x ULN) hepatic impairment on cabazitaxel pharmacokinetics.
Maltese: Studju magħmul apposta f' 43 pazjent bil-kanċer u b'indeboliment epatiku, wera li indeboliment epatiku ħafif (total tal-bilirubin >1 sa ≤1.5 x ULN jew AST >1.5 x ULN) jew moderat (total tal-bilirubin >1.5 sa ≤3.0 x ULN) ma kellu ebda effett fuq il-farmakokinetika ta' cabazitaxel.
English: Cabazitaxel did not inhibit in vitro the major biotransformation pathway of warfarin into 7-hydroxywarfarin, which is mediated by CYP2C9.
Maltese: In vitro, cabazitaxel ma kkawżax l-inibizzjoni tal-mod l-aktar importanti li biha ssir il bijotrasformazzjoni ta' warfarin f'7-hydroxywarfarin, li ssir permezz ta' CYP2C9.
English: Frequencies are based on all grades and defined as: very common (≥1/10), common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Maltese: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1000 sa <1/100), rari (≥1/10,000 sa <1/1000), rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli) skont CTCAE 4.03.
English: In 3 patients with severe hepatic impairment (total bilirubin >3 ULN), a 39% decrease in clearance was observed when compared to patients with mild hepatic impairment, indicating some effect of severe hepatic impairment on cabazitaxel pharmacokinetics.
Maltese: F'3 pazjenti b'indeboliment epatiku sever (total tal-bilirubin >3 ULN), ġie osservat tnaqqis ta' 39% fit-tneħħija meta mqabbel ma' pazjenti b'indeboliment epatiku ħafif li jindika xi effett ta' indeboliment epatiku sever fuq il-farmakokinetika ta' cabazitaxel.
English: Number of deaths, n (%) Median survival (95% CI) (months)
Maltese: Sopravivenza Totali Numru ta' mwiet, n (%) Medjan ta' sopravivenza (95% CI) (xhur)
English: Step 2.2
Maltese: Fażi 2.2
English: 1 ml concentrate contains 40 mg cabazitaxel.
Maltese: Millilitru ta' konċentrat fih 40 mg cabazitaxel.
English: In addition, cabazitaxel demonstrated activity in tumour models insensitive to chemotherapy including docetaxel.
Maltese: Barra minn hekk, cabazitaxel wera attività f'mudelli ta' tumuri li mhumiex sensittivi għall-kemoterapija inkluża dik ta' docetaxel.
English: A sub-group of 59 patients received prior cumulative dose of docetaxel <225 mg/m² (29 patients in JEVTANA arm, 30 patients in mitoxantrone arm).
Maltese: Grupp żgħir ta' 59 pazjent irċevew minn qabel doża kumulattiva ta' docetaxel <225 mg/m² (29 pazjent fil-fergħa ta'JEVTANA , 30 pazjent fil-fergħa ta' mitoxantrone ).
English: There was an improvement in PFS in the JEVTANA arm compared to mitoxantrone arm, 2.8 (2.4-3.0) months versus 1.4 (1.4-1.7) respectively, HR (95%CI) 0.74 (0.64-0.86), p<0.0001.
Maltese: 2.8 (2.4-3.0) xahar kontra 1.4 (1.4-1.7) rispettivament, HR (95%CI) 0.74 (0.64-0.86), p<0.
English: In vitro, cabazitaxel has also been shown to inhibit the transport proteins of the Organic Anion Transport Polypeptides OATP1B1.
Maltese: Polipeptidi ta' Trasport tal-Anijoni Organiċi OATP1B1.
English: Each vial of 1.5 ml (nominal volume) of concentrate contains 60 mg cabazitaxel.
Maltese: Kull kunjett ta' 1.5 ml (volum nominali) ta' konċentrat fih 60 mg ta' cabazitaxel.
English: • decrease in the number of platelets (which results in increased risk of bleeding)
Maltese: • tnaqqis fin-numru ta' plejtlits (li jirriżulta f'żieda fir-riskju ta' fsada)
English: Cabazitaxel inhibited the transport of P-glycoprotein (PgP) (digoxin, vinblastin), Breast-Cancer-Resistant-Proteins (BCRP) (methotrexate) and Organic Anion Transporting Polypeptide OATP1B3 (CCK8) at concentrations at least 15 fold what is observed in clinical setting while it inhibited the transport of OATP1B1 (estradiol-17β-glucuronide) at concentrations only 5 fold what is observed in clinical setting.
Maltese: Cabazitaxel kkawża l-inibizzjoni tat-trasport tal-P-glycoprotein (PgP) (digoxin, vinblastin), tal-Breast-Cancer-Resistant-Proteins (BCRP) (methotrexate) u t-Trasportatur Polipeptide tal-Anijoni Organiċi OATP1B3 (CCK8),
English: • Hypersensitivity to cabazitaxel, to other taxanes, or polysorbate 80 or any excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għal carbazitaxel, għal taxanes oħra, jew polysorbate 80 jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: Cabazitaxel is minimally excreted via the kidney (2.3% of the dose).
Maltese: Ftit minn cabazitaxel jiġi mneħħi permezz tal-kliewi (2.3% tad-doża).
English: Concentrate-solvent mixture 10 mg/ml
Maltese: Taħlita konċentrat solvent10 mg/ml
English: Haematuria all grades frequency was 20.8% at 25 mg/m2 in EFC11785 study (see section 5.1).
Maltese: Fl-istudju EFC11785, il-frekwenza ta' ematurja fil-gradi kollha kienet ta' 20.8% b'25 mg/m2 (ara sezzjoni 5.1).
English: All Grade events among cardiac disorders were more common on cabazitaxel of which 6 patients (1.6%) had Grade ≥3 cardiac arrhythmias.
Maltese: Avvenimenti ta' kull grad fost id-disturbi tal-qalb kienu aktar komuni għal cabazitaxel li minnhom 6 pazjenti (1.6 %) kellhom arritmiji kardijaċi ta' Grad ≥ 3.
English: For instructions on preparation and administration of the product, see section 6.6.
Maltese: Għal istruzzjonijiet fuq il-preparazzjoni u l-amministrazzjoni tal-prodott, ara sezzjoni 6.6.
English: The incidence of the following grade ≥3 adverse reactions were higher in patients 65 years of age compared to younger patients; neutropenia based on laboratory abnormalities (86.3% versus 73.3%), clinical neutropenia (23.8% versus 16.8%) and febrile neutropenia (8.3% versus 6.1%) (see sections 4.2 and 4.4).
Maltese: laboratorju (86.3% kontra 73.3%), in-newtropenija klinika (23.8% kontra 16.8%) u n-newtropenija bid-deni (8.3% kontra 6.1%) (ara sezzjonijiet 4.2 and 4.4).
English: Repeated administration of ketoconazole (400 mg once daily), a strong CYP3A inhibitor, resulted in a 20% decrease in cabazitaxel clearance corresponding to a 25% increase in AUC.
Maltese: Għoti ripetut ta' ketoconazole (400 mg darba kuljum), inibitur qawwi ta' CYP3A, wassal għal tnaqqis ta' 20% fit-tneħħija ta' cabazitaxel li jikkorispondi għal żieda ta' 25% fl-AUC.
English: Step 1.4
Maltese: Fażi 1.4
English: Step 1.3
Maltese: Fażi 1.3
English: Risk of renal failure
Maltese: Riskju ta' insuffiċjenza renali
English: Treatment with JEVTANA is contraindicated in patients with severe hepatic impairment (total bilirubin > 3 x ULN) (See sections 4.3 and 5.2).
Maltese: Il-kura b'JEVTANA huwa kontraindikat f'pazjenti b'indeboliment epatiku sever (total tal-bilirubin > 3 x ULN) (Ara sezzjonijiet 4.3 u 5.2).
English: Peripheral oedema Mucosal inflammation Pain
Maltese: Inkontinenza awrinarja Ostruzzjoni flureteru
English: Your doctor may need to treat you.
Maltese: Ir-riskju ta' interazzjoni ma' sustrati ta'
English: The following adverse reactions reported at rates 5% higher in patients 65 years of age or greater compared to younger patients were fatigue (40.4% versus 29.8%), clinical neutropenia (24.2% versus 17.6%), asthenia (23.8% versus 14.5%), pyrexia (14.6% versus 7.6%), dizziness (10.0% versus 4.6%), urinary tract infection (9.6% versus 3.1%) and dehydration (6.7% versus 1.5%), respectively.
Maltese: 5%), id-deni (14.6% kontra 7.6%), l-isturdament (10.0% kontra 4.6%), l-infezzjoni tal-passaġġ urinarju(9.6% kontra 3.1%) u d-deidrazzjoni (6.7% kontra 1.5%), rispettivament.
English: Cardiac failure events were more common on cabazitaxel, the event term being reported for 2 patients (0.5%).
Maltese: Avvenimenti ta' insuffiċjenza kardijaka kienu aktar komuni għal dawk fuq cabazitaxel, b'dan l-avveniment irrapportat f'2 pazjenti (0.5%).
English: Inject the entire contents into the corresponding concentrate vial.
Maltese: Injetta l-kontenut kollu fil-kunjett tal konċentrat.
English: Grade ≥ 3 thrombocytopenia
Maltese: KLINIKU 4.1 Indikazzjonijiet terapewtiċi
English: Note: Both the JEVTANA 60 mg/1.5 ml concentrate vial (fill volume: 73.2 mg of cabazitaxel/1.83 ml) and the solvent vial (fill volume: 5.67 ml) contain an overfill to compensate for liquid loss during preparation.
Maltese: Nota: Kemm il-kunjett ikkonċentrat ta' JEVTANA 60 mg/1.5 ml (volum ta' mili: 73.2 mg ta' cabazitaxel/1.83 ml) kif ukoll il-kunjett tas-solvent (volum ta' mili: 5.67 ml) huma mimlijin ftit żejjed biex jagħmlu tajjeb għal telf ta' likwidu waqt il-preparazzjoni.
English: Overall survival was significant longer with JEVTANA compared to mitoxantrone (15.1 months versus 12.7 respectively), with a 30% reduction in the risk of death compared to mitoxantrone (see table 3 and figure 1).
Maltese: Fil-grupp ta' JEVTANA, is-sopravivenza totali kienet itwal b'mod sinifikanti meta mqabbla ma' mitoxantrone (15.1 xahar kontra 12.7 xahar rispettivament), b'tnaqqis ta' 30 % fir-riskju ta' mewt meta mqabbel ma' mitoxantrone (ara tabella 3 u figura 1).
English: There is no relevant use of JEVTANA in the paediatric population.
Maltese: M'hemm ebda użu rilevanti għal JEVTANA fil-popolazzjoni pedjatrika.
English: Sanofi S.p.A Tel: +39 02 39394275
Maltese: Tel: +39. 02 39394275
English: NAME OF THE MEDICINAL PRODUCT JEVTANA 60 mg concentrate and solvent for solution for infusion cabazitaxel
Maltese: TAL-PRODOTT MEDIĊINALI JEVTANA 60 mg konċentrat u solvent għal soluzzjoni għall-infużjoni cabazitaxel
English: Step 1.1
Maltese: Fażi 1.1
English: Vertigo
Maltese: Tinnitus Vertigo
English: Renal colic Haematuria Pollakiuria Hydronephrosis Urinary retention Urinary incontinence Ureteric obstruction
Maltese: Il-professjonisti dwar il-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
English: JEVTANA in combination with prednisone or prednisolone is indicated for the treatment of adult patients with metastatic castration resistant prostate cancer previously treated with a docetaxel-containing regimen (see section 5.1).
Maltese: JEVTANA flimkien ma' prednisone jew prednisolone huwa indikat fil-kura ta' pazjenti adulti b'kanċer metastatiku tal-prostata reżistenti għall-kastrazzjoni u li preċedentement ġew ikkurati b'skeda ta' dożaġġ li kellu fih docetaxel (ara sezzjoni 5.1).
English: Therefore concomitant administration of strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) should be avoided as an increase of plasma concentrations of cabazitaxel may occur (see sections 4.2 and 4.4).
Maltese: indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) għandu jiġi evitat minħabba li jistgħu jseħħu żidiet fil-konċentrazzjonijiet ta' cabazitaxel fil-plażma (ara sezzjonijiet 4.2 u 4.4).
English: After 1-hour intravenous administration at 25 mg/m2 cabazitaxel in patients with metastatic prostate cancer (n=67), the Cmax was 226 ng/ml (Coefficient of Variation (CV): 107%) and was reached at the end of the 1-hour infusion (Tmax).
Maltese: Siegħa wara l-għoti minn ġol-vini ta' cabazitaxel b'doża ta' 25 mg/m2 f'pazjenti b'kanċer metastatiku tal-prostata (n=67), is-Cmax kien ta' 226 ng/ml (Ko-effiċjent ta' Varjazzjoni (CV): 107%) u ntlaħaq fl aħħar tas-siegħa ta' infużjoni (Tmax).
English: In vitro studies have shown that cabazitaxel is mainly metabolised through CYP3A (80% to 90%) (see section 5.2).
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Studji in vitro wrew li cabazitaxel jiġi mmetabolizzat primarjament minn CYP3A (80% sa 90%) (ara sezzjoni 5.2).
English: Of the 595 patients treated with cabazitaxel 25 mg/m2 in the prostate cancer EFC 11785 study, 420 patients were 65 years or over.
Maltese: Mill-595 pazjent ikkurati b'cabazitaxel 25 mg/m2 fl-istudju EFC 11785 dwar il-kanċer tal-prostata, 420 pazjent kellhom 65 sena jew iżjed.
English: There was a median PSA progression of 6.4 months (95%CI: 5.1-7.3) for patients in JEVTANA arm, compared to 3.1 months (95%CI: 2.2-4.4) in the mitoxantrone arm, HR 0.75 months (95%CI: 0.63-0.90), p=0.0010.
Maltese: Il-medjan tal-progressjoni tal-PSA kien ta' 6.4 xahar (95%CI: 5.1-7.3) għall-pazjenti fil-fergħa ta' JEVTANA , meta mqabbel ma' 3.1 xahar (95%CI: 2.2-4.4) fil-fergħa ta' mitoxantrone , HR 0.75 xahar (95%CI 0.63-0.90), p=0.0010.
English: Cabazitaxel is mainly excreted in the faeces as numerous metabolites (76% of the dose); while renal excretion of cabazitaxel and metabolites account for less than 4% of the dose (2.3% as unchanged medicinal product in urine).
Maltese: Cabazitaxel jiġi mneħħi l-iżjed filpurgar bħala numru kbir ta' metaboliti (76% tad-doża); waqt li t-tneħħija renali ta' cabazitaxel u lmetaboliti tirrappreżenta inqas minn 4 % tad-doża (2.3% bħala prodott mediċinali li ma nbidilx fl awrina).
English: All grade adverse reactionsa (%) Diarrhoea
Maltese: Reazzjonijiet avversi ta' kull grada (%) Dijarea
English: The dose of cabazitaxel should be reduced from 25 mg/m2 to 20 mg/m2 for persistent grade >2 peripheral neuropathy (see section 4.2).
Maltese: Id-doża ta' cabazitaxel għandha titnaqqas minn 25 mg/m2 sa 20 mg/m2 għal newropatija periferali ta' grad >2 li qiegħda ddum fiż-żmien (ara sezzjoni 4.2).
English: Chemical and physical stability of the infusion solution has been demonstrated for 8 hours at ambient temperature (15°C - 30°C) including the 1-hour infusion time and for 48 hours at refrigerated conditions including the 1-hour infusion time.
Maltese: L-istabbilità kimika u fiżika tas-soluzzjoni tal-infużjoni ġiet dimostrata għal 8 sigħat f'temperatura ambjentali (15°C - 30°C) inkluża s-siegħa tal-infużjoni u għal 48 siegħa f'kundizzjonijiet mkessħa inkluża s-siegħa tal-infużjoni.
English: Cabazitaxel should not be given to patients with severe hepatic impairment (total bilirubin >3 x ULN) (see sections 4.3, 4.4 and 5.2).
Maltese: Cabazitaxel m'għandux jingħata lill-pazjenti b'indeboliment epatiku sever (total ta' bilirubin >3 x ULN) (ara sezzjonijiet 4.3, 4.4 u 5.2).
English: Therefore concomitant administration of strong CYP3A inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital) should be avoided as a decrease of plasma concentrations of cabazitaxel may occur (see sections 4.2 and 4.4).
Maltese: rifampin, rifabutin, rifapentin, phenobarbital) għandu jiġi evitat minħabba li jista' jseħħ tnaqqis fil konċentrazzjonijiet ta' cabazitaxel fil-plażma (ara sezzjonijiet 4.2 u 4.4).
English: In a non-inferiority, multicenter, multinational, randomized, open label phase III study (EFC11785 study), 1200 patients with metastatic castration resistant prostate cancer, previously treated with a docetaxel-containing regimen, were randomized to receive either cabazitaxel 25 mg/m2 (n=602) or 20 mg/m2 (n=598) dose.
Maltese: III open-label, magħmul b'mod arbitrarju, multinazzjonali, multiċentriku u magħmul biex juri li m'hemmx inferjorità (l-istudju EFC11785 ), 1200 pazjent b'kanċer metastatiku tal-prostata reżistenti għall-kastrazzjoni, li preċedentement ġew ikkurati b'skeda li kien fiha docetaxel, b'mod arbitrarju ġew magħżula biex jirċievu doża ta' cabazitaxel ta' jew 25 mg/m2 (n=602) jew 20 mg/m2
English: Cabazitaxel is active in docetaxel-sensitive tumours.
Maltese: Cabazitaxel huwa attiv f'tumuri li huma sensittivi għal docetaxel.
English: This fill volume has been established during the development and the overfill ensures, after the addition of the entire content of the solvent vial to the content of JEVTANA 60 mg concentrate vial, a concentration of the premix solution of 10 mg/ml JEVTANA.
Maltese: Perjodu ta' ħażna u prekawzjonijiet speċjali tal-ħażna Għall-pakkett ta' JEVTANA 60 mg konċentrat u solvent Taħżinx 'l fuq minn 30°C.
English: Table 5 - Summary of safety data for cabazitaxel 25 mg/m2 arm versus cabazitaxel 20 mg/m2 arm in EFC11785 study
Maltese: Tabella 5 - Sommarju tat-tagħrif ta' sigurtà għall-fergħa ta' cabazitaxel 25 mg/m kontra l fergħa ta' cabazitaxel 20 mg/m2 fl-istudju EFC11785
English: Cases of peripheral neuropathy, peripheral sensory neuropathy (e.g., paraesthesias, dysaesthesias) and peripheral motor neuropathy have been observed in patients receiving cabazitaxel.
Maltese: F'pazjenti li qed jirċievu cabazitaxel ġew osservati każijiet ta' newropatija periferali, newropatija sensorja periferika (eż. parasteżija,disesteżija) u newropatija periferali tal-movimenti.
English: If co-administration with a strong CYP3A inhibitor cannot be avoided, close monitoring for toxicity and a cabazitaxel dose reduction should be considered (see sections 4.2 and 4.5).
Maltese: Jekk l-għoti flimkien ma' inibitur qawwi ta' CYP3A ma jistax jiġi evitat, għandu jitqies monitoraġġ mill-qrib għal tossiċità u tnaqqis fid-doża ta' cabazitaxel (ara sezzjonijiet 4.2 u 4.5).
English: • muscle spasm
Maltese: • embolu fis-sieq
English: Seven metabolites were detected in plasma (including 3 active metabolites issued form O-demethylations), with the main one accounting for 5% of parent exposure.
Maltese: metaboliti (li jinkludu 3 metaboliti attivi li saru mill-O-demetilazzjonijiet), bl-aktar wieħed importanti jirrappreżenta 5% espożizzjoni oriġinali.
English: • Concomitant vaccination with yellow fever vaccine (see section 4.5).
Maltese: • It-teħid fl-istess ħin tat-tilqima kontra l-yellow fever (ara sezzjoni 4.5).
English: A total of 755 patients were randomised to receive either JEVTANA 25 mg/m2 intravenously every 3 weeks for a maximum of 10 cycles with prednisone or prednisolone 10 mg orally daily (n=378), or to receive mitoxantrone 12 mg/m2 intravenously every 3 weeks for a maximum of 10 cycles with prednisone or prednisolone 10 mg orally daily (n=377).
Maltese: B'mod arbitrarju, total ta' 755 pazjent ġew magħżula biex jirċievu jew JEVTANA 25 mg/m2 mogħti minn ġol-vini kull 3 ġimgħat għal massimu ta' 10 ċikli flimkien ma' prednisone jew prednisolone 10 mg meħud b'mod orali kuljum (n=378), jew biex jirċievu mitoxantrone 12 mg/m2 mogħti minn ġolvini kull 3 ġimgħat għal massimu ta' 10 ċikli flimkien ma' prednisone jew prednisolone 10 mg meħud b'mod orali kuljum (n=377).
English: p-value 1HR estimated using Cox model; a hazard ratio of less than 1 favours JEVTANA
Maltese: 1HR stmat bl-użu tal-mudell Cox; proporzjon ta' riskju inqas minn 1 jiffavorixxi JEVTANA
English: Cabazitaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells.
Maltese: Cabazitaxel huwa sustanza antineoplastika li jaħdem billi jħarbat l-istrutturi mikrotubulari ġoċ-ċelluli.
English: • you are allergic (hypersensitive) to cabazitaxel, to other taxanes, or polysorbate 80 or any of the other excipients of this medicine (listed in section 6),
Maltese: • inti allerġiku/a (tbati minn sensittività eċċessiva) għal cabazitaxel, għal taxanes oħra, jew polysorbate 80 jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis-sezzjoni 6),
English: There was no statistical difference between both treatment arms in pain progression and pain response.
Maltese: Statistikament ma kien hemm ebda differenza fiż-żewġ fergħat ta' kura fil-progressjoni tal-uġigħ u fir rispons tal-uġigħ.
English: All grades n (%)
Maltese: Il-Gradi kollha n (%)
English: Gastroesophageal reflux disease
Maltese: Mard ta' Rifluss Gastroesofagali
English: Delay treatment until neutrophil count is >1,500 cells/mm3, then reduce cabazitaxel dose from 25 mg/m2 to 20 mg/m2.
Maltese: Ipposponi l-kura sakemm tara titjib jew ir reazzjoni tkun għaddiet, u sakemm l-għadd tan newtrofili huwa >1,500 ċelluli/mm3, imbagħad naqqas id-doża ta' cabazitaxel minn 25 mg/m2 għal 20 mg/m2.
English: Its common name is cabazitaxel.
Maltese: L-isem komuni tiegħu huwa cabazitaxel.
English: After initial dilution of the concentrate with the solvent Chemical and physical in-use stability has been demonstrated for 1 hour at ambient temperature (15°C-30°C).
Maltese: Ġie muri li l-istabbiltà kimika u fiżika waqt l-użu hija ta' siegħa f'temperatura ambjentali (15°C30°C).