FrancophonIA/ELRC3.0 huggingface dataset:
English: • JEVTANA will be given to you by a doctor or a nurse.
Maltese: • JEVTANA jingħatalek minn tabib jew infermier.
English: Adverse reactions not observed in clinical studies, but seen in dogs after single dose, 5-day and weekly administation at exposure levels lower than clinical exposure levels and with possible relevance to clinical use were arteriolar/periarterolar necrosis in the liver, bile ductule hyperplasia and/or hepatocellular necrosis (see section 4.2).
Maltese: Reazzjonijiet avversi li ma ġewx osservati f'studji kliniċi iżda li dehru f'klieb wara t-teħid ta' doża waħda, ħamest ijiem ta' teħid u teħid ta' darba fil-ġimgħa f'livelli ta' espożizzjoni inqas minn dawk kliniċi u li jistgħu jkunu ta' rilevanza f'użu kliniku kienu nekrożi arterjolari/periarterjolari fil-fwied, iperplażja tal-kanali biljari u/jew nekrożi epatoċellulari (ara sezzjoni 4.2).
English: Premedication The recommended premedication regimen should be performed at least 30 minutes prior to each administration of JEVTANA with the following intravenous medicinal products to mitigate the risk and severity of hypersensitivity:
Maltese: L-iskeda rrakkomandata ta' premedikazzjoni għandha ssir għallinqas 30 minuta qabel kull amministrazzjoni ta' JEVTANA permezz ta' injezzjoni minn ġol-vini b'dawn il-prodotti mediċinali li ġejjin sabiex titnaqqas ir-riskju u s-severità ta' sensittività eċċessiva:
English: Clinical neutropenia
Maltese: Disturbi psikjatriċi
English: After final dilution in the infusion bag/bottle
Maltese: Wara d-dilwizzjoni finali fil-borża/flixkun tal-infużjoni
English: Solvent vial
Maltese: Kunjett tas-solvent
English: Table 3 - Efficacy of JEVTANA in EFC6193 study in the treatment of patients with metastatic castration resistant prostate cancer
Maltese: Tabella 3 - L-Effikaċja ta' JEVTANA fl-istudju EFC6193 fil-kura ta' pazjenti b'kanċer metastatiku tal-prostata reżistenti għall-kastrazzjoni JEVTANA + prednisone n=378
English: Step 2: Second (final) dilution for infusion
Maltese: Fażi 2: It-tieni (l-aħħar) dilwizzjoni għall-infużjoni Fażi 2.1
English: A statistically significantly higher percentage (p<0.001) of patients showed a PSA response in the 25 mg/m2 group (42.9%) compared to the 20 mg/m2 group (29.5%).
Maltese: 001) ta' pazjenti wrew rispons fil-PSA fil-grupp tal-25 mg/m2 (42.9%) meta mqabbel mal-grupp tal-20 mg/m2
English: Elderly people (≥65 years of age) may be more likely to experience certain adverse reactions including neutropenia and febrile neutropenia (see section 4.8).
Maltese: Nies anzjani (≥ 65 sena) għandhom aktar riskju li jbatu minn xi reazzjonijiet avversi inkluż in newtropenija u n-newtropenija bid-deni (ara sezzjoni 4.8).
English: There was a significant higher rate of tumour response of 14.4% (95%CI: 9.6-19.3) in patients in the JEVTANA arm compared to 4.4% (95%CI: 1.6-7.2) for patients in the mitoxantrone arm, p=0.0005.
Maltese: Kien hemm rata sinifikament ogħla ta' 14.4% (95%CI: 9.6-19.3) fir-rispons tat-tumur fil-pazjenti filfergħa ta' JEVTANA meta mqabbel mal-4.4% (95%CI: 1.6-7.2) għall-pazjenti fil-fergħa ta'
English: After initial dilution of JEVTANA 60 mg concentrate with the entire contents of the solvent vial chemical and physical in-use stability has been demonstrated for 1 hour at ambient temperature.
Maltese: Wara d-dilwizzjoni inizjali tal-konċentrat ta' JEVTANA 60 mg bil-kontenut KOLLU tal-kunjett tas solvent, l-istabbilità kimika u fiżika waqt l-użu ġiet dimostrata għal siegħa f'temperatura ambjentali.
English: Caution is advised with treatment of patients most at risk of developing gastrointestinal complications: those with neutropenia, the elderly, concomitant use of NSAIDs, anti-platelet therapy or anti-coagulants, and patients with a prior history of pelvic radiotherapy or gastrointestinal disease, such as ulceration and GI bleeding.
Maltese: Hija rrakkomandata l-kwatela fil-kura ta' pazjenti li huma l-aktar fir-riskju li jiżviluppaw kumplikazzjonijiet gastrointestinali: dawk b'newtropenija, l-anzjani, l-użu fl-istess ħin ta' NSAIDs, terapija ta' kontra l-plejtlits jew anti koagulanti u pazjenti b'passat mediku ta' radjuterapija fiż-żona tal-pelvis jew mard gastrointestinali bħal ulċerazzjoni u fsada gastrointestinali.
English: Delay treatment until improvement, then reduce cabazitaxel dose from 25 mg/m2 to 20 mg/m2.
Maltese: Ipposponi l-kura sakemm tara titjib jew ir reazzjoni tkun għaddiet, imbagħad naqqas id-doża ta' cabazitaxel minn 25 mg/m2 għal 20 mg/m2.
English: Haematuria
Maltese: Tilqim
English: Symptoms such as abdominal pain and tenderness, fever, persistent constipation, diarrhoea, with or without neutropenia, may be early manifestations of serious gastrointestinal toxicity and should be evaluated and treated promptly.
Maltese: Sintomi bħal uġigħ addominali u sensittività, deni, stitikezza persistenti, dijarea, b'newtropenija jew mingħajr, jistgħu jkunu manifestazzjonijiet bikrija ta' tossiċità serja gastrointestinali u għandhom jiġu evalwati u kkurati mingħajr dewmien.
English: Psychiatric disorders Anxiety Confusional state Nervous system Dysgeusia
Maltese: Disturbi fis-sistema nervuża
English: Each vial of concentrate contains 60 mg cabazitaxel.
Maltese: Kull kunjett ta' konċentrat fih 60 mg cabazitaxel.
English: Bone marrow suppression manifested as neutropenia, anaemia, thrombocytopenia, or pancytopenia may occur (see “Risk of neutropenia” and “Anaemia” in section 4.4 below).
Maltese: Ġew irrapportati każijiet ta' pnewmonja interstizjali/pulmonite u mard interstizjali tal-pulmun, xi kultant fatali, b'frekwenza mhux magħrufa (ma tistax tittieħed stima mid-dejta disponibbli) (ara sezzjoni 4.4).
English: Number of patients with deaths (%) Median survival (months) (95% CI) Hazard Ratio (HR)1 (95% CI)
Maltese: Sopravivenza totali Numru ta' pazjenti li mietu (%) Il-medjan ta' sopravivenza (xhur) (95% CI)
English: Clinical neutropenia Urinary tract infection Peripheral sensory neuropathy
Maltese: Newtropenija klinika Infezzjoni fil-passaġġ urinarju
English: cabazitaxel once every three weeks in a randomised open label, controlled phase III study.
Maltese: III tat-tip randomized u open-label.
English: • you have ever had any allergies.
Maltese: • qatt kellek xi allerġija.
English: Adverse reactions not observed in clinical studies, but seen in rats during repeat-dose toxicity studies at exposure levels higher than clinical exposure levels and with possible relevance to clinical use were eye disorders characterized by subcapsular lens fiber swelling/degeneration.
Maltese: Reazzjonijiet avversi li ma ġewx osservati f'studji kliniċi iżda li dehru fil-firien waqt studji ta' tossiċità b'dożi ripetuti f'livelli ta' espożizzjoni ogħla minn dawk kliniċi u li jistgħu jkunu ta' rilevanza f'użu kliniku kienu disturbi fl-għajnejn ikkaratterizzati b'deġenerazzjoni/nefħa tal-fibra subkapsulari tal-lenti.
English: Hyperglycaemia
Maltese: • demm fl-awrina
English: Tinnitus
Maltese: Anzjani
English: Package leaflet: Information for the patient JEVTANA 60 mg concentrate and solvent for solution for infusion cabazitaxel
Maltese: Informazzjoni għall-pazjent JEVTANA 60 mg konċentrat u solvent għal soluzzjoni għall-infużjoni cabazitaxel
English: Confounding causes such as disease progression, instrumentation, infection or anticoagulation/NSAID/aspirin therapy were identified in nearly two thirds of the cases.
Maltese: Fatturi ta' fixkla bħall-progressjoni tal-marda, l-instrumentazzjoni, infezzjoni jew terapija ta' antikoagulazzjoni/NSAID/aspirina gew identifikati f'madwar żewġ terzi tal-każijiet.
English: Cabazitaxel is eliminated primarily via liver metabolism.
Maltese: Cabazitaxel jiġi eliminat primarjament permezz ta' metaboliżmu fil-fwied.
English: Number of patients with dose reduction n (%)
Maltese: Numru ta' pazjenti b'tnaqqis fid-doża n (%)
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83 EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti għas-sottomissjoni tar- rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq ilportal elettroniku Ewropew tal-mediċini.
English: Anaemia a
Maltese: ANNESS III
English: Neuropathy peripheral Peripheral sensory neuropathy Dizziness Headache Paraesthesia Lethargy
Maltese: Newropatija sensorjali periferali
English: • Solvent: 4.5 ml of solvent in a 15 ml clear glass vial (type I) closed with a grey chlorobutyl rubber closure sealed by a gold colour aluminium cap covered with a colourless plastic flip-off cap. Each vial contains 4.5 ml nominal volume (fill volume: 5.67 ml).
Maltese: • Solvent: 4.5 ml ta' solvent f'kunjett ċar tal-ħġieġ (tat-tip 1) ta' 15 ml magħluq b'tapp griż magħmul mill-gomma tal-chlorobutyl issiġillat b'għatu tal-aluminju kulur tad-deheb mgħotti b'għatu tal-plastik bla kulur tat-tip ‘flip-off'.
English: Chest pain Oedema
Maltese: KAXXA TA' BARRA
English: Vomiting
Maltese: Pulmonite
English: Delay treatment until improvement or resolution, then reduce cabazitaxel dose from 25 mg/m2 to
Maltese: Ipposponi l-kura sakemm tara titjib, imbagħad naqqas id-doża ta' cabazitaxel minn 25 mg/m2
English: METHOD AND ROUTE(S) OF ADMINISTRATION Single-use vials.
Maltese: skont l-Eastern Cooperative Oncology Group (ECOG) .
English: 1.5 ml 10 mg/ml after first dilution.
Maltese: 1.5 ml 10 mg/ml wara l-ewwel dilwizzjoni
English: Primary prophylaxis with G-CSF should be considered in patients with high-risk clinical features (age >65 years, poor performance status, previous episodes of febrile neutropenia, extensive prior radiation ports, poor nutritional status, or other serious comorbidities) that predispose them to increased complications from prolonged neutropenia.
Maltese: Profilassi primarja b'G-CSF għandu jiġi kkunsidrat f'pazjenti b'karatteristiċi kliniċi li huma ta' riskju għoli (età > 65 sena, stat ġenerali ħażin, episodji preċedenti ta' newtropenija bid-deni, radjazzjoni preċedenti f'postijiet estensivi, stat ta' nutrizzjoni fqira jew mard ieħor serju fl-istess ħin) u li jagħmluhom suġġetti għal żieda fil-kumplikazzjonijiet min-newtropenija fit-tul.Ġie muri li G-CSF inaqqas l-inċidenza u s-severità tan-newtropenija.
English: Ear and labyrinth disorders
Maltese: Anoressija Deidrazzjoni
English: Influenza Cystitis
Maltese: Influwenza Ċistite
English: Grade >2 peripheral neuropathy
Maltese: Newropatija periferali ta' grad ≥2
English: Concomitant medicinal products use
Maltese: TAL-PRODOTT MEDIĊINALI
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Maltese: Għall-kundizzjonijiet ta' ħażna wara li ssir id-dilwizzjoni tal-prodott mediċinali, ara sezzjoni 6.3. 6.5
English: • urinary tract infection
Maltese: • infezzjoni fil-passaġġ urinarju
English: • chills.
Maltese: • morliti
English: Around 20 metabolites of cabazitaxel are excreted into human urine and faeces.
Maltese: Madwar 20 metabolit ta' cabazitaxel jiġu mneħħija fl-awrina u fil-purgar uman.
English: • Concentrate: 1.5 ml of concentrate in a 15 ml clear glass vial (type I) closed with a grey chlorobutyl rubber closure sealed by an aluminium cap covered with a light green plastic flip-off cap. Each vial contains 60 mg cabazitaxel per 1.5 ml nominal volume (fill volume: 73.2 mg of cabazitaxel/1.83 ml).
Maltese: Kull kunjett fih 60 mg ta' cabazitaxel għal kull 1.5 ml ta' volum nominali (volum ta' mili: 73.2 mg ta' cabazitaxel/ 1.83 ml).
English: Renal disorders, have been reported in association with sepsis, severe dehydration due to diarrhoea, vomiting and obstructive uropathy.
Maltese: Ġew irrapportati disturbi renali flimkien ma' sepsis, deidrazzjoni severa minħabba d-dijarea, rimettar u uropatija ta' imblukkar.
English: Patients with mild hepatic impairment (total bilirubin >1 to ≤1.5 x Upper Limit of Normal (ULN) or AST >1.5 x ULN), should have cabazitaxel dose reduced to 20 mg/m2.
Maltese: Pazjenti b'indeboliment epatiku ħafif (total tal-bilirubin >1 sa ≤1.5 x Il-Limitu Massimu tan-Normal (ULN-upper limit of normal) jew AST
English: Exposures in animals were similar or lower than those seen in humans receiving clinically relevant doses of cabazitaxel.
Maltese: L-esponiment fl annimali kien simili jew inqas minn dak li jkun hemm fl-umani li qed jirċievu dożi klinikament rilevanti ta' cabazitaxel.
English: What JEVTANA looks like and contents of the pack JEVTANA is a concentrate and solvent for solution for infusion (sterile concentrate).
Maltese: JEVTANA huwa konċentrat u solvent għal soluzzjoni għall-infużjoni (konċentrat sterili).
English: The use of G-CSF has been shown to limit the incidence and severity of neutropenia (see sections 4.2 and 4.4).
Maltese: Ġie muri li l-użu ta' G-CSF inaqqas l-inċidenza u s-severità tan-newtropenija (ara sezzjonijiet 4.2 u
English: Dose should be reduced for patients with mild (total bilirubin >1 to ≤1.5 x ULN or AST >1.5 x ULN), hepatic impairment (see sections 4.2 and 5.2).
Maltese: Id-doża għandha titnaqqas għall-pazjenti b'indeboliment epatiku ħafif (total tal-bilirubin >1 sa ≤1.5 x ULN jew AST >1.5 x ULN) (ara sezzjonijiet 4.2 u 5.2).
English: However, if patients require co-administration of a strong CYP3A inhibitor, a 25% cabazitaxel dose reduction should be considered (see sections 4.4 and 4.5).
Maltese: Madankollu, jekk il-pazjenti jeħtieġu għoti flimkien ma' inibitur qawwi ta' CYP3A, għandu jitqies tnaqqis ta' 25% fid-doża ta' cabazitaxel (ara sezzjonijiet 4.4 u 4.5).
English: Haemorrhoids
Maltese: Kunjett tassolvent
English: Dyspnoea Cough
Maltese: Reazzjoni Avvers
English: Inject in a sterile PVC-free container of either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Maltese: Injetta ġo kontenitur sterili ħieles mill-PVC u li fih jew soluzzjoni għall-infużjoni ta' 5%
English: The efficacy and safety of JEVTANA in combination with prednisone or prednisolone were evaluated in a randomised, open-label, international, multi-center, phase III study (EFC6193 study), in patients with metastatic castration resistant prostate cancer previsouly treated with a docetaxel containing regimen.
Maltese: III (l-istudju EFC6193), b'ħafna siti, internazzjonali, randomized u open-label, f'pazjenti b'kanċer metastatiku tal-prostata reżistenti għall-kastrazzjoni li preċedentement ġew ikkurati b'skeda li kien fiha docetaxel.
English: Septic shock Sepsis Cellulitis Urinary tract infection
Maltese: Konċentrat u solvent għal soluzzjoni għall-infużjoni (konċentrat sterilizzat)
English: It was not clastogenic in an in vitro test in human lymphocytes (no induction of structural chromosomal aberration but it increased number of polyploid cells) and induced an increase of micronuclei in the in vivo test in rats.
Maltese: Ma kienx klastoġeniku f'test in vitro f'limfoċiti umani ( ma kkawżawx devjazzjoni mis-struttura normali talkromosomi iżda żied in-numru ta' ċelluli poliplojdi) u fit-test in vivo fil-firien ikkawża żieda fil mikronuklei.
English: Neutropenic complications included neutropenic infections (0.5%), neutropenic sepsis (0.8%), and septic shock (1.1%), which in some cases resulted in a fatal outcome.
Maltese: Il-kumplikazzjonijiet tan-newtropenija kienu jinkludu infezzjonijiet newtropeniċi (0.5 %), sepsis newtropenika (0.8 %) u xokk settiku (1.1 %), li f'xi każijiet irriżultaw fil-mewt tal-pazjent.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION JEVTANA 60 mg sterile concentrate cabazitaxel
Maltese: U MNEJN GĦANDU JINGĦATA JEVTANA 60 mg konċentrat sterili cabazitaxel
English: Cabazitaxel induced embryofoetal toxicity in female rats treated intravenously once daily from gestational days 6 through 17 linked with maternal toxicity and consisted of foetal deaths and decreased mean foetal weight associated with delay in skeletal ossification.
Maltese: Cabazitaxel, mogħti darba kuljum minn ġol-vini fil-ġranet 6 sa 17 ta' ġestazzjoni, assoċjati ma' tossiċità materna, ikkawża tossiċità embrijofetali fil-firien nisa li kienet tikkonsista minn mewt tal-feti u tnaqqis fil-piż medju tal-fetu flimkien ma' ttardjar ta' ossifikazzjoni tal-iskeletru.
English: Delay treatment until improvement or resolution, and until neutrophil count is >1,500 cells/mm3, then reduce cabazitaxel dose from 25 mg/m2 to
Maltese: Ipposponi l-kura sakemm l-għadd tan-newtrofili huwa >1,500 ċelluli/mm3, imbagħad naqqas iddoża ta' cabazitaxel minn 25 mg/m2 għal
English: Exposures in animals were lower than those seen in humans receiving clinically relevant doses of cabazitaxel.
Maltese: L-esponiment fl annimali kien inqas minn dak li jkun hemm fl-umani li qed jirċievu dożi klinikament rilevanti ta' cabazitaxel.
English: A hazard ratio < 1 indicates a lower risk of cabazitaxel 20 mg/m2 with respect to 25 mg/m2.
Maltese: Il-proporzjon ta' riskju huwa stmat permezz ta' mudell ta' regressjoni Cox Proportional Hazards Proporzjon ta' periklu < 1 juri riskju inqas għal cabazitaxel 20 mg/m2 meta mqabbel ma' 25 mg/m2.
English: Rectal haemorrhage Dry mouth
Maltese: Idronefrożi Żamma tal-awrina
English: Patients with a history of congestive heart failure, or myocardial infarction within last 6 months, or patients with uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension were not included in the study.
Maltese: Pazjenti li f'dawn l-aħħar 6 xhur kellhom passat mediku ta' insuffiċjenza konġestiva tal-qalb jew ta' infart mijokardijaku jew pazjenti b'arritmiji kardijaċi mhux ikkontrollati, angina pectoris, u/jew pressjoni għolja ma kienux inklużi fl-istudju.
English: Pyrexia
Maltese: ĊITOTOSSIKU
English: Other medicines and JEVTANA
Maltese: Kif taħżen JEVTANA
English: • low blood potassium
Maltese: • livell baxx ta' potassium fid-demm
English: Grade ≥ 3 adverse reactionsb (%)
Maltese: Reazzjonijiet avversi ta' grad ≥ 3b (%) Newtropenija klinika Newtropenija bid-deni
English: People with low blood counts can develop life-threatening infections.
Maltese: Huwa rrakkomandat li t-terapija b'cabazitaxel titwaqqaf sakemm issir magħrufa d-dijanjosi.
English: Interstitial pneumonia/pneumonitis and interstitial lung disease have been reported and may be associated with fatal outcome (see section 4.8).
Maltese: Ġew irrapportati pnewmonja interstizjali/ pulmonite u mard interstizjali tal-pulmun u jistgħu jkunu assoċjati ma' konsegwenzi fatali (ara sezzjoni 4.8).
English: Cabazitaxel had a high plasma clearance of 48.5 l/h (26.4 l/h/m² for a patient with a median BSA of 1.84 m²) and a long terminal half-life of 95 hours.
Maltese: BSA ta' 1.84 m²) u half-life terminali twil ta' 95 siegħa.
English: This can occur if you have a hole in the stomach, food pipe, gut or bowel (gastrointestinal perforation).
Maltese: Dan jista' jseħħ jekk għandek xi toqba fl stonku, kanal tal-ikel, intestin jew musrana (perforazzjoni gastrointestinali).
English: • decrease in the number of red (anaemia), or white blood cells (which are important in fighting infection)
Maltese: • tnaqqis fin-numru ta' ċelluli tad-demm ħomor (anemija) jew bojod (importanti biex jiġġieldu l infezzjonijiet)
English: Concentratesolvent mixture 10 mg/ml
Maltese: 10 mg/ml
English: Cystitis due to radiation recall phenomenon, including haemorrhagic cystitis, were reported uncommonly.
Maltese: Ġiet osservata l-insuffiċjenza renali inkluż każijiet li rriżultaw fil-mewt talpazjent.
English: This resulting concentrate-solvent mixture contains 10 mg/ml of cabazitaxel (at least 6 ml deliverable volume).
Maltese: Madankollu, studju kliniku wera li cabazitaxel (25 mg/m2 mogħti bħala infużjoni waħda ta'
English: Cabazitaxel is extensively metabolised by the liver.
Maltese: Cabazitaxel huwa mmetabolizzat b'mod estensiv mill-fwied.
English: Required amount of concentrate-solvent mixture
Maltese: Taħlita konċentrat solvent
English: Cabazitaxel did not induce mutations in the bacterial reverse mutation (Ames) test.
Maltese: Cabazitaxel ma kkawżax mutazzjonijiet fit-test (Ames) ta' mutazzjoni bir-rivers fil-batterji.
English: PVC infusion containers and polyurethane infusion sets should not be used.
Maltese: M'għandekx tuża reċipjenti tal-infużjoni magħmulin mill-PVC u settijiet tal-infużjoni magħmulin mill-polyurethane.
English: JEVTANA + prednisone n=378
Maltese: prednisone jew prednisolone fl-istudju TROPIC (n=371)
English: Table 2: Reported adverse reactions and haematological abnormalities with cabazitaxel in combination with prednisone or prednisolone in the TROPIC study (n=371)
Maltese: Tabella 2: Reazzjonijiet avversi u anormalitajiet ematoloġiċi rrapportati b'cabazitaxel flimkien ma'
English: This overfill ensures that after dilution with the ENTIRE contents of the accompanying solvent, there is solution containing 10 mg/ml cabazitaxel.
Maltese: Dan iż-żejjed jiżgura li wara d dilwizzjoni bil-kontenut KOLLU tas-solvent li jiġi miegħu, jkun hemm soluzzjoni li fiha 10 mg/ml cabazitaxel.
English: A population pharmacokinetic analysis carried out in 170 patients that included 14 patients with moderate renal impairment (creatinine clearance in the range of 30 to 50 ml/min) and 59 patients with mild renal impairment (creatinine clearance in the range of 50 to 80 ml/min) showed that mild to moderate renal impairment did not have meaningful effects on the pharmacokinetics of cabazitaxel.
Maltese: Analiżi famakokinetika tal popolazzjoni li saret f'170 pazjent li kienet tinkludi 14-il pazjent b'indeboliment renali moderat (tneħħija tal-kreatinina fil-limiti bejn 30 sa 50 ml/min) u 59 pazjent b'indeboliment renali ħafif
English: The adverse reactions reported at rates of at least 5% higher in patients 65 years of age or greater compared to younger patients were diarrhoea (42.9% vs. 32.6%), fatigue (30.2% vs. 19.4%), asthenia (22.4% vs. 13.1%), constipation (20.2% vs. 12.6%), clinical neutropenia (12.9% vs. 6.3%), febrile neutropenia (11.2% vs. 4.6%) and dyspnoea (9.5% vs. 3.4%).
Maltese: 12.6%), innewtropenija klinika (12.9% vs. 6.3%), in-newtropenija bid-deni (11.2% vs. 4.6%) u l-qtugħ ta' nifs (9.5% vs. 3.4%).
English: These patients received cabazitaxel at doses of 10 to 30 mg/m2 weekly or every 3 weeks.
Maltese: Dawn ilpazjenti rċevew cabazitaxel f'dożi ta' 10 sa 30 mg/m2 kull ġimgħa jew kull 3 ġimgħat.
English: (vomiting).
Maltese: Żmien (Xhur)
English: However a clinical study has shown that cabazitaxel (25 mg/m2 administered as a single 1-hour infusion) did not modify the plasma levels of midazolam, a probe substrate of CYP3A.
Maltese: siegħa) ma biddilx il-livelli fil-plażma ta' midazolam, sustrat ta' studju ta' CYP3A.
English: Dysgeusia
Maltese: Alopeċja
English: Other laboratory abnormalities
Maltese: Anormalitajiet oħra ta' laboratorju
English: After initial dilution with the entire solvent, each ml of solution contains 10 mg cabazitaxel.
Maltese: Wara l-ewwel dilwizzjoni bis-solvent kollu, kull millilitru ta' soluzzjoni fih 10 mg ta' cabazitaxel.
English: 7/ 21 weeks
Maltese: 7/ 21 ġimgħat
English: Cabazitaxel demonstrated a broad spectrum of antitumour activity against advanced human tumours xenografted in mice.
Maltese: Intwera li cabazitaxel għandu firxa wiesgħa ta' attività antitumurali kontra tumuri avvanzati umani li ġew ittrapjantati fil-ġrieden.
English: The anticipated complications of overdose would consist of exacerbation of adverse reactions as bone marrow suppression and gastrointestinal disorders.
Maltese: Huwa mistenni li l-kumplikazzjonijiet ta' doża eċċessiva jkunu jikkonsistu minn żieda fir-reazzjonijiet avversi bħal tnaqqis fl-attività tal-mudullun fl-għadam u disturbi gastro-intestinali.
English: NAME OF THE MEDICINAL PRODUCT JEVTANA 60 mg concentrate and solvent for solution for infusion.
Maltese: JEVTANA 60 mg konċentrat u solvent għal soluzzjoni għall-infużjoni.
English: Tofacitinib - Angioedema (EPITT no 18904)
Maltese: Tofacitinib - Anġjoedema (EPITT nru 18904)