FrancophonIA/ELRC3.0 huggingface dataset:
English: A population pharmacokinetic analysis of data in COPD patients after inhalation of Ultibro Breezhaler indicated no significant effect of age, gender and (lean body) weight on the systemic exposure to indacaterol and glycopyrronium.
Maltese: Analiżi farmakokinetika tal-popolazzjoni tad-dejta fost pazjenti b'COPD wara li ħadu Ultibro Breezhaler man-nifs uriet li ma hemmx effett sinjifikanti tal-età, is-sess u (ġisem immejjel) l-piż fuq lespożizzjoni sistemika ta' indicaterol u glycopyrronium.
English: Multipack: 96 (4 packs of 24 x 1) capsules + 4 inhalers.
Maltese: Trab li jittieħed man-nifs, kapsula iebsa Pakkett b'ħafna: 96 (4 pakketti ta' 24 x 1) kapsula + 4 inhalers.
English: In vitro metabolism studies showed consistent metabolic pathways for glycopyrronium bromide between animals and humans.
Maltese: Studji in vitro dwar il-metaboliżmu wrew mogħdijiet metaboliċi konsistenti għal glycopyrronium bromide bejn l-annimali u l-bnedmin.
English: Ultibro Breezhaler is used as an ongoing treatment for your COPD.
Maltese: Ultibro Breezhaler jintuża bħala trattament kontinwu għas-COPD.
English: Over 64 weeks, this reduction was 0.76 puffs per day (p<0.001) compared to tiotropium.
Maltese: Matul 64 ġimgħa, dan it-tnaqqis kien ta' 0.76 sprejjaturi kuljum (p<0.001) imqabbel ma' tiotropium.
English: Headache
Maltese: Sinużite
English: Heart rate effects in healthy volunteers were investigated after a single dose of 4 times the recommended therapeutic dose of Ultibro Breezhaler administered in four dose steps each separated by one hour and compared to the effects of placebo, indacaterol, glycopyrronium and salmeterol.
Maltese: L-effetti fuq ir-rata tal-qalb f'voluntiera b'saħħithom kienu investigati wara doża singola ta' 4 darbiet id-doża terapewtika rrakkomandata ta' Ultibro Breezhaler mogħti f'doża mqassma f'4 stadji kull wieħed imbiegħed mill-ieħor b'siegħa u mqabbel mal-effetti tal-plaċebo, indacaterol, glycopyrronium u salmeterol.
English: Inhalation powder, hard capsule
Maltese: Tiblax il-kapsuli.
English: Over 52 weeks, Ultibro Breezhaler reduced the use of rescue medication by 0.25 puffs per day compared to fluticasone/salmeterol (p<0.001).
Maltese: Matul 52 ġimgħa, Ultibro Breezhaler naqqas l-użu ta' medikazzjoni ta' riskju b'0.25 sprejjaturi kuljum meta mqabbel ma' fluticasone/salmeterol (p<0.
English: Genotoxicity studies did not reveal any mutagenic or clastogenic potential.
Maltese: Studji ġenotossiċi ma wrew l-ebda potenzjal ta' mutaġeniċità jew klastoġeniċità.
English: • Do not swallow the capsule.
Maltese: • Tiblax il-kapsula.
English: Ultibro Breezhaler can be used at the recommended dose in patients with mild to moderate renal impairment.
Maltese: Ultibro Breezhaler jista' jintuża skont id-doża rrakkomandata f'pazjenti b'indeboliment tal-kliewi bejn ħafif u moderat.
English: • runny or stuffy nose.
Maltese: • idejn, għekiesi u saqajn minfuħin.
English: Use of rescue medication
Maltese: TAL-PRODOTT MEDIĊINALI
English: In vitro studies have shown that indacaterol has multi-fold greater agonist activity at beta2-receptors compared to beta1 and beta3-receptors.
Maltese: Studji in vitro wrew li l-indacaterol għandu attività agonista għar-riċetturi-beta2 ħafna drabi aktar meta mqabbla mar-riċetturi-beta1 u beta3.
English: - Keep this leaflet.
Maltese: Attivitajiet ta' kuljum
English: • swelling mainly of the tongue, lips, face or throat (possible signs of angioedema).
Maltese: • nefħa l-aktar tal-ilsien, xufftejn, wiċċ jew griżmejn (sinjali possibbli ta' anġjoedima).
English: During long-term clinical studies, more patients on Ultibro Breezhaler experienced clinically notable changes in blood glucose (4.9%) at the recommended dose than on placebo (2.7%).
Maltese: Waqt studji kliniċi fit-tul, aktar pazjenti mogħtija Ultibro Breezhaler kellhom tibdil notevoli klinikament fil-livell tal-glukosju (4.9%) fid-demm skont id-doża rrakkomandata milli meta ngħata lplaċebo (2.7%).
English: In this pack, you will find a device called an inhaler together with capsules in blister strips.
Maltese: F'dan il-pakkett, se ssib apparat imsejjaħ inhaler, flimkien mal-kapsuli f'folji.
English: Capsules with transparent yellow cap and natural transparent body containing a white to almost white powder, with the product code “IGP110.50” printed in blue under two blue bars on the body and the company logo ( ) printed in black on the cap.
Maltese: Il-kapsuli għandhom tapp isfar trasparenti u qafas trasparenti natural u għandhom trab minn abjad għal kważi abjad u għandhom il-kodiċi tal-prodott “IGP11050” stampat bil-blu taħt żewġ strixxi blu fuq ilqafas u l-marka tal-kumpanija ( ) stampata bl-iswed fuq it-tapp.
English: Narrow-angle glaucoma
Maltese: TA' KIF JINGĦATA
English: Beta2-adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to produce adverse cardiovascular effects.
Maltese: L-agonisti beta2-adrenerġiċi jistgħu jikkawżaw ipokalimja qawwija f'uħud mill-pazjenti, li kapaċi tikkawża effetti kardjovaskulari avversi.
English: On the first day of treatment, inspiratory capacity under exercise was significantly improved (LS mean treatment difference 250 ml, p<0.001) compared to placebo.
Maltese: Fl-ewwel jum ta' trattament, il-ħila ispiratorja waqt l-eżerċizzju tjiebet sinjifikament (differenza fil-medja tal-kura ta' LS ta' 250 ml, p<0.001) imqabbel ma' plaċebo.
English: The use of Ultibro Breezhaler by breast-feeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant (see section 5.3).
Maltese: L-użu ta' Ultibro Breezhaler minn nisa jreddgħu għandu jitqies biss jekk il-benefiċċju mistenni għall-mara hu akbar minn kull possibbiltà ta' riskju għat-tarbija (ara sezzjoni 5.3).
English: In Phase III studies, bronchodilator effects were seen within 5 minutes after the first dose and were maintained over the 24-hour dosing interval from the first dose.
Maltese: Skont studji f'Fażi III, l-effetti bronkodilataturi dehru fi żmien 5 minuti wara l-għoti tal-ewwel doża u nżammu tul 24 siegħa wara li ngħatat l-ewwel doża.
English: Multipack comprising 25 packs (6 capsules + 1 inhaler)
Maltese: Pakkett b'ħafna li jinkludi 25 pakkett (6 kapsuli + inhaler wieħed)
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, adrenergics in combination with anticholinergics, ATC code: R03AL04
Maltese: Mediċini għal mard li jdejjaq il-passaġġi tal-arja, adrenerġiċi flimkien ma' antikolinerġiċi, Kodiċi ATC:
English: Grade>3 n (%)
Maltese: Grad>3 n (%)
English: • mental confusion
Maltese: • konfużjoni mentali
English: Concentrate Polysorbate 80 Citric acid
Maltese: Polysorbate 80 Citric acid
English: Environmental Risk Assessment (ERA)
Maltese: Rapport ta' stima tar-riskju ambjentali (ERA)
English: • fever (high temperature).
Maltese: • deni (temperatura għolja).
English: • corticosteroid (dexamethasone 8 mg or equivalent), and
Maltese: • kortikosterojd (dexamethasone 8 mg jew ekwivalenti), u
English: Haematological abnormalitiesc (%)
Maltese: Anormalitajiet ematoloġiċic (%)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/676/001
Maltese: EU/1/11/676/001
English: Date of latest renewal: 19 November 2015
Maltese: Data tal-ewwel awtorizzazzjoni: 17 Marzu 2011 Data tal-aħħar tiġdid: 19 Novembru 2015
English: • H2 antagonist (ranitidine or equivalent) (see section 4.4).
Maltese: • antagonist H2 (ranitidine jew xi ekwivalenti) (ara sezzjoni 4.4).
English: • antihistamine (dexchlorpheniramine 5 mg or diphenhydramine 25 mg or equivalent),
Maltese: • antistamin (dexchlorpheniramine 5 mg jew diphenhydramine 25 mg jew ekwivalenti),
English: The mean AUC was 991 ng.h/ml (CV: 34%).
Maltese: Il-medja tal-AUC kienet ta' 991 ng.h/ml (CV: 34%).
English: Thrombocytopeniaa 176 (47.4) Febrile neutropenia
Maltese: Tromboċitopenijaa 176 (47.4)
English: Colitis, enterocolitis, gastritis, neutropenic enterocolitis have been observed.
Maltese: Ġew osservati kolite, enterokolite, gastrite u enterokolite newtropenika.
English: Concentrate vial (60 mg - 1.5 ml)
Maltese: Kunjett tal-konċentrat (60 mg - 1.5 ml)
English: • Severe hepatic impairment (total bilirubin >3 x ULN).
Maltese: • Indeboliment epatiku sever (total tal-bilirubin >3 x ULN).
English: Paediatric population See section 4.2
Maltese: Popolazzjoni pedjatrika Ara sezzjoni 4.2
English: Ethanol 96% Water for injections
Maltese: Ethanol 96 % Ilma għall-injezzjonijiet
English: Risk of serious gastrointestinal reactions
Maltese: Riskju ta' reazzjonijiet gastrointestinali serji
English: From 25 to 20 mg/m2: 128 (21.5%) From 20 to 15 mg/m2: 19 (3.2%) From 15 to 12 mg/m2: 1 (0.2%)
Maltese: Minn 25 għal 20 mg/m2: 128 Minn 20 għal 15 mg/m2: 19 (3.2%) Minn 15 għal 12 mg/m2: 1 (0.2%)
English: Weight decreased Aspartate aminotransferase increased
Maltese: Tnaqqis fil-piż Żieda fl-aspartate aminotransferase
English: JEVTANA contains ethanol (alcohol)
Maltese: JEVTANA fih l-ethanol (l-alkoħol)
English: A statistically significantly higher risk of PSA progression in patients with the 20 mg/m2 dose with respect to the 25 mg/m2 dose was observed (HR 1.195 ; 95%CI: 1.025 to 1.393).
Maltese: Ġie osservat riskju statistikament sinifikanti ogħla ta' progressjoni fil-PSA f'pazjenti bid doża ta' 20 mg/m2 meta mqabbel mad-doża ta' 25 mg/m2 (HR 1.195 ; 95%CI: 1.025 to 1.393).
English: From 20 to 15 mg/m2: 58 (10.0%) From 15 to 12 mg/m2: 9 (1.6%)
Maltese: Minn 20 għal 15 mg/m2: 58 Minn 15 għal 12 mg/m2: 9 (1.6%)
English: The safety profile of cabazitaxel 25 mg/m2 observed in study EFC11785 was qualitatively and quantitatively similar to that observed in the study EFC6193.
Maltese: Il-profil ta' sigurtà ta' cabazitaxel 25 mg/m2 li ġie osservat fl-istudju EFC11785 kien kwalitativament u kwantitativament simili għal dak osservat fl-istudju EFC6193.
English: The solvent contains 573.3 mg ethanol 96% (15% v/v), equivalent to 14 ml of beer or 6 ml of wine.
Maltese: Is-solvent fih 573.3 mg ta' ethanol 96% (15 %v/v), ekwivalenti għal 14 ml ta' birra jew 6 ml ta' inbid.
English: Therefore the risk of interaction with substrates of MRP, OCT1, PgP, BCRP and OATP1B3 is unlikely in vivo at the dose of 25 mg/m2.
Maltese: interazzjoni mas-sustrati ta' MRP, OCTI, PgP, BCRP u OATP1B3 b'doża ta' 25 mg/m2.
English: There is no potential risk of inhibition of medicinal products that are substrates of other CYP enzymes (1A2, 2B6, 2C9, 2C8, 2C19, 2E1, and 2D6) as well as no potential risk of induction by cabazitaxel on medicinal products that are substrates of CYP1A, CYP2C9, and CYP3A.
Maltese: M'hemm ebda riskju potenzjali ta' inibizzjoni ta' prodotti mediċinali li huma sustrati ta' enżimi CYP oħra (1A2, 2B6, 2C9, 2C8, 2C19, 2E1, and 2D6) kif ukoll m'hemm ebda riskju potenzjali ta' stimulazzjoni minn cabazitaxel fuq prodotti mediċinali li huma sustrati ta' CYP1A, CYP2C9, u
English: The active substance is cabazitaxel.
Maltese: Is-sustanza attiva hija cabazitaxel.
English: • you have kidney problems.
Maltese: • għandek problemi fil-kliewi.
English: Hazard Ratioa versus CBZ25+PRED 1-sided 98.89% UCI 1-sided 95% LCI CBZ20=Cabazitaxel 20 mg/m2, CBZ25=Cabazitaxel 25 mg/m2, PRED=Prednisone/Prednisolone CI=confidence interval, LCI=lower bound of the confidence interval, UCI=upper bound of the confidence interval a Hazard ratio is estimated using a Cox Proportional Hazards regression model.
Maltese: Proporzjon ta' Riskju a kontra CBZ25+PRED 1-sided 98.89% UCI 1-sided 95% LCI CBZ20=Cabazitaxel 20 mg/m2, CBZ25=Cabazitaxel 25 mg/m2, PRED=Prednisone/Prednisolone CI=intervall ta' kunfidenza, LCI=il-limitu t'isfel tal-intervall ta' kunfidenza, UCI= il-limitu ta' fuq talintervall ta' kunfidenza a
English: • Neutrophil counts less than 1,500/mm3.
Maltese: • Għadd tan-newtrofili inqas minn 1,500/mm3.
English: Pharmacotherapeutic group: Antineoplastic agents, taxanes, ATC code: L01CD04
Maltese: Sustanzi antineoplastiċi, taxanes, Kodiċi ATC:
English: Adverse reactions are listed in table 2 according to MedDRA system organ class and frequency categories.
Maltese: Ir-reazzjonijiet avversi huma mniżżla f'tabella 2 f'kategoriji skont is-sistema tal-klassifika tal-organi MedDRA u l-frekwenzi.
English: Figure 1: Kaplan Meier overall survival curves (EFC6193)
Maltese: Figura 1: Il-kurvi Kaplan Meier tas-sopravivenza totali
English: System Organ Class Adverse reaction
Maltese: Sistema talKlassifika tal-Organi
English: CBZ20=Cabazitaxel 20 mg/m2, CBZ25=Cabazitaxel 25 mg/m2, PRED=Prednisone/Prednisolone a All grade adverse reactions with an incidence higher than 10% b Grade ≥ 3 adverse reactions with an incidence higher than 5% c Based on laboratory values
Maltese: CBZ20=Cabazitaxel 20 mg/m2, CBZ25=Cabazitaxel 25 mg/m2, PRED=Prednisone/Prednisolone a Reazzjonijiet avversi ta' kull grad b'inċidenza ogħla minn 10 %
English: Patients had to have neutrophils >1,500/mm3, platelets >100,000/mm3, haemoglobin >10 g/dl, creatinine <1.5 x ULN, total bilirubin <1 x ULN, AST and ALT <1.5 x ULN.
Maltese: Il-pazjenti ried ikollhom in-newtrofili >1,500/mm3, il-plejtlits >100,000/mm3, l-emoglobina >10 g/dl, il-krejatinina <1.5 x ULN, it-total talbilirubin <1 x ULN, AST u ALT <1.5 x ULN.
English: Intensity of the adverse reactions is graded according to CTCAE 4.0 (grade ≥3 = G≥3).
Maltese: Il-grad ta' intensità tar-reazzjonijiet avversi ġie maħdum skont is-CTCAE 4.0 (grad ≥ 3 = G≥ 3).
English: 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion
Maltese: Soluzzjoni għallinfużjoni ta' 5% glucose jew ta' sodium chloride 9 mg/ml (0.9%)
English: Risk of cardiac arrhythmias
Maltese: Riskju ta' arritmiji kardijaċi
English: Cardiac disorders* Atrial fibrillation Tachycardia
Maltese: Fibrillazzjoni atrijali Takikardija
English: Gastrointestinal (GI) hemorrhage and perforation, ileus, colitis, including fatal outcome, have been reported in patients treated with cabazitaxel (see section 4.8).
Maltese: Emorraġija gastrointestinali (GI) u perforazzjoni, ileus, kolite, inkluż avveniment fatali, ġew irrappurtati f'pazjenti kkurati b'cabazitaxel (ara sezzjoni 4.8).
English: The median number of cycles was 6 in the JEVTANA group and 4 in the mitoxantrone group.
Maltese: In-numru medjan ta' ċikli fil-grupp ta'JEVTANA kien 6 u 4 fil-grupp ta' mitoxantrone.
English: Therefore, no pharmacokinetic interaction of cabazitaxel on warfarin is expected in vivo.
Maltese: mhi mistennija ebda interazzjoni farmakokinetika ta' cabazitaxel fuq warfarin.
English: This medicine contains 15% v/v ethanol (alcohol), equivalent to 14 ml of beer or 6 ml of wine.
Maltese: Din il-mediċina fiha 15% v/v ethanol (alkoħol), ekwivalenti għal 14 ml birra jew 6 ml inbid.
English: The maximum tolerated dose (MTD) of cabazitaxel was 20 and 15 mg/m2, respectively.
Maltese: L-ogħla doża ttollerata (MTD) ta' cabazitaxel kienet ta' 20 u 15 mg/m2, rispettivament.
English: Patients treated with cabazitaxel may receive prophylactic G-CSF, as per American Society of Clinical Oncology (ASCO) guidelines and/or current institutional guidelines, to reduce the risk or manage neutropenia complications (febrile neutropenia, prolonged neutropenia or neutropenic infection).
Maltese: American Society of Clinical Oncology (ASCO) u/jew il-linji gwida istituzzjonali kurrenti, sabiex jitnaqqas ir-riskju jew jiġu kkontrollati l-kumplikazzjonijiet tan-newtropenija (newtropenija bid-deni, newtropenija fit-tul jew infezzjoni newtropenika).
English: The volume of distribution (Vss) was 4870 l (2640 l/m² for a patient with a median BSA of 1.84 m²) at steady state.
Maltese: Il-volum ta' distribuzzjoni (Vss) kien ta' 4870 l (2640 l/m² għal pazjent b'medjan għall-BSA ta' 1.84 m²) fi stat fiss.
English: It could take approximately 45 seconds.
Maltese: Tista' tieħu madwar 45 sekonda.
English: The risk of interaction with OATP1B1 substrates (e.g. statins, valsartan, repaglinide) is possible, notably during the infusion duration (1 hour) and up to 20 minutes after the end of the infusion.
Maltese: OATP1B1 (eż. statins, valsartan, repaglinide) huwa possibbli, l-aktar waqt il-ħin tal-infużjoni (siegħa) u sa 20 minuta wara t-tmiem tal-infużjoni.
English: Cabazitaxel is mainly bound to human serum albumin (82.0%) and lipoproteins (87.9% for HDL, 69.8% for LDL, and 55.8% for VLDL).
Maltese: cabazitaxel isir l-iżjed mal-albumina umana fis-serum (82.0%) u l-lipoproteini (87.9% għall-HDL,
English: The risk of interaction with OATP1B1 transporter is possible, notably during the infusion duration (1 hour) and up to 20 minutes after the end of the infusion (see section 4.5).
Maltese: interazzjoni ma' trasportatur ta' OATP1B1 huwa possibbli , l-aktar waqt il-ħin tal-infużjoni (siegħa) u sa 20 minuta wara t-tmiem tal-infużjoni (ara sezzjoni 4.5).
English: Risk of neutropenia
Maltese: Riskju ta' newtropenija
English: The number of patients who completed the study treatment (10 cycles) was respectively 29.4% and 13.5% in the JEVTANA group and in the comparator group.
Maltese: In-numru ta' pazjenti li spiċċaw it-trattament taħt studju (10 cikli) kienu rispettivament 29.4% u 13.5% fil-grupp ta' JEVTANA u fil-grupp tal-komparatur.
English: Incidence of grade ≥3 neutropenia based on laboratory data was 81.7%.
Maltese: L-inċidenza tan-newtropenija ta' grad ≥ 3 ibbażata fuq dejta mil-laboratorju kienet ta' 81.7 %.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 4.5 ml (ethanol 96% and water for injections).
Maltese: INDIVIDWALI 4.5 ml (ethanol 96% u ilma għall-injezzjonijiet).
English: In patients with moderate hepatic impairment (total bilirubin >1.5 to ≤ 3.0 x ULN), the maximum tolerated dose (MTD) was 15 mg/m2.
Maltese: F'pazjenti b'indeboliment epatiku moderat (total tal-bilirubin >1.5 sa ≤ 3.0 x ULN), l-ogħla doża ttollerata (MTD-maximum tolerated dose) kienet ta' 15 mg/m2.
English: Fatal ventricular fibrillation was reported in 1 patient (0.3%), and cardiac arrest in 2 patients (0.5%).
Maltese: Ġie irrapportat li lfibrillazzjoni ventrikulari kkawżat il-mewt f'pazjent wieħed (0.3 %) u 2 pazjenti kellhom arrest kardijaku (0.5 %).
English: An in-line filter of 0.22 micrometer nominal pore size (also referred to as 0.2 micrometer) is recommended during administration.
Maltese: Filtru tal-pajp tad-dripp ta' daqs nominali ta' apertura ta' 0.22 mikrometru (jirreferu għalih ukoll bħala 0.2 mikrometru) huwa rrakkomandat waqt l-għoti.
English: These medicines include the following: - ketoconazole, rifampicin (for infections); - carbamazepine, phenobarbital or phenytoin (for seizures); - St John's Wort (Hypericum perforatum) (herbal remedy for depression and other conditions); - statins (such as simvastatin, lovastatin, atorvastatin, rosuvastatin, or pravastatin) (for reducing the cholesterol in your blood); - valsartan (for hypertension); - repaglinide (for diabetes).
Maltese: - ketoconazole, rifampicin (għall-infezzjonijiet); - carbamazepine, phenobarbital jew phenytoin (għall-epilessija); - St John's Wort (Hypericum perforatum) (rimedju mill-ħxejjex għad-depressjoni u kundizzjonijiet oħra);
English: This was confirmed by a dedicated comparative pharmacokinetic study in solid cancer patients with normal renal function (8 patients), moderate (8 patients) and severe (9 patients) renal impairment, who received several cycles of cabazitaxel in single IV infusion up to 25 mg/m2.
Maltese: Dan ġie kkonfermat b'studju farmakokinetiku komparattiv magħmul b'mod speċifiku f'pazjenti b'kanċer solidu b'funzjoni renali normali (8 pazjenti), moderat (8 pazjenti) u sever (9 pazjenti), li rċevew ħafna ċikli ta' cabazitaxel f'infużjoni IV waħda sa 25 mg/m2.
English: Excipient with known effect Each vial of solvent contains 573.3 mg of ethanol 96%.
Maltese: Kull kunjett ta' solvent fih 573.3 mg ta' ethanol 96 %.
English: No major deviation to the dose proportionality was observed from 10 to 30 mg/m² in patients with advanced solid tumours (n=126).
Maltese: Ma ġietx osservata xi devjazzjoni kbira fil-proporzjonalità tad-doża minn 10 sa 30 mg/m² f'pazjenti b'tumuri avanzati solidi (n=126).
English: In vitro, the binding of cabazitaxel to human serum proteins was 89-92% and was not saturable up to 50,000 ng/ml, which covers the maximum concentration observed in clinical studies.
Maltese: In vitro, l-irbit ta' cabazitaxel mal-proteini umani fis-serum kien ta' 89-92% u s-saturazzjoni ntlaħqet mal-50,000 ng/ml, li jkopri l-konċentrazzjoni massima osservata fl-istudji kliniċi.
English: Grade ≥ 3 anaemia
Maltese: Newtropenija ta' grad ≥ 3 Anemija ta' grad ≥ 3
English: Repeated administration of rifampin (600 mg once daily), a strong CYP3A inducer, resulted in an increase in cabazitaxel clearance of 21% corresponding to a decrease in AUC of 17%.
Maltese: Għoti ripetut ta' rifampicin (600 mg darba kuljum), induttur qawwi ta' CYP3A, wassal għal żieda ta' 21% fit-tneħħija ta' cabazitaxel li tikkorrispondi għal tnaqqis ta' 17% fl-AUC.
English: In vitro cabazitaxel did not inhibit Multidrug-Resistant Proteins (MRP): MRP1 and MRP2 or Organic Cation Transporter (OCT1).
Maltese: In vitro, cabazitaxel ma kkawżax l-inibizzjoni tal-Multidrug-Resistant Proteins (MRP): MRP1 u
English: • infections or risk of infections
Maltese: • infezzjonijiet jew riskju ta' infezzjonijiet
English: CYP3A inducers
Maltese: Inibituri ta' CYP3A
English: Table 4 - Overall survival in EFC11785 study in cabazitaxel 25 mg/m2 arm versus cabazitaxel 20 mg/m2 arm (Intent-to-treat analysis) - Efficacy primary endpoint
Maltese: Tabella 4 - Sopravivenza totali fl-istudju EFC11785 fil-fergħa ta' cabazitaxel 25 mg/m2 kontra l fergħa ta' cabazitaxel 20 mg/m2 (Intent-to-treat analysis) - Punt finali primarju ta' effikaċja
English: Cabazitaxel is extensively metabolised in the liver (>95%), mainly by the CYP3A isoenzyme (80% to 90%).
Maltese: Cabazitaxel jiġi mmetabolizzat b'mod estensiv fil-fwied (>95%), l-iżjed mill-isoenżima CYP3A (80% sa 90%).
English: The PSA response was 39.2% in patients on JEVTANA arm (95%CI: 33.9-44.5) versus 17.8% of patients on mitoxantrone (95%CI: 13.7-22.0), p=0.0002.
Maltese: Fil-pazjenti fil-fergħa ta' JEVTANA, ir-rispons fil-PSA kien ta' 39.2% (95%CI: 33.9-44.5) kontra 17.8% tal-pazjenti fuq mitoxantrone (95% CI: 13.7-22.0), p=0.0002.
English: There was no significant difference in overall survival in this group of patients (HR (95%CI) 0.96 (0.49-1.86)).
Maltese: F'dan il-grupp ta' pazjenti ma kien hemm ebda differenza sinifikanti fis-sopravivenza totali (HR (95%CI) 0.96 (0.49-1.86)).
English: A population pharmacokinetic analysis was carried out in 170 patients including patients with advanced solid tumours (n=69), metastatic breast cancer (n=34) and metastatic prostate cancer (n=67).
Maltese: .2 Tagħrif farmakokinetiku Sar analiżi farmakokinetiku tal-popolazzjoni f'170 pazjent li kien jinkludi pazjenti b'tumuri avanzati solidi (n=69), kanċer tas-sider metastatiku (n=34) u kanċer tal-prostata metastatiku (n=67).
English: Secondary endpoints included Progression Free Survival [PFS (defined as time from randomization to tumour progression, Prostatic Specific Antigen (PSA) progression, pain progression, or death due to any cause, whichever occurred first], Tumour Response Rate based on Response Evaluation Criteria in Solid Tumours (RECIST), PSA Progression (defined as a ≥25% increase or >50% in PSA non-responders or responders respectively), PSA response (declines in serum PSA levels of at least 50%), pain progression [assessed using the Present Pain Intensity (PPI) scale from the McGill-Melzack questionnaire and an Analgesic Score (AS)] and pain response (defined as 2-point greater reduction from baseline median PPI with no concomitant increase in AS, or reduction of ≥50% in analgesic use from baseline mean AS with no concomitant increase in pain).
Maltese: (PSA) , progressjoni fl-uġigħ jew mewt minn kwalunkwe kawża, liema waħda minnhom seħħet l ewwel.], ir-Rata ta' Rispons tat-Tumur ibbażata fuq il-Kriterji ta' Evalwazzjoni tar-Rispons f'Tumuri Solidi (RECIST), progressjoni fil-PSA (definit bħala żieda ta' ≥25% jew >50% fil-PSA f'dawk li mhux qed jirrispondu jew li qed jirrispondu, rispettivament), rispons tal-PSA (tnaqqis fil-livelli tal
English: Step 1.5
Maltese: Fażi 1.5
English: It belongs to a group of medicines called “taxanes” used to treat cancers.
Maltese: Jagħmel parti minn grupp ta' mediċini msejħa “taxanes” użati fil-kura tal-kanċers.
English: 1,500 /mm3),
Maltese: ≥1,500/mm3 (ara sezzjoni 4.3).