FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, exploratory analysis showed that the impact of covariates (i.e., renal function, race and age) on the pharmacokinetics of total trastuzumab and DM1 was limited and was not clinically relevant.
Maltese: Barra dan, analiżi esploratorja wriet li l-impatt ta' kovarjanti (jiġifieri, funzjoni renali, razza u età) fuq il-farmakokinetika ta' trastuzumab u DM1 totali kien limitat u ma kienx klinikament rilevanti.
English: Kadcyla 100 mg powder for concentrate for solution for infusion Kadcyla is provided in 15 mL (100 mg) Type 1 glass vial closed with a grey-butyl rubber stopper coated with fluoro-resin laminate, and sealed with an aluminium seal with a white plastic flip-off cap.
Maltese: Kadcyla huwa pprovdut f'kunjett tal-ħġieġ tat-Tip 1 ta' 15 mL (100 mg) magħluq b'tapp griż tallastku butyl miksi b'kisja ta' fluoro-resin, u ssiġillat b'siġill tal-aluminju b'għatu tal-plastik abjad li jitqaċċat.
English: Independent of race, the incidence of Grade 3 or 4 events (< 50,000/mm3) was 8.7% in patients with MBC treated with trastuzumab emtansine and 5.7% in patients with EBC.
Maltese: 3) kienet ta' 8.7% f'pazjenti b'MBC ittrattati bi trastuzumab emtansine u 5.7% f'pazjenti b'EBC.
English: Infusion-related reactions were reported in 4.0% of patients in MBC clinical studies with trastuzumab emtansine, with six Grade 3 and no Grade 4 events reported.
Maltese: Reazzjonijiet relatati mal-infużjoni kienu rrappurtati f'4.0% tal-pazjenti fl-istudji kliniċi dwar MBC b'trastuzumab emtansine, b'rapport ta' sitt avvenimenti ta' Grad 3 u bl-ebda rapport ta' avvenimenti ta' Grad 4.
English: Tumor prognostic characteristics including hormone receptor status (positive: 72.3%, negative: 27.7%), clinical stage at presentation (inoperable: 25.3%, operable: 74.8%) and pathological nodal status after preoperative therapy (node positive: 46.4%, node negative or not evaluated: 53.6%) were similar in the study arms.
Maltese: 3%, tista' ssir kirurġija: 74.8%) u stat patoloġiku tal-glandoli wara terapija ta' qabel il-kirurġija (glandoli b'test pożittiv: 46.4%, glandoli b'test negattiv jew li ma ġewx evalwati: 53.6%) kienu simili fil-gruppi tal-istudju.
English: · DM1, the cytotoxic component of trastuzumab emtansine, binds to tubulin.
Maltese: ● DM1, il-komponent ċitotossiku ta' trastuzumab emtansine, jeħel ma' tubulin.
English: The appropriate amount of solution should be withdrawn from the vial and added to an infusion bag containing 250 mL of sodium chloride 4.5 mg/mL (0.45%) solution for infusion or sodium chloride 9 mg/mL (0.9%) solution for infusion.
Maltese: L-ammont xieraq ta' soluzzjoni għandu jinġibed mill-kunjett u għandu jiġi miżjud f'borża tal-infużjoni li jkun fiha 250 mL ta' soluzzjoni għall-infużjoni ta' 4.5 mg/mL (0.45%) sodium chloride jew soluzzjoni għall-infużjoni ta' 9 mg/mL (0.9%) sodium chloride.
English: Administration of trastuzumab emtansine was well tolerated in rats and monkeys at doses up to 20 and 10 mg/kg, respectively, corresponding to 2040 mg DM1/m2 in both species, which is approximately equivalent to the clinical dose of trastuzumab emtansine in patients.
Maltese: L-għoti ta' trastuzumab emtansine kien ittollerat tajjeb fil-firien u x-xadini b'dożi sa 20 u 10 mg/kg, rispettivament, li jikkorrispondu għal 2040 µg DM1/m fiż-żewġ speċi, li bejn wieħed u ieħor huma ekwivalenti għad-doża klinika ta' trastuzumab emtansine fil-pazjenti.
English: Primary endpoints IRC-assessed progression-free survival (PFS) Number (%) of patients with event Median duration of PFS (months) Hazard ratio (stratified*) 95% CI for Hazard ratio p-value (Log-rank test, stratified*) Overall Survival (OS)** Number (%) of patients who died Median duration of survival (months) Hazard ratio (stratified*) 95% CI for Hazard ratio p-value (Log-rank test*) Key secondary endpoints Investigator-assessed PFS Number (%) of patients with event Median duration of PFS (months) Hazard ratio (95% CI) p-value (Log-rank test*) Objective response rate (ORR) Patients with measurable disease Number of patients with OR (%) Difference (95% CI) p-value (Mantel-Haenszel chi-squared test*) Duration of objective response (months) Number of patients with OR Median 95% CI OS: overall survival; PFS: progression-free survival; ORR: objective response rate; OR: objective response; IRC: independent review committee; HR: hazard ratios; CI: confidence interval * Stratified by: world region (United States, Western Europe, other), number of prior chemotherapeutic regimens for locally advanced or metastatic disease (0-1 vs. > 1), and visceral vs. non-visceral disease.
Maltese: IRC: kumitat ta' analiżi indipendenti; HR: proporzjonijiet ta' periklu; CI: intervall ta' konfidenza * Stratifikat skont: ir-reġjun tad-dinja (Stati Uniti, Ewropa tal-Punent, oħrajn), in-numru ta' korsijiet kimoterapewtiċi minn qabel għall-marda avanzata lokalment jew metastatika (0-1 kontra > 1), u marda tal-vixxri kontra marda mhux tal-vixxri . ** L-analiżi interim għal OS saret meta kienu osservati 331 avveniment.
English: Due date
Maltese: 2 Kurva
English: For dose modifications in the event of hypersensitivity reactions, see sections 4.2 and 4.4.
Maltese: Għall-modifikazzjonijiet fid-doża f'każ ta' reazzjonijiet ta' sensittività eċċessiva, ara sezzjonijiet 4.2 u 4.4.
English: Randomization was stratified by clinical stage at presentation (operable vs. inoperable), hormone receptor status, preoperative HER2-directed therapy (trastuzumab, trastuzumab plus additional HER2-directed agent[s]), and pathological nodal status evaluated after preoperative therapy.
Maltese: Randomisation kienet stratifikata skont l-istadju kliniku fil-preżentazzjoni (tista' ssir kirurġija vs. ma tistax issir kirurġija), l-istat tar-riċettur tal-ormon, it-terapija mmirata lejn HER2 ta' qabel il-kirurġija (trastuzumab, trastuzumab flimkien ma' sustanza/i addizzjonali mmirati lejn HER2), u l-istat patoloġiku tal-glandoli evalwati wara t-terapija ta' qabel il-kirurġija.
English: Cases of interstitial lung disease (ILD), including pneumonitis, some leading to acute respiratory distress syndrome or a fatal outcome, have been reported in clinical studies with trastuzumab emtansine (see section 4.8).
Maltese: Każijiet ta' mard tal-interstizju tal-pulmun (ILD - interstitial lung disease), inkluż pulmonite, b'uħud iwasslu għal sindrome ta' diffikultà respiratorja akuta jew għal riżultat fatali, kienu rrappurtati fi studji kliniċi b'trastuzumab emtansine (ara sezzjoni 4.8).
English: Instructions for reconstitution · Kadcyla 100mg: using a sterile syringe, slowly inject 5 mL of sterile water for injection into the
Maltese: ● Kadcyla 100mg: bl-użu ta' siringa sterili, injetta bil-mod 5 mL ta' ilma għall-injezzjoni sterili fil-kunjett ta' 100 mg trastuzumab emtansine.
English: The use of 0.20 or 0.22 micron in-line polyethersulfone (PES) filter is required for the infusion when the concentrate for infusion is diluted with sodium chloride 9 mg/mL (0.9%) solution for infusion.
Maltese: L-użu ta' filtru in-line ta' 0.20 jew 0.22 mikroni magħmul minn polyethersulfone (PES) huwa meħtieġ għall-infużjoni meta l-konċentrat għall-infużjoni jiġi dilwit b'soluzzjoni għall-infużjoni ta' 9 mg/mL (0.9%) sodium chloride.
English: If sodium chloride 9 mg/mL (0.9%) solution for infusion is used for infusion, a 0.20 or 0.22 micron in-line polyethersulfone (PES) filter is required.
Maltese: Jekk tintuża soluzzjoni għall-infużjoni ta' 9 mg/mL (0.9%) sodium chloride, huwa meħtieġ filtru fil-pajp ta' 0.20 jew 0.22 mikroni magħmul minn polyethersulfone (PES).
English: Patients were randomised to receive trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks (n = 67) or trastuzumab 8 mg/kg intravenous loading dose followed by 6 mg/kg intravenously every 3 weeks plus docetaxel 75-100 mg/m2 intravenously every
Maltese: Il-pazjenti kienu randomised biex jirċievu trastuzumab emtansine 3.6 mg/kg fil-vini kull 3 ġimgħat (n = 67) jew doża għolja tal-bidu ta' trastuzumab 8 mg/kg fil-vini segwit minn 6 mg/kg fil-vini kull 3 ġimgħat flimkien ma' docetaxel
English: If concomitant use of strong CYP3A4 inhibitors is unavoidable, consider delaying trastuzumab emtansine treatment until the strong CYP3A4 inhibitors have cleared from the circulation (approximately 3 elimination half-lives of the inhibitors) when possible.
Maltese: Jekk użu fl-istess ħin ta' inibituri qawwija ta' CYP3A4 huwa inevitabbli, għandu jiġi kkunsidrat li t-trattament b'trastuzumab emtansine jiġi ttardjat sakemm l-inibituri qawwija ta' CYP3A4 ikunu tneħħew miċ-ċirkolazzjoni (madwar 3 half-lives taleliminazzjoni tal-inibituri) meta possibbli.
English: · Kadcyla 100mg: One vial of powder for concentrate for solution for infusion contains 100 mg of trastuzumab emtansine.
Maltese: ● Kadcyla 100 mg: Kunjett wieħed ta' trab għal konċentrat għal soluzzjoni għall-infużjoni fih 100 mg ta' trastuzumab emtansine.
English: Kadcyla.
Maltese: Kft.
English: The median duration of overall survival was 29.9 months in the trastuzumab emtansine arm compared with 25.9 months in the lapatinib plus capecitabine arm. At the time of the descriptive follow-up overall survival analysis, a total of 27.4% of the patients had crossed over from the lapatinib plus capecitabine arm to the trastuzumab emtansine arm.
Maltese: Fiż-żmien tal-analiżi deskrittiva ta' segwitu ta' sopravivenza globali, total ta' 27.4% tal-pazjenti kienu qalbu mill-grupp ta' lapatinib flimkien ma' capecitabine għall-grupp ta' trastuzumab emtansine.
English: Increase in serum transaminases (Grade 1-4) has been observed during treatment with trastuzumab emtansine in clinical studies (see section 4.4).
Maltese: Żieda fit-transaminases fis-serum (Grad 1-4) kienet osservata waqt trattament b'trastuzumab emtansine fl-istudji kliniċi (ara sezzjoni 4.4). Elevazzjonijiet tat-transaminase ġeneralment kienu temporanji.
English: For patients randomised to trastuzumab emtansine, the median age was 53 years, most patients were female (99.8%), the majority were Caucasian (72%), and 57% had oestrogen-receptor and/or progesterone-receptor positive disease.
Maltese: Għall-pazjenti randomised għal trastuzumab emtansine, l-età medjana kienet ta' 53 sena, il-biċċa l-kbira tal-pazjenti kienu nisa (99.8%), il-maġġoranza kienu Kawkasi (72%), u 57% kellhom marda pożittiva għar-riċettur tal-oestroġen u/jew tal-progesterone.
English: Kadcyla100 mg powder for concentrate for solution for infusion Kadcyla 160 mg powder for concentrate for solution for infusion trastuzumab emtansine
Maltese: Kadcyla 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Kadcyla 160 mg trab għal konċentrat għal soluzzjoni għall-infużjoni trastuzumab emtansine
English: Kadcyla 160 mg powder for concentrate for solution for infusion.
Maltese: Kadcyla 160 mg trab għal konċentrat għal soluzzjoni għall-infużjoni.
English: Patients treated with trastuzumab emtansine should have HER2 positive tumour status, defined as a score of 3 + by immunohistochemistry (IHC) or a ratio of ≥ 2.0 by in situ hybridization (ISH) or by fluorescence in situ hybridization (FISH) assessed by a CE-marked In Vitro Diagnostic (IVD) medical device.
Maltese: Pazjenti ttrattati b'trastuzumab emtansine għandu jkollhom stat tat-tumur pożittiv għal HER2, definit bħala punteġġ ta' 3 + permezz ta' immunoistokimika (IHC - immunohistochemistry) jew proporzjon ta' ≥ 2.0 permezz ta' in situ hybridisation (ISH) jew permezz ta' fluorescence in situ hybridisation
English: · Neurological problems: Kadcyla can damage nerves.
Maltese: Kadcyla jista' jagħmel ħsara lin-nervituri.
English: Estimates of 3 years IDFS rates were 88.3% vs. 77.0% in trastuzumab emtansine vs. trastuzumab arms, respectively.
Maltese: 77.0% fil-gruppi ta' trastuzumab emtansine vs. trastuzumab, rispettivament.
English: Following trastuzumab emtansine dosing, 5.1% (63/1243) of patients tested positive for anti-trastuzumab emtansine antibodies at one or more post-dose time points.
Maltese: Wara d-dożaġġ ta' trastuzumab emtansine, 5.1% (63/1,243) tal-pazjenti kellhom test pożittiv għallantikorpi kontra trastuzumab emtansine f'punt ta' żmien wieħed jew aktar wara d-doża.
English: Trastuzumab emtansine exposure (AUC) at Cycle 3 after repeated dosing in patients with mild or moderate hepatic dysfunction was within the range observed in patients with normal hepatic function.
Maltese: L-esponiment għal trastuzumab emtansine (AUC) f'Ċiklu 3 wara dożaġġ ripetut f'pazjenti b'disfunzjoni epatika ħafifa jew moderata kien fil-firxa osservata f'pazjenti b'funzjoni epatika normali.
English: In addition, trastuzumab emtansine, like trastuzumab, inhibits shedding of the HER2 ECD, inhibits signalling through the phosphatidylinositol 3-kinase (PI3-K) pathway, and mediates antibody-dependent cell-mediated cytotoxicity (ADCC) in human breast cancer cells that overexpress HER2.
Maltese: Barra dan, trastuzumab emtansine, bħal trastuzumab, jinibixxi r-reħa ta' HER2 ECD, jinibixxi s-sinjali permezz tar-rotta phosphatidylinositol 3-kinase (PI3-K), u jimmedja ċitotossiċità medjata miċ ċellula dipendenti mill-antikorpi (ADCC - antibody-dependent cell-mediated cytotoxicity)
English: After reconstitution one vial of 8 mL solution contains 20 mg/mL of trastuzumab emtansine (see section 6.6).
Maltese: Wara r-rikostituzzjoni kunjett wieħed ta' soluzzjoni ta' 8 mL ikun fih 20 mg/mL ta' trastuzumab emtansine (ara sezzjoni 6.6).
English: Trastuzumab emtansine (N=490) All Grades (%) Grade 3 (%) Grade 4 (%)
Maltese: Trastuzumab emtansine (N=490) Gradi kollha
English: Developmental toxicity of trastuzumab has been identified in the clinical setting although it was not predicted in the non-clinical program.
Maltese: Tossiċità fuq l-iżvilupp ta' trastuzumab kienet identifikata f'ambjent kliniku għalkemm ma kinitx imbassra fil-programm mhux klinku.
English: At retreatment a dose reduction may be considered according to the dose reduction schedule (see Table 1).
Maltese: Meta jerġa' jinbeda ttrattament jista' jiġi kkunsidrat tnaqqis fid-doża skont l-iskeda ta' tnaqqis fid-doża (ara Tabella 1).
English: For dose modifications for thrombocytopenia, see sections 4.2 and 4.4.
Maltese: Għall-modifikazzjonijiet fid-doża f'każ ta' reazzjonijiet relatati mal-infużjoni, ara sezzjonijiet 4.2 u 4.4.
English: Permanently discontinue trastuzumab emtansine
Maltese: Waqqaf trastuzumab emtansine b'mod permanenti
English: Injection site extravasation
Maltese: Infezzjonijiet u infestazzjonijiet
English: Hyperbilirubinemia TBILI
Maltese: ● diffikultà biex tiftakar
English: Symptomatic CHF Discontinue trastuzumab emtansine LVEF <40%
Maltese: Xi sintomi jistgħu jkunu sfurija tal-ġilda tiegħek u tal-abjad t'għajnejk (suffejra).
English: > 1.0 to ≤ 2.0´ the ULN
Maltese: TBILI > 1.0 sa ≤ 2.0 × l-ULN fil-jum tat-trattament skedat
English: How you are given Kadcyla
Maltese: Mediċini oħra u Kadcyla
English: You will be observed by a doctor or nurse while it is being given and for at least 30 minutes following the dose, in case you have any side effects.
Maltese: Inti se tiġi osservat minn tabib jew infermier waqt li tkun qed tingħata u għal mill-inqas 30 minuta wara l-ewwel doża, f'każ li jkollok xi effetti sekondarji.
English: PAES: In order to further investigate the efficacy of trastuzumab emtansine in the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy, the MAH should submit the final analysis of OS from the phase 3, randomised, open-label study KATHERINE (BO27938).
Maltese: Sabiex tiġi investigata aktar l-effikaċja ta' trastuzumab emtansine fittrattament awżiljarju ta' pazjenti adulti b'kanċer bikri tas-sider pożittiv għal HER2 li għandhom marda invażiva residwa, fis-sider u/jew fil-glandoli limfatiċi, wara terapija neoawżiljarja bbażata fuq taxane u mmirata lejn HER2, l-MAH għandu jissottometti l-analiżi finali ta' OS mill-istudju KATHERINE (BO27938)
English: Animal toxicology and/or pharmacology
Maltese: Tossikolġija u/jew farmakoloġija fl-annimali
English: Description of the key differences between trastuzumab emtansine and trastuzumab in relation to indication, dose, administration and packaging differences.
Maltese: Deskrizzjoni tad-differenzi ewlenin bejn trastuzumab emtansine u trastuzumab rigward differenzi fl-indikazzjoni, doża, għoti u ippakkjar.
English: Patients experiencing infusion-related reactions
Maltese: Reazzjonijiet relatati mal-infużjoni
English: · DM1 - an anti-cancer substance that becomes active once Kadcyla enters the cancer cell.
Maltese: • DM1 - sustanza kontra l-kanċer li ssir attiva ladarba Kadcyla jidħol fiċ-ċellula tal-kanċer.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Maltese: Punti Finali Sekondarji
English: Time to symptom progression, as defined by a 5-point decrease in the score derived from the Trials Outcome Index-Breast (TOI-B) subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life (FACT-B QoL) questionnaire was also assessed during the clinical study.
Maltese: Iż-żmien sal-progressjoni tas-sintomi, kif definit minn tnaqqis ta' 5 punti fil-punteġġ derivat millkwestjonarju tas-sottoskala tal-Indiċi tar-Riżultat mill-Provi-tas-Sider (TOI-B - Trials Outcome Index-Breast) tal-Valutazzjoni Funzjonali tal-Kwalità tal-Ħajja tat-Terapija tal-Kanċer-tas-Sider
English: DM1 was aneugenic or clastogenic in an in vivo single-dose rat bone marrow micronucleus assay at exposures that were comparable to mean maximum concentrations of DM1 measured in humans administered trastuzumab emtansine.
Maltese: DM1 kien anewġeniku jew klastoġeniku f'analiżi in vivo b'doża waħda f'mikronukleju tal-mudullun tal-firien f'esponimenti li kienu komparabbli mal-konċentrazzjonijiet massimi medji ta' DM1 imkejla fil-bnedmin li ngħataw trastuzumab emtansine.
English: Treatment must be permanently discontinued in the event of a life threatening infusionrelated reaction (see section 4.2).
Maltese: It-trattament għandu titwaqqaf b'mod permanenti f'każ ta' reazzjoni relatata mal-infużjoni ta' periklu għall-ħajja (ara sezzjoni 4.2).
English: Trastuzumab emtansine when administered intravenously every 3 weeks exhibited linear PK across doses ranging from 2.4 to 4.8 mg/kg; patients who received doses less than or equal to 1.2 mg/kg had faster clearance.
Maltese: Trastuzumab emtansine meta jingħata fil-vini kull 3 ġimgħat wera PK lineari tul dożi b'firxa minn 2.4 sa 4.8 mg/kg; pazjenti li rċevew dożi inqas minn jew ugwali għal 1.2 mg/kg kellhom tneħħija aktar malajr.
English: Discontinue trastuzumab emtansine if not resolving with standard treatment
Maltese: Waqqaf trastuzumab emtansine jekk ma tgħaddix bi trattament standard
English: Nervous system disorders Neuropathy peripheral, Headache
Maltese: Disturbi fis-sistema nervuża Newropatija periferali, Uġigħ ta' ras
English: Reactions secondary to extravasation have been observed in clinical studies with trastuzumab emtansine.
Maltese: Reazzjonijiet sekondarji għal ekstravażazzjoni kienu osservati fi studji kliniċi b'trastuzumab emtansine.
English: You will be observed by a doctor or nurse while it is being given and for at least 90 minutes following the initial dose, in case you have any side effects.
Maltese: Inti se tiġi osservat minn tabib jew infermier waqt li tkun qed tingħata u għal mill-inqas 90 minuta wara l-ewwel doża, f'każ li jkollok xi effetti sekondarji.
English: Your doctor will monitor you for signs and symptoms of neurological problems.
Maltese: It-tabib tiegħek se jissorveljak għal sinjali u sintomi ta' problemi newroloġiċi.
English: NAME OF THE MEDICINAL PRODUCT Kadcyla 160 mg powder for concentrate for solution for infusion trastuzumab emtansine
Maltese: Kadcyla 160 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: Patients who discontinued trastuzumab emtansine could complete the duration of their intended study treatment up to 14 cycles of HER2-directed therapy with trastuzumab if appropriate based on toxicity considerations and investigator discretion.
Maltese: Ilpazjenti li waqqfu trastuzumab emtansine setgħu jkomplu t-tul tat-trattament tal-istudju maħsub tagħhom sa 14-il ċiklu ta' terapija mmirata lejn HER2 bi trastuzumab jekk kien xieraq abbażi ta' kunsiderazzjonijiet tat-tossiċità u d-diskrezzjoni tal-investigatur.
English: In vitro metabolism studies in human liver microsomes suggest that DM1, a small molecule component of trastuzumab emtansine, is metabolised mainly by CYP3A4 and to a lesser extent by CYP3A5.
Maltese: DM1, komponent ta' molekula żgħira ta' trastuzumab emtansine, fil-biċċa l-kbira huwa metabolizzat minn CYP3A4 u fi kwantità inqas minn CYP3A5.
English: peripheral neuropathy until resolution to ≤ Grade 2.
Maltese: Il-maġġoranza tal-ADRs irrappurtati kellhom severità ta' Grad 1 jew 2.
English: IDFS was defined as the time from the date of randomization to first occurrence of ipsilateral invasive breast tumor recurrence, ipsilateral local or regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, or death from any cause.
Maltese: IDFS kienet iddefinita bħala ż-żmien mid-data ta' randomisation salewwel okkorrenza ta' rikorrenza tat-tumur tas-sider invażiv ipsilaterali, rikorrenza ta' kanċer tas-sider invażiv lokali jew reġjonali ipsilaterali, rikorrenza distanti, kanċer tas-sider invażiv kontralaterali, jew mewt minn kwalunkwe kawża.
English: 2,% [95% CI] Disease-Free Survival (DFS)3 Number (%) of patients with event HR [95% CI] p-value (Log-Rank test, unstratified) 3 year event-free rate2,% [95% CI] Distant recurrence-free interval (DRFI) Number (%) of patients with event HR [95% CI] p-value (Log-Rank test, unstratified) 3 year event-free rate
Maltese: Valur p (Test log-rank*) Punti finali sekondarji ewlenin PFS evalwata minn investigatur Numru (%) ta' pazjenti b'avveniment Tul medjan ta' PFS (xhur) Proporzjon ta' periklu (CI ta' 95%) Valur p (Test log-rank*) Rata ta' rispons oġġettiv (ORR) Pazjenti b'marda li tista' titkejjel Numru ta' pazjenti b'OR (%) Differenza (CI ta' 95%) Valur p (test Mantel-Haenszel chisquared*)
English: Trastuzumab was given intravenously at 6 mg/kg on Day 1 of a 21-day cycle.
Maltese: Trastuzumab ingħata fil-vini b'doża ta' 6 mg/kg fil-Jum 1 ta' ċiklu ta' 21 jum.
English: In vitro metabolism studies in human liver microsomes suggest that DM1, a component of trastuzumab emtansine, is metabolised mainly by CYP3A4 and, to a lesser extent, by CYP3A5.
Maltese: DM1, komponent ta' trastuzumab emtansine, fil-biċċa l-kbira huwa metabolizzat minn CYP3A4 u, fi kwanità inqas, minn CYP3A5.
English: Blood alkaline phosphatase increased, blood bilirubin increased
Maltese: Żieda fl-alkaline phosphatase fiddemm, żieda filbilirubin fid-demm
English: In KATHERINE, consistent treatment benefit of trastuzumab emtansine for IDFS was seen in all the pre-specified subgroups evaluated, supporting the overall result.
Maltese: F'KATHERINE, benefiċċju konsistenti tat-trattament ta' trastuzumab emtansine għal IDFS ġie osservat fis-sottogruppi speċifikati minn qabel kollha li ġew evalwati, u dan jappoġġa r-riżultat globali.
English: A Phase II, single-arm, open-label study evaluated the effects of trastuzumab emtansine in patients with HER2-positive incurable, LABC or MBC.
Maltese: II, bi grupp wieħed, open-label evalwa l-effetti ta' trastuzumab emtansine f'pazjenti b'LABC jew MBC pożittivi għal HER2 u li ma jistgħux jiġu kkurati.
English: Biotransformation (trastuzumab emtansine and DM1) Trastuzumab emtansine is expected to undergo deconjugation and catabolism by means of proteolysis in cellular lysosomes.
Maltese: Bijotrasformazzjoni (trastuzumab emtansine u DM1) Trastuzumab emtansine huwa mistenni li jgħaddi minn dekonjugazzjoni u kataboliżmu permezz ta' proteolisi fil-lisosomi ċellulari.
English: A randomised, multicentre, open-label phase II study evaluated the effects of trastuzumab emtansine versus trastuzumab plus docetaxel in patients with HER2-positive MBC who had not received prior chemotherapy for metastatic disease.
Maltese: II, randomised, b'aktar minn ċentru wieħed u open-label evalwa l-effetti ta' trastuzumab emtansine kontra trastuzumab flimkien ma' docetaxel f'pazjenti b'MBC pożittiv għal HER2 li ma kinux ħadu kimoterapija qabel għall-marda metastatika.
English: A. LABELLING
Maltese: ● indiġestjoni