FrancophonIA/ELRC3.0 huggingface dataset:
English: All candidates for treatment with Trazimera, but especially those with prior anthracycline and cyclophosphamide (AC) exposure, should undergo baseline cardiac assessment including history and physical examination, electrocardiogram (ECG), echocardiogram, and/or multigated acquisition (MUGA) scan or magnetic resonance imaging.
Maltese: Kull min jista' jingħata kura bi Trazimera, iżda b'mod speċjali dawk esposti minn qabel għal anthracycline u cyclophosphamide (AC), għandu jkollhom stima kardijaka bħala linja bażi inkluż passat mediku u eżami fiżiku, elettrokardjogramm (ECG - electrocardiogram), ekokardjogramm, u/jew skan multigated acquisition (MUGA) jew magnetic resonance imaging.
English: The results of these simulations indicate that at least 95% of patients will reach concentrations that are <1 μg/mL (approximately 3% of the population predicted Cmin,ss, or about 97% washout) by 7 months.
Maltese: Ir-riżultati ta' dawn is-simulazzjonijiet jindikaw li mill-inqas 95% tal-pazjenti se jilħqu konċentrazzjonijiet li huma <1 pg/mL (madwar 3% ta' Cmin,ss imbassra talpopolazzjoni, jew eliminazzjoni kompluta ta' madwar 97%) wara 7 xhur.
English: In the joint analysis of the NSABP B-31 and NCCTG N9831 studies, EBC was limited to women with operable breast cancer at high risk, defined as HER2-positive and axillary lymph node positive or HER2 positive and lymph node negative with high risk features (tumour size > 1 cm and ER negative or tumour size >2 cm, regardless of hormonal status).
Maltese: Fl-analiżi konģunta tal-istudji NSABP B-31 u NCCTG N9831, EBC kien limitat għal nisa b'kanċer operabbli tas-sider li kellhom riskju għoli, definit bħala pożittiv għal HER2 u pożittiv għall-glandoli limfatiċi ta' taħt l-abt jew pożittiv għal HER2 u negattiv għall-glandoli limfatiċi ta' taħt l-abt b'fatturi ta' riskju għoli (daqs tat-tumur ta' > 1 ċm u negattiv għal ER jew daqs tat-tumur ta' > 2 ċm, irrispettivament mill-istat tal-ormoni).
English: The hazard ratio translates into an absolute benefit, in terms of 3-year disease-free survival rate estimates of 11.8 percentage points (87.2% versus 75.4%) in favour of the AC→PH (trastuzumab) arm.
Maltese: Il-proporzjon ta' periklu jittraduċi f'benefiċċju assolut, f'termini ta' stimi ta' rata ta' sopravivenza mingħajr il-marda ta' 3 snin ta' 11.8 punti perċentwali (87.2 % kontra 75.4 %) favur il-grupp ta' AC→PH (trastuzumab).
English: - following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.
Maltese: wara kimoterapija awżiljarja b'doxorubicin u cyclophosphamide, flimkien ma' paclitaxel jew docetaxel.
English: In the final population PK model, in addition to primary tumour type, body-weight, serum aspartate aminotransferase and albumin were identified as a statistically significant covariates affecting the exposure of trastuzumab.
Maltese: Fil-mudell finali tal-PK tal-popolazzjoni, minbarra t-tip tat-tumur primarju, il-piż tal-ġisem, aspartate aminotransferase fis-serum u albumina kienu identifikati bħala kovarjabbli statistikament sinifikanti li jaffettwaw l-esponiment għal trastuzumab.
English: Total CL range from Cmax,ss to Cmin,ss (L/day)
Maltese: Firxa ta' CL totali minn Cmax,ss sa min,ss
English: Reversibility of mild symptomatic and asymptomatic left ventricular dysfunction was demonstrated for 79.5% of patients.
Maltese: Riversibilità ta' disfunzjoni ħafifa tal-ventrikolu tax-xellug bis-sintomi u bla sintomi intweriet għal 79.5 % tal-pazjenti.
English: Each 150 mg vial of Trazimera is reconstituted with 7.2 mL of sterile water for injections (not supplied).
Maltese: Kull kunjett ta' 150 mg ta' Trazimera huwa rikostitwit b'7.2 mL ta' ilma għall-injezzjoni sterili (mhux ipprovdut).
English: Patients who develop asymptomatic cardiac dysfunction may benefit from more frequent monitoring (e.g., every 6 - 8 weeks).
Maltese: Pazjenti li jiżviluppaw disfunzjoni kardijaka mhux sintomatika, jistgħu jibbenefikaw minn monitoraġġ aktar frekwenti (eż. kull 6 - 8 ġimgħat).
English: Muscle tightness
Maltese: Kunjett wieħed
English: In the BCIRG 006 study HER2 positive, EBC was defined as either lymph node positive or high risk node negative patients with no (pN0) lymph node involvement, and at least 1 of the following factors: tumour size greater than 2 cm, oestrogen receptor and progesterone receptor negative, histological and/or nuclear grade 2-3, or age <35 years).
Maltese: Fl-istudju BCIRG 006, EBC pożittiv għal HER2 kien definit bħala pożittiv għall-glandoli limfatiċi jew pazjenti negattivi għall-glandoli b'riskju għoli bl-ebda (pN0) involviment tal-glandoli limfatiċi, u mill- inqas wieħed mill-fatturi li ģejjin: daqs tat-tumur akbar minn 2 ċm, negattivi għar-riċetturi tal-estrogen u riċetturi tal-progesterone, grad istoloģiku u/jew nukleari ta' 2-3, jew età ta' < 35 sena).
English: Experience of concurrent administration of trastuzumab with low dose anthracycline regimens is currently limited to two trials (MO16432 and BO22227).
Maltese: Esperjenza ta' għoti fl-istess waqt ta' trastuzumab ma' korsijiet b'doża baxxa ta' antharacycline bħalissa hija limitata għal żewġ provi (MO16432 u BO22227).
English: Table 4 Efficacy Results from the Monotherapy and Combination Therapy Studies Parameter Monotherapy
Maltese: Tabella 4: Riżultati tal-Effikaċja mill-Istudji ta' Monoterapija u ta' Terapija Kombinata
English: • 150 mg trastuzumab that has to be dissolved in 7.2 mL of sterile water for injections, or
Maltese: • 150 mg trastuzumab li għandu jiġi mdewweb f'7.2 mL ta' ilma sterili għall-injezzjonijiet, jew
English: Volume (mL) = Body weight (kg) x dose (4 mg/kg for loading or 2 mg/kg for maintenance) 21 (mg/mL, concentration of reconstituted solution)
Maltese: Volum (mL) = Piż tal-gisem (kg) x doża (4 mg/kg għad-doża ogħla tal-bidu jew 2 mg/kg għad-doża ta' manteniment) 21 (mg/mL, konċentrazzjoni ta' soluzzjoni rikostitwita)
English: Pharmacokinetic data from Study H4613g/GO01305 in patients with metastatic or locally advanced inoperable HER2-positive cancer suggested that trastuzumab had no impact on the PK of carboplatin.
Maltese: Dejta farmakokinetika minn Studju H4613g/GO01305 f'pazjenti b'kanċer metastatiku jew avanzat lokalment pożittiv għal HER2 li ma jistax jiġi operat issuġġeriet li trastuzumab ma kellu l-ebda impatt fuq il-PK ta' carboplatin.
English: No incompatibilities between Trazimera and polyvinylchloride, polyethylene, polypropylene or ethylene vinyl acetate bags or with glass intravenous bottles have been observed.
Maltese: Ma kinux osservati inkompatibilitajiet bejn Trazimera u boroż tal-polyvinylchloride, polyethylene, polypropylene jew ethylene vinyl acetate jew bi fliexken tal-ħġieġ għal użu ġol-vini.
English: There was a correlation between shed antigen and SGOT/AST levels; part of the impact of shed antigen on clearance may have been explained by SGOT/AST levels.
Maltese: SGOT/AST; parti millimpatt ta' shed antigen fuq it-tneħħija jista' jkun spjegat minn livelli ta' SGOT/AST.
English: In addition, terms reported in the post marketing setting are included in Table 1.
Maltese: Barra minn hekk, termini rapportati fl-ambjent ta' wara t-tqegħid fis-suq huma inklużi f'Tabella 1.
English: For the primary endpoint, DFS, the addition of trastuzumab to paclitaxel chemotherapy resulted in a 52% decrease in the risk of disease recurrence.
Maltese: Għall-punt finali primarju, DFS, iż-żieda ta' trastuzumab ma' kimoterapija b'paclitaxel irriżultat fi tnaqqis ta' 52 % fir-riskju ta' rikorrenza tal-marda.
English: • Doxorubicin 60 mg/m 2 and paclitaxel 150 mg/m 2, administered 3-weekly for 3 cycles,
Maltese: • Doxorubicin 60 mg/m2 u paclitaxel 150 mg/m2, mogħtija darba kull 3 ġimgħat għal 3 ċikli, li kien segwit minn • Paclitaxel 175 mg/m2 mogħti darba kull 3 ġimgħat għal 4 ċikli, li kien segwit minn
English: and 7.1% to 42.6% for FISH.
Maltese: Rata ta' Rispons Globali, % 34.5 % 47.
English: The appropriate amount of solution should be withdrawn from the vial and added to a polyvinylchloride, polyethylene, polypropylene or ethylene vinyl acetate infusion bag, or a glass infusion bottle containing 250 mL of sodium chloride 9 mg/mL (0.9%) solution.
Maltese: L-ammont xieraq ta' soluzzjoni għandu jittella' mill-kunjett u jiżdied ma' borża tal-infużjoni magħmula minn polyvinylchloride, polyethylene, polypropylene jew ethylene vinyl acetate, jew flixkun tal-ħġieġ għall-infużjoni li jkun fih 250 mL ta' sodium chloride 9 mg/mL (0.9 %).
English: Malignant neoplasm progression
Maltese: Progressjoni ta' neoplażma malinna
English: Patients with MBC who have previously received anthracyclines are also at risk of cardiac dysfunction with Trazimera treatment, although the risk is lower than with concurrent use of Trazimera and anthracyclines.
Maltese: Pazjenti b'MBC li qabel kienu rċevew anthracyclines ukoll huma f'riskju ta' disfunzjoni kardijaka b'kura bi Trazimera, għalkemm ir-riskju huwa inqas milli bl-użu fl-istess waqt ta' Trazimera u anthracyclines.
English: This yields a 20.6 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.0.
Maltese: Dan jagħti 20.6 mL ta' soluzzjoni għall-użu ta' darba, li fiha madwar 21 mg/mL ta' trastuzumab, b'pH ta' madwar 6.0.
English: Trazimera is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer: (MBC):
Maltese: Trazimera huwa indikat għall-kura ta' pazjenti adulti b'kanċer metastatiku tas-sider (MBC - metastatic breast cancer) pożittiv għal HER2:
English: Death (OS event) No. patients with event p=0.0024
Maltese: Mewt (avveniment OS): Numru ta' pazjenti blavveniment p=0.0024
English: Long term follow-up efficacy analysis DFS Hazard rations (95% CI) p-value p<0.0001
Maltese: Proporzjonijiet ta' periklu talanaliżi ta' Segwitu fit-tul tal- effikaċja ta' DFS (CI ta' 95 %) valur p p<0.0001
English: One vial contains 150 mg trastuzumab.
Maltese: Kunjett wieħed fih 150 mg trastuzumab.
English: Comparison of trastuzumab PK data from Study M77004 in which women with HER2-positive MBC were treated concomitantly with trastuzumab, paclitaxel and doxorubicin to trastuzumab PK data in studies where trastuzumab was administered as monotherapy (H0649g) or in combination with anthracycline plus cyclophosphamide or paclitaxel (Study H0648g), suggested no effect of doxorubicin and paclitaxel on the pharmacokinetics of trastuzumab.
Maltese: Paragun ta' dejta PK dwar trastuzumab minn Studju M77004 fejn nisa b'MBC pożittiv għal HER2 kienu kkurati bi trastuzumab, paclitaxel u doxorubicin fl-istess waqt ma' dejta PK dwar trastuzumab fi studji fejn trastuzumab ingħata bħala monoterapija (H0649g) jew flimkien ma' anthracycline u cyclophosphamide jew paclitaxel (Studju H0648g), ma jissuġġerixxi lebda effett ta' doxorubicin u paclitaxel fuq il-farmakokinetika ta' trastuzumab.
English: Study JP19959 was a substudy of BO18255 (ToGA) performed in male and female Japanese patients with advanced gastric cancer to study the pharmacokinetics of capecitabine and cisplatin when used with or without trastuzumab.
Maltese: Studju JP19959 kien sottostudju ta' BO18255 (ToGA) li twettaq fuq pazjenti rġiel u nisa Ġappuniżi b'kanċer avanzat tal-istonku biex jistudja l-farmakokinetika ta' capecitabine u cisplatin meta jintużaw ma' jew mingħajr trastuzumab.
English: Weak to moderate complete, basolateral or lateral membranous reactivity in ≥10% of tumour cells
Maltese: Reattività ħafifa sa moderata, kompluta, bażolaterali jew laterali fil-membrana f'≥ 10 % taċ-ċelluli tat-tumur
English: A: doxorubicin; C: cyclophosphamide; P: paclitaxel; H: trastuzumab At median duration of follow up of 1.8 years for the patients in the AC→P arm and 2.0 years for patients in the AC→PH arm p value for OS did not cross the pre-specified statistical boundary for comparison of AC→PH vs. AC→P
Maltese: A: doxorubicin; C: cyclophosphamide; P: paclitaxel; H: trastuzumab * F'tul ta' żmien medjan ta' segwitu ta' 1.8 snin għall-pazjenti fil-grupp ta' AC→P u sentejn għall-pazjenti filgrupp ta' AC→PH ** Valur p għal OS ma qabisx il-limitu statistiku speċifikat minn qabel għall-paragun ta' AC→PH kontra AC→P
English: Neoplasm progression
Maltese: Mhux magħruf Progressjoni ta' neoplażma
English: AC→D = doxorubicin plus cyclophosphamide, followed by docetaxel; AC→DH = doxorubicin plus cyclophosphamide, followed by docetaxel plus trastuzumab; CI = confidence interval
Maltese: AC→D = doxorubicin flimkien ma' cyclophosphamide, segwit minn docetaxel; AC→DH = doxorubicin flimkien ma' cyclophosphamide, segwit minn docetaxel flimkien ma' trastuzumab; CI = intervall ta' kunfidenza
English: - Study BO16348 was designed to compare one and two years of three-weekly trastuzumab treatment versus observation in patients with HER2 positive EBC following surgery, established chemotherapy and radiotherapy (if applicable).
Maltese: - Studju BO16348 kien maħsub biex iqqabbel kura bi trastuzumab kull tliet ġimgħat għal sena u sentejn ma' osservazzjonijiet f'pazjenti b'EBC pożittiv għal HER2 wara kirurġija, kimoterapija stabbilita u radjuterapija (jekk applikabbli).
English: Volume (mL) = Body weight (kg) x dose (8 mg/kg for loading or 6 mg/kg for maintenance) 21 (mg/mL, concentration of reconstituted solution)
Maltese: Volum (mL) = Piż tal-gisem (kg) x doża (8 mg/kg għad-doża ogħla tal-bidu jew 6 mg/kg għad-doża ta' manteniment) 21 (mg/mL, konċentrazzjoni tas-soluzzjoni rikostitwita)
English: There is no relevant use of Trazimera in the paediatric population.
Maltese: M'hemm l-ebda użu rilevanti ta' Trazimera fil-popolazzjoni pedjatrika.
English: Patients who had previously received anthracycline-based adjuvant chemotherapy were treated with paclitaxel (175 mg/m2 infused over 3 hours) with or without trastuzumab.
Maltese: Pazjenti li qabel kienu rċevew kimoterapija awżiljarja bbażata fuq anthracycline kienu kkurati b'paclitaxel (175 mg/m2 mogħti bħala infużjoni fuq medda ta' 3 sigħat) bi jew mingħajr trastuzumab.
English: This yields a 7.4 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.0.
Maltese: Dan jagħti 7.4 mL ta' soluzzjoni għall-użu ta' darba, li fiha madwar 21 mg/mL ta' trastuzumab, b'pH ta' madwar 6.0.
English: Solutions of Trazimera for intravenous infusion are physically and chemically stable in polyvinylchloride, polyethylene, polypropylene or ethylene vinyl acetate bags, or glass intravenous bottles, containing sodium chloride 9 mg/mL (0.9%) solution for injection for 24 hours at temperatures not exceeding 30°C.
Maltese: Soluzzjonijiet ta' Trazimera għall-infużjoni fil-vini huma fiżikament u kimikament stabbli għal 24 siegħa f'temperaturi li ma jaqbżux 30°C, f'boroż tal-polyvinylchloride, polyethylene, polypropylene jew ethylene vinyl acetate, jew fliexken tal-ħġieġ għal ġol-vini, li fihom soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9 %) sodium chloride.
English: Death (OS event): No. patients with event p=0.014
Maltese: Mewt (avveniment OS): Numru ta' pazjenti blavveniment p=0.014
English: If possible, physicians should avoid anthracycline-based therapy for up to 7 months after stopping trastuzumab.
Maltese: Jekk possibbli, it-tobba għandhom jevitaw terapija bbażata fuq anthracycline għal sa 7 xhur wara lwaqfien ta' trastuzumab.
English: AC→DH (n=1074)
Maltese: AC→DI1 (n=1074)
English: Doxorubicin and cyclophosphamide were administered concurrently as follows:
Maltese: Doxorubicin u cyclophosphamide ingħataw flimkien kif ġej:
English: An absolute benefit of 13 percentage points in favour of the trastuzumab arm was estimated in terms of 3-year event-free survival rate (65% versus 52%).
Maltese: Benefiċċju assolut ta' 13-il punt perċentwali favur il-grupp ta' trastuzumab kien stmat f'termini ta' rata ta' sopravivenza mingħajr avveniment ta' 3 snin (65 % kontra 52 %).
English: Distant recurrence No. patients with event p=0.0008
Maltese: Numru ta' pazjenti blavveniment p=0.0008
English: Hypoprothrombinaemia
Maltese: Tromboċitopenija
English: - cisplatin - 80 mg/m 2 every 3 weeks for 6 cycles on day 1 of each cycle.
Maltese: cisplatin - 80 mg/m 2 kull 3 ġimgħat għal 6 ċikli fl -ewwel ġurnata ta' kull ċiklu.
English: The frequency of progression in the liver was significantly reduced in patients treated with the combination of trastuzumab and paclitaxel, compared to paclitaxel alone (21.8% versus 45.7%;
Maltese: Il-frekwenza ta' progressjoni fil-fwied kienet imnaqqsa b'mod sinifikanti fil-pazjenti kkurati bilkombinazzjoni ta' trastuzumabu paclitaxel, meta mqabbel ma' paclitaxel waħdu (21.8 % kontra 45.7 %, p = 0.004).
English: Trazimera 420 mg powder for concentrate for solution for infusion trastuzumab
Maltese: Trazimera 420 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: Pleural effusion
Maltese: Kura awżiljarja
English: The presence of anti-trastuzumab antibodies had no impact on the pharmacokinetics, efficacy (determined by pathological Complete Response [pCR] and event free survival [EFS]) and safety determined by occurrence of administration related reactions (ARRs) of trastuzumab intravenous.
Maltese: Il-preżenza ta' antikorpi kontra trastuzumab ma kellha l-ebda impatt fuq il-farmakokinetika, l-effikaċja (determinata mir-Rispons Komplut patoloġiku [pCR - pathological Complete Response]) u s-sopravivenza mingħajr avveniment [EFSevent free survival] u s-sigurtà determinati mill-okkorrenza ta' reazzjonijiet relatati mal-għoti (ARRsadministration related reactions) ta' trastuzumab fil-vini.
English: Other medicines and Trazimera
Maltese: Mediċini oħra u Trazimera
English: Lung infiltration
Maltese: Infiltrati fil-pulmun
English: Patients who receive anthracyclines after stopping trastuzumab may possibly be at increased risk of cardiac dysfunction.
Maltese: Pazjenti li jirċievu anthracyclines wara l-waqfien ta' trastuzumab jistgħu jkunu f'riskju akbar ta' disfunzjoni kardijaka.
English: Trastuzumab plus paclitaxel
Maltese: 'Reazzjoni anafilattika
English: After reconstitution with sterile water for injections the reconstituted solution is physically and chemically stable for 48 hours at 2°C - 8°C.
Maltese: Wara r-rikostituzzjoni b'ilma għall-injezzjonijiet sterili s-soluzzjoni rikostitwita hija fiżikament u kimikament stabbli għal 48 siegħa f'temperatura ta' 2°C - 8°C.
English: By comparison of simulated serum trastuzumab concentrations after trastuzumab monotherapy (4 mg/kg loading/2 mg/kg q1w intravenous) and observed serum concentrations in Japanese women with HER2- positive MBC (study JP16003) no evidence of a PK effect of concurrent administration of docetaxel on the pharmacokinetics of trastuzumab was found.
Maltese: Permezz ta' paragun ta' konċentrazzjonijiet simulati ta' trastuzumab fis-serum wara monoterapija ta' trastuzumab (doża għolja tal-bidu ta' 4 mg/kg/2 mg/kg q1w ġol-vini) u konċentrazzjonijiet osservati fis-serum f'nisa Ġappuniżi b'MBC pożittiv għal HER2 (studju JP16003) ma nstabet l-ebda evidenza ta' effett PK tal-għoti fl-istess waqt ta' docetaxel fuq il-farmakokinetika ta' trastuzumab.
English: Data from study JP16003, a single-arm study of trastuzumab (4 mg/kg intravenous loading dose and 2 mg/kg intravenous dose weekly) and docetaxel (60 mg/m2 intravenous dose) in Japanese women with HER2- positive MBC, suggested that concomitant administration of trastuzumab had no effect on the single-dose pharmacokinetics of docetaxel.
Maltese: Dejta minn studju JP16003, studju bi grupp wieħed ta' trastuzumab (doża għolja tal-bidu ta' 4 mg/kg ġol-vini u 2 mg/kg ġol-vini kull ġimgħa) u docetaxel (60 mg/m2 ġol-vini) f'nisa Ġappuniżi b'MBC pożittiv għal HER2, issuġġeriet li l-għoti fl-istess waqt ta' trastuzumab ma kellu l-ebda effett fuq ilfarmakokinetika ta' doża waħda ta' docetaxel.
English: Table 11 Post-Hoc Exploratory Analysis Results from the Joint Analysis NSABP B-31/NCCTG N9831* and BCIRG006 Clinical Studies Combining DFS Events and Symptomatic Cardiac Events AC→PH (vs. AC→P) (NSABP B-31 and NCCTG N9831)
Maltese: Barra dan saret analiżi esploratorja post-hoc fuq is-settijiet ta' dejta mill-analiżi konġunta (JAjoint analysis) tal-istudji kliniċi NSABP B-31/NCCTG N9831
English: In the adjuvant treatment setting, trastuzumab was investigated in 4 large multicentre, randomised, trials.
Maltese: Flambjent ta' trattament awżiljarju, trastuzumab kien investigat f'4 provi kbar, b'aktar minn ċentru wieħed u randomised:
English: Table 1 Undesirable Effects Reported with Intravenous trastuzumab Monotherapy or in Combination with Chemotherapy in Pivotal Clinical Trials (N=8386) and in Post-Marketing
Maltese: Tabella 1 Effetti Mhux Mixtieqa Rrappurtati bi trastuzumab fil-Vini bħala Monoterapija jew Flimkien ma' Kimoterapija fi Provi Kliniċi Pivitali (N = 8386) u Wara t-Tqegħid fis-Suq
English: Tabulated list of adverse reactions
Maltese: Lista ta' reazzjonijiet avversi f tabella
English: Table 7 Summary of Efficacy results from the joint analysis of the NSABP B-31 and NCCTG N9831 trials at the time of the definitive DFS analysis
Maltese: Sommarju ta' riżultati tal-Effikaċja mill-analiżi konġunta tal-provi NSABP B-31 u NCCTG N9831 fil-ħin tal-analiżi definittiva ta' DFS
English: Comparison of PK results from two Phase II studies (BO15935 and M77004) and one Phase III study (H0648g) in which patients were treated concomitantly with trastuzumab and paclitaxel and two Phase II studies in which trastuzumab was administered as monotherapy (W016229 and MO16982), in women with HER2-positive MBC indicates that individual and mean trastuzumab trough serum concentrations varied within and across studies but there was no clear effect of the concomitant administration of paclitaxel on the pharmacokinetics of trastuzumab.
Maltese: II li fihom trastuzumab ingħata bħala monoterapija (W016229 u MO16982), f'nisa b'MBC pożittiv għal HER2 jindika li l-inqas konċentrazzjonijiet individwali u medji fis-serum ta' trastuzumab varjaw fi ħdan u bejn l-istudji iżda ma kien hemm l-ebda effett ċar tal-għoti flimkien ta' paclitaxel fuq ilfarmakokinetika ta' trastuzumab.
English: At 8 years, the survival rate was estimated to be 86.9% in the AC→PH arm and 79.4% in the AC→P arm, an absolute benefit of 7.4% (95% CI 4.9%, 10.0%).
Maltese: Wara 8 snin, ir-rata ta' sopravivenza kienet stmata bħala 86.9% fil-grupp ta' AC'→PH u 79.4% fil-grupp ta' AC'→P. benefiċċju assolut ta' 7.4% (CI ta' 95% 4.9%, 10.
English: The appropriate amount of solution should be withdrawn from the vial and added to an infusion bag or bottle containing 250 mL of sodium chloride 9 mg/mL (0.9%) solution.
Maltese: Il-ammont xieraq ta' soluzzjoni għandu jittella' mill-kunjett u jiżdied ma' borża tal-infużjoni jew flixkun li fiha 250 mL ta' soluzzjoni ta' Sodium chloride 9 mg/mL (0.9 %).
English: Unopened vial can be stored up to 30ºC for a single period of up to 3 months.
Maltese: Kunjett mhux miftuħ jista' jinħażen sa 30°C għal perjodu wieħed sa 3 xhur.
English: The primary endpoint was overall survival which was defined as the time from the date of randomization to the date of death from any cause.
Maltese: Il-punt finali primarju kien issopravivenza globali li kienet definita bħala ż-żmien mid-data ta' randomization sad-data tal-mewt minn kwalunkwe kawża.
English: Neoadjuvant-adjuvant treatment
Maltese: IL-PRODOTT MEDIĊINALI
English: • itchiness
Maltese: • stitikezza
English: In the neoadjuvant-adjuvant treatment setting, study MO16432, a multicentre randomised trial, was designed to investigate the clinical efficacy of concurrent administration of trastuzumab with neoadjuvant chemotherapy including both an anthracycline and a taxane, followed by adjuvant trastuzumab, up to a total treatment duration of 1 year.
Maltese: F'ambjent ta' trattament neoawżiljarju-awżiljarju, l-istudju MO16432, prova randomized b'aktar minn ċentru wieħed, kienet maħsuba biex tinvestiga l-effikaċja klinika ta' għoti ta' trastuzumab flimkien ma' kimoterapija neoawżiljarja inkluż kemm anthracycline kif ukoll taxane, segwit minn trastuzumab awżiljarju, sa tul ta' kura totali ta' sena.