FrancophonIA/ELRC3.0 huggingface dataset:
English: *Co-primary endpoint of DFS of 1 year versus observation met the pre-defined statistical boundary **Final analysis (including cross-over of 52% of patients from the observation arm to trastuzumab) ***There is a discrepancy in the overall sample size due to a small number of patients who were randomised after the cut-off date for the 12-month median follow-up analysis
Maltese: *Riżultat finali ko-primarju ta' DFS ta' sena waħda kontra osservazzjoni laħaq il-konfin statistiku definit minn qabel **Analiżi finali (inkluż crossover ta' 52% tal-pazjenti mill-grupp ta' osservazzjoni għal trastuzumab) ***Hemm diskrepanza fid-daqs tal-kampjun globali minħabba n-numru żgħir ta' pazjenti li kienu randomised wara d-data cut-off għall-analiżi ta' segwitu medjan ta' 12-il xahar
English: Dyspepsia
Maltese: Dispepsja
English: +Respiratory failure
Maltese: +Insuffiċjenza respiratorja
English: 150 mg vial
Maltese: Kunjett ta' 150 mg
English: Table 8 Final overall survival analysis from the joint analysis of trials NSABP B-31 and NCCTG N9831
Maltese: Analiżi finali tas-sopravivenza globali mill-analiżi konġunta tal-provi NSABP B-31 u NCCTG N9831
English: Each 150 mg vial of KANJINTI is reconstituted with 7.2 mL of sterile water for injections (not supplied).
Maltese: Kull kunjett ta' KANJINTI 150 mg huwa rikostitwit b'7.2 mL ta' ilma għall-injezzjoni sterili (mhux ipprovdut).
English: There is no fertility data available.
Maltese: M'hemmx data disponibbli dwar il-fertilità.
English: In the BCIRG 006 study for the primary endpoint, DFS, the hazard ratio translates into an absolute benefit, in terms of 3-year disease-free survival rate estimates of 5.8 percentage points (86.7% versus 80.9%) in favour of the AC→DH (trastuzumab) arm and 4.6 percentage points (85.5% versus 80.9%) in favour of the DCarbH (trastuzumab) arm compared to AC→D.
Maltese: Fl-istudju BCIRG 006 għall-punt finali primarju, DFS, il-proporzjon ta' periklu jittraduċi f'benefiċċju assolut, f'termini ta' stimi ta' rata ta' sopravivenza mingħajr il-marda ta' 3 snin ta' 5.8 punti perċentwali (86.7% kontra 80.9%) favur il-grupp AC→DH (trastuzumab) u 4.6 punti perċentwali (85.
English: which was followed by - Paclitaxel 175 mg/m2 administered 3-weekly for 4 cycles,
Maltese: li kien segwit minn - Paclitaxel 175 mg/m2 mogħti darba kull 3 ġimgħat għal 4 ċikli,
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-ġisem (kg) x doża (8 mg/kg għad-doża ogħla tal-bidu jew 6 mg/kg għad-doża ta' manteniment)
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)
English: This investigative clinical trial assay performed in a central laboratory utilised a 0 to 3+ scale.
Maltese: Dan l-analiżi investigattiv tal-prova klinika li twettaqf'laboratorju ċentrali għamel użu minn skala ta' 0 sa 3+.
English: In 3 pivotal clinical trials of adjuvant trastuzumab given in combination with chemotherapy, the incidence of grade 3/4 cardiac dysfunction (specifically symptomatic congestive heart failure) was similar in patients who were administered chemotherapy alone (i.e. did not receive trastuzumab) and in patients who were administered trastuzumab sequentially to a taxane (0.3-0.4%).
Maltese: Fi 3 provi kliniċi pivitali b'trastuzumab mogħti b'mod awżiljarju flimkien ma' kimoterapija, linċidenza ta' disfunzjoni kardijaka ta' grad 3/4 (b'mod speċifiku insuffiċjenza konġestiva tal-qalb sintomatika) kienet simili f'pazjenti li ngħataw kimoterapija waħedha (jiġifieri ma rċevewx trastuzumab) u f'pazjenti li ngħataw trastuzumab b'mod sekwenzjali wara taxane (0.3-0.4%).
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: 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: Pulmonary hypoplasia
Maltese: Ipoplasija pulmonari
English: • heartburn (dyspepsia)
Maltese: • diffikultà biex torqod (insomnija)
English: Serious IRRs to trastuzumab infusion including dyspnoea, hypotension, wheezing, hypertension, bronchospasm, supraventricular tachyarrhythmia, reduced oxygen saturation, anaphylaxis, respiratory distress, urticaria and angioedema have been reported (see section 4.8).
Maltese: Kienu rrappurtati IRRs serji għall-infużjoni ta' trastuzumab inkluż qtugħ ta' nifs, pressjoni baxxa, tħarħir, pressjoni għolja, bronkospażmu, taki-arritmija supraventrikulari, saturazzjoni ta' ossiġnu mnaqqsa, anafilassi, distress respiratorju, urtikarja u anġjoedima (ara sezzjoni 4.8).
English: AC→D = doxorubicin plus cyclophosphamide, followed by docetaxel; DCarbH = docetaxel, carboplatin and trastuzumab; CI = confidence interval
Maltese: AC→D = doxorubicin flimkien ma' cyclophosphamide, segwit minn docetaxel; DCarbH = docetaxel, carboplatin u trastuzumab; CI = intervall ta' kunfidenza
English: In addition, cases of interstitial lung disease including lung infiltrates, acute respiratory distress syndrome, pneumonia, pneumonitis, pleural effusion, respiratory distress, acute pulmonary oedema and respiratory insufficiency have been reported.
Maltese: Barra dan kienu rrappurtati każijiet ta' mard tal-interstizju tal-pulmun inkluż infiltrati fil-pulmun, sindrome ta' distress respiratorju akut, pnewmonja, pulmonite, effużjoni fil-plewra, distress respiratorju, edima pulmonari akuta, u insuffiċjenza respiratorja.
English: Risk factors for a cardiac event identified in four large adjuvant studies included advanced age (> 50 years), low LVEF (< 55%) at baseline, prior to or following the initiation of paclitaxel treatment, decline in LVEF by 10-15 points, and prior or concurrent use of anti-hypertensive medicinal products.
Maltese: Fatturi ta' riskju għall-avveniment kardijaku identifikati f'erba' studji awżiljari kbar inkludew età avvanzata (> 50 sena), LVEF ta' livell baxx (< 55%) fil-linja bażi, qabel jew wara l-bidu tat-trattament b'paclitaxel, tnaqqis ta' LVEF b'10-15-il punt, u użu minn qabel jew fl-istess waqt ta' prodotti mediċinali kontra l-pressjoni għolja.
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: p < 0.0001 p = 0.014**
Maltese: p = 0.014**
English: - intravenous cyclophosphamide, at 600 mg/m2 over 30 minutes, given every 3 weeks for
Maltese: - cyclophosphamide fil-vini, b'doża ta' 600 mg/m2 fuq medda ta' 30 minuta, mogħti kull 3 ġimgħat għal 4 ċikli.
English: Patients with MBC who have previously received anthracyclines are also at risk of cardiac dysfunction with KANJINTI treatment, although the risk is lower than with concurrent use of KANJINTI and anthracyclines.
Maltese: Pazjenti b'MBC li qabel kienu rċevew anthracyclines ukoll huma f'riskju ta' disfunzjoni kardijaka bi trattament b'KANJINTI, għalkemm ir-riskju huwa inqas milli bl-użu fl-istess waqt ta' KANJINTI u anthracyclines.
English: The risk of neutropenia may be slightly increased when trastuzumab is administered with docetaxel following anthracycline therapy.
Maltese: Ir-riskju ta' newtropenija jista' jiżdied xi ftit meta trastuzumab jingħata flimkien ma' docetaxel wara terapija b'anthracycline.
English: It is not known whether trastuzumab can affect reproductive capacity.
Maltese: Mhuwiex magħruf jekk trastuzumab jistax jeffettwa l-kapaċità riproduttiva.
English: Other medicines and KANJINTI
Maltese: Mediċini oħra u KANJINTI
English: At 8 years, the disease-free survival rate was estimated to be 77.2% (95% CI: 75.4, 79.1) in the AC→PH arm, an absolute benefit of 11.8% compared with the AC→P arm.
Maltese: Wara 8 snin, ir-rata ta' sopravivenza mingħajr marda kienet stmata bħala 77.2% (CI ta' 95%: 75.4, 79.1) fil-grupp ta' AC→PH, benefiċċju assolut ta' 11.8% meta mqabbel mal-grupp ta' AC→P.
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: 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: Data farmakokinetika minn Studju H4613g/GO01305 f'pazjenti b'kanċer metastatiku jew avvanzat lokalment pożittiv għal HER2 li ma jistax jiġi operat issuġġeriet li trastuzumab ma kellu l-ebda impatt fuq il-PK ta' carboplatin.
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 mill-impatt ta' shed antigen fuq it-tneħħija jista' jkun spjegat minn livelli ta' SGOT/AST.
English: • Tumour lysis syndrome (a group of metabolic complications occurring after cancer treatment characterised by high blood levels of potassium and phosphate, and low blood levels of calcium).
Maltese: • Sindrome ta' lisi tat-tumur (sett ta' komplikazzjonijiet metaboliċi li jseħħu wara trattament kontra l-kanċer ikkaratterizzati minn livelli għolja ta' potassium u phosphate fid-demm, u livelli baxxi ta' calcium fid-demm).
English: • Hypersensitivity to trastuzumab, murine proteins, or to any of the excipients listed in section 6.1
Maltese: • Sensittività eċċessiva għal trastuzumab, proteini tal-ġrieden, jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
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: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1281/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1281/002
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: Administration in combination with paclitaxel or docetaxel In the pivotal trials (H0648g, M77001), paclitaxel or docetaxel was administered the day following the first dose of trastuzumab (for dose, see the Summary of Product Characteristics (SmPC) for paclitaxel or docetaxel) and immediately after the subsequent doses of trastuzumab if the preceding dose of trastuzumab was well tolerated.
Maltese: Fil-provi pivitali (H0648g, M77001), paclitaxel jew docetaxel ingħata l-għada tal-ewwel doża ta' trastuzumab (għad-doża, ara s-Sommarju tal-Karatteristiċi tal-Prodott (SmPC - Summary of Product Characteristics) għal paclitaxel jew docetaxel) u immedjatament wara d-dożi ta' wara ta' trastuzumab jekk id-doża preċedenti ta' trastuzumab kienet tollerata tajjeb.
English: The rate of asymptomatic cardiac dysfunction was increased in the 2-year treatment arm (8.1% versus 4.6% in the 1-year treatment arm).
Maltese: Ir-rata ta' disfunzjoni kardijaka mingħajr sintomi żdiedet fil-grupp ta' trattament ta' sentejn (8.1% kontra 4.6% fil-grupp ta' trattament ta' sena waħda).
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: All candidates for treatment with KANJINTI, 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 trattament b'KANJINTI, 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: Breast inflammation/mastitis
Maltese: Infjammazzjoni tas-sider/mastite
English: HER2 overexpression should be detected using an immunohistochemistry (IHC)-based assessment of fixed tumour blocks (see section 4.4).
Maltese: Espressjoni żejda ta' HER2 għandha tiġi osservata permezz ta' analiżi bbażata fuq immunoistokimika (IHCimmunohistochemistry) ta' blokki fissi tat-tumur (ara sezzjoni 4.4).
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' data PK dwar trastuzumab minn Studju M77004 fejn nisa b'MBC pożittiv għal HER2 kienu ttrattati b'trastuzumab, paclitaxel u doxorubicin fl-istess waqt ma' data 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: 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: In addition, terms reported in the post marketing setting are included in Table 1.
Maltese: Barra minn hekk, it-termini rrappurtati fl-ambjent ta' wara t-tqegħid fis-suq huma inklużi fit-Tabella 1.
English: Contusion
Maltese: Astenja
English: AC→D = doxorubicin plus cyclophosphamide, followed by docetaxel; AC→DH = doxorubicin plus cyclophosphamide, followed by docetaxel plus trastuzumab; CI = confidence interval Table 10 Overview of efficacy analyses BCIRG 006 AC→D versus DCarbH
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 Tabella 10.
English: MBC EBC Table 15 Population predicted steady-state PK exposure values (median with 5th - 95th percentiles) for trastuzumab intravenous dosing regimens in MBC, EBC and AGC patients
Maltese: Valuri mbassra tal-esponiment PK tal-popolazzjoni fi stat fiss (medjan b'5 - 95 percentiles) għal korsijiet ta' dożaġg ta' trastuzumab fil-vini f'pazjenti b'MBC, EBC u AGC
English: In the pivotal trial of docetaxel (100 mg/m2 infused over 1 hour) with or without trastuzumab, 60% of the patients had received prior anthracycline-based adjuvant chemotherapy.
Maltese: Fil-prova pivitali ta' docetaxel (100 mg/m2 mogħti bħala infużjoni fuq medda ta' siegħa) bi jew mingħajr trastuzumab, 60% tal-pazjenti kienu rċevew kimoterapija awżiljarja bbażata fuq anthracycline minn qabel.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1281/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1281/001
English: Cmax,ss to Cmin,ss
Maltese: Firxa ta' t1/2 minn Cmax,ss sa Cmin,ss (jum)
English: The efficacy results from study BO18225 are summarised in table 13: Table 13 Efficacy results from BO18225
Maltese: Ir-riżultati tal-effikaċja minn studju BO18225 huma miġbura fil-qosor f'tabella 13: Tabella 13.
English: Death (OS event) No. patients with event p = 0.0024
Maltese: Mewt (avveniment OS): Numru ta' pazjenti bl-avveniment p = 0.0024
English: 420 mg vial
Maltese: Kunjett ta' 420 mg
English: Rhinorrhoea
Maltese: Rinoreja
English: Retinal haemorrhage
Maltese: Emorraġija fir-retina
English: Median duration of follow-up was 1.8 years in the AC→P arm and 2.0 years in the AC→PH arm ** Median duration of long term follow-up for the Joint Analysis clinical studies was 8.3 years (range: 0.1 to 12.1) for the AC→PH arm and 7.9 years (range: 0.0 to 12.2) for the AC→P arm; Median duration of long term follow-up for the BCIRG 006 study was 10.3 years in both the AC→D arm (range: 0.0 to 12.6) arm and the DCarbH arm (range: 0.0 to 13.1), and was 10.4 years (range: 0.0 to 12.7) in the AC→DH arm
Maltese: It-tul ta' żmien medjan ta' segwitu kien ta' 1.8 snin fil-grupp ta' AC→P u sentejn fil-grupp ta' AC→PH ** It-tul medjan ta' segwitu fit-tul għall-istudji kliniċi tal-Analiżi konġunta kien ta' 8.3 snin (firxa: 0.1 sa 12.1) għall-grupp ta' AC→PH u 7.9 snin (firxa: 0.0 sa 12.2) għall-grupp ta' AC→P;
English: +1Wheezing
Maltese: +1Tħarħir
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 millinqas wieħed mill-fatturi li ġejjin: daqs tat-tumur akbar minn 2 ċm, negattivi għar-riċetturi taloestrogen u riċetturi tal-progesterone, grad istoloġiku u/jew nukleari ta' 2-3, jew età ta' < 35 sena).
English: Chills
Maltese: Tqalligħ
English: Serious reactions have been treated successfully with supportive therapy such as oxygen, beta-agonists, and corticosteroids.
Maltese: Reazzjonijiet serji kienu ttrattati b'suċċess b'terapija ta' appoġġ bħal ossiġnu, agonisti beta, u kortikosterojdi.
English: A two-compartment model with parallel linear and non-linear elimination from the central compartment described the trastuzumab concentration-time profile.
Maltese: Mudell ta' żewġ kompartimenti b'eliminazzjoni parallela lineari u mhux lineari mill-kompartiment ċentrali ddeskriva l-profil tal-konċentrazzjoni-ħin ta' trastuzumab.
English: Table 14 Population predicted cycle 1 PK exposure values (median with 5th - 95th percentiles) for trastuzumab intravenous dosing regimens in MBC, EBC and AGC patients
Maltese: Valuri mbassra tal-esponiment PK tal-popolazzjoni ta' ċiklu 1 (medjan b'5 - 95 percentiles) għal korsijiet ta' dożaġg ta' trastuzumab fil-vini f'pazjenti b'MBC, EBC u AGC
English: KANJINTI and anthracyclines should not be given concurrently in combination in the MBC setting.
Maltese: KANJINTI u anthracyclines m'għandhomx jingħataw fl-istess waqt flimkien f'sitwazzjoni ta' MBC.
English: The appropriate amount of solution should be withdrawn from the vial and added to a polyvinylchloride, polyethylene or polypropylene infusion bag containing 250 mL of sodium chloride 9 mg/mL (0.9%) solution for injection.
Maltese: L-ammont xieraq ta' soluzzjoni għandu jittella' mill-kunjett u jiżdied ma' borża tal-infużjoni magħmula minn polyvinylchloride, polyethylene jew polypropylene li jkun fiha 250 mL ta' soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9%) sodium chloride.
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 trattament b'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: In a population pharmacokinetic analysis, age and renal impairment were not shown to affect trastuzumab disposition.
Maltese: F'analiżi farmakokinetika tal-popolazzjoni, l-età u indeboliment tal-kliewi ma ntwerewx li għandhom effett fuq id-dispożizzjoni ta' trastuzumab.
English: or
Maltese: JIS
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 fil-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: 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 avvanzat tal-istonku biex jistudja lfarmakokinetika ta' capecitabine u cisplatin meta jintużaw ma' jew mingħajr trastuzumab.
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 μg/mL (madwar 3% ta' Cmin,ss imbassra talpopolazzjoni, jew eliminazzjoni kompluta ta' madwar 97%) wara 7 xhur.
English: Baseline levels of the shed HER2-ECD observed in MGC patients were comparable to those in MBC and EBC patients and no apparent impact on trastuzumab clearance was observed.
Maltese: Livelli fil-linja bażi ta' shed HER2-ECD osservati f'pazjenti b'MGC kienu komparabbli ma' dawk f'pazjenti b'MBC u EBC u ma kien osservat l-ebda impatt evidenti fuq it-tneħħija ta' trastuzumab.
English: Patients who receive anthracyclines after stopping KANJINTI may possibly be at increased risk of cardiac dysfunction.
Maltese: Pazjenti li jirċievu anthracyclines wara l-waqfien ta' KANJINTI jistgħu jkunu f'riskju akbar ta' disfunzjoni kardijaka.
English: Trastuzumab washout period was assessed following q1w or q3w intravenous administration using the population PK model.
Maltese: Il-perjodu biex Trastuzumab jiġi eliminat kompletament kien evalwat wara għoti q1w jew q3w fil-vini bl-użu tal-mudell PK tal-popolazzjoni.
English: In the adjuvant treatment setting, trastuzumab was investigated in 4 large multicentre, randomised, trials.
Maltese: Fl-ambjent ta' trattament awżiljarju, trastuzumab kien investigat f'4 provi kbar, b'aktar minn ċentru wieħed u randomised:
English: Paediatric population There is no relevant use of trastuzumab in the paediatric population.
Maltese: M'hemm l-ebda użu rilevanti ta' trastuzumab fil-popolazzjoni pedjatrika.