FrancophonIA/ELRC3.0 huggingface dataset:
English: The test method for HER2 overexpression used to determine eligibility of patients in the pivotal trastuzumab monotherapy and trastuzumab plus paclitaxel clinical trials employed immunohistochemical staining for HER2 of fixed material from breast tumours using the murine monoclonal antibodies CB11 and 4D5.
Maltese: It-test użat biex titkejjel l-espressjoni żejda ta' HER2 sabiex jiġu determinati l-pazjenti eliġibbli għallprovi kliniċi pivitali ta' trastuzumab bħala monoterapija u ta' trastuzumab flimkien ma' paclitaxel għamel użu minn metodu immunoistokimiku ta' tbajja għal HER2 ta' materjal fiss minn tumuri tas sider bl-użu tal-antikorpi monoklonali tal-ġurdien CB11 u 4D5.
English: In study BCIRG 006, 213/1075 patients in the DCarbH (TCH) arm, 221/1074 patients in the AC→DH (AC→TH) arm, and 217/1073 in the AC→D (AC→T) arm had a Karnofsky performance status ≤90 (either 80 or 90).
Maltese: AC→DH (AC→TH), u 217/1073 fil-grupp ta' AC→D (AC→T) kellhom stat ta' ħila Karnofsky ta' ≤90 (80 jew 90).
English: Patients with history of myocardial infarction (MI), angina pectoris requiring medical treatment, history of or existing CHF (NYHA Class II-IV), LVEF of <55%, other cardiomyopathy, cardiac arrhythmia requiring medical treatment, clinically significant cardiac valvular disease, poorly controlled hypertension (hypertension controlled by standard medical treatment eligible), and haemodynamic effective pericardial effusion were excluded from adjuvant and neoadjuvant EBC pivotal trials with trastuzumab and therefore treatment cannot be recommended in such patients.
Maltese: II-IV) eżistenti, LVEF ta' < 55%, kardjomijopatija oħra, arritmija kardijaka li teħtieġ kura medika, mard klinikament sinifikanti tal-valvs tal-qalb, pressjoni għolja mhux ikkontrollata tajjeb biżżejjed (pazjenti bi pressjoni għolja kkontrollata minn kura medika standard kienu eliġibbli), u effużjoni perikardjali emodinamika effettiva kienu esklużi mill-provi pivitali awżiljarji u neo-awżiljari dwar EBC b'trastuzumab u għalhekk ma tistax tiġi rakkomandata kura f'dawn il-pazjenti.
English: • insomnia (inability to sleep)
Maltese: • insomnija (diffikultà biex torqod)
English: Long term follow-up efficacy analysis** DFS hazard ratios (95% CI) p-value p<0.0001
Maltese: segwitu fit-tul** Proporzjonijiet ta' periklu DFS (CI ta' 95 %) valur p p<0.0001
English: • depression
Maltese: • ansjetà • depressjoni
English: Trastuzumab is designed to bind selectively to an antigen called human epidermal growth factor receptor 2 (HER2).
Maltese: antiġen imsejjaħ riċettur tal-fattur tat-tkabbir epidermali uman 2 (HER2 - human epidermal growth factor receptor 2).
English: In an exploratory subgroup analysis performed in the TOGA (BO18255) trial there was no apparent benefit on overall survival with the addition of trastuzumab in patients with ECOG PS 2 at baseline [HR 0.96 (95% CI 0.51-1.79)], non-measurable [HR 1.78 (95% CI 0.87-3.66)] and locally advanced disease [HR 1.20 (95% CI 0.29-4.97)].
Maltese: ECOG PS 2 fil-linja bażi [HR 0.96 (CI ta' 95 % 0.51-1.79)], li ma tistax titkejjel [HR 1.78 (CI ta' 95 % 0.87-3.66)] u avanzata lokalment [HR 1.20 (CI ta' 95 % 0.29-4.97)].
English: Patients with MBC who have previously received anthracyclines are also at risk of cardiac dysfunction with trastuzumab treatment, although the risk is lower than with concurrent use of trastuzumab and anthracyclines.
Maltese: Pazjenti b'MBC li qabel kienu rċevew anthracyclines ukoll huma f'riskju ta' disfunzjoni kardijaka b'kura b'trastuzumab, għalkemm ir-riskju huwa inqas milli bl-użu fl-istess waqt ta' trastuzumab u anthracyclines.
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 (IHC - immunohistochemistry) ta' blokki fissi tat-tumur (ara sezzjoni 4.4).
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 konġunta 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: 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 tal-kura 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: A final analysis was performed after a median follow-up of 8 years, which showed that 1-year trastuzumab treatment is associated with a 24% risk reduction compared to observation only (HR=0.76, 95% CI 0.67, 0.86).
Maltese: Twettqet analiżi finali wara segwitu medjan ta' 8 snin, li wriet li kura ta' sena waħda b'trastuzumab hija assoċjata ma' tnaqqis ta' 24% fir-riskju meta mqabbel ma' osservazzjoni biss (HR=0.76, CI ta'
English: Table 6 Efficacy results from Study BO16348 Median follow-up 12 months*
Maltese: Tabella 6 Riżultati tal-effikaċja minn Studju BO16348
English: However, trastuzumab may elevate the overall exposure of one doxorubicin metabolite (7-deoxy-13 dihydro-doxorubicinone, D7D).
Maltese: deoxy-13 dihydro-doxorubicinone, D7D).
English: No disease-free survival (DFS) benefit was noticed in this subgroup of patients (hazard ratio=1.16, 95% CI [0.73, 1.83] for DCarbH (TCH) versus AC→D (AC→T); hazard ratio 0.97, 95% CI [0.60, 1.55] for AC→DH (AC→TH) versus AC→D).
Maltese: 1.83] għal DCarbH (TCH) kontra AC→D (AC→T); proporzjoni ta' periklu 0.97, 95% CI [0.60, 1.55] għal AC→DH (AC→TH) kontra AC→D).
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) filgrupp ta' AC→PH, benefiċċju assolut ta' 11.8% meta mqabbel mal-grupp ta' AC→P.
English: In addition, caution should be exercised in treating patients with increased cardiac risk, e.g. hypertension, documented coronary artery disease, CHF, LVEF of <55%, older age.
Maltese: Barra dan, għandu jkun hemm attenzjoni fil-kura ta' pazjenti b'riskju kardijaku miżjud, eż. pressjoni għolja, mard dokumentat tal-arterja koronarja, CHF, LVEF ta' <55%, xjuħija.
English: *Cmin,ss - Cmin at steady state **Cmax,ss = Cmax at steady state *** time to 90% of steady-state
Maltese: *** żmien sakemm jintlaħaq 90% ta' stat fiss
English: Solutions of Ontruzant for intravenous infusion are physically and chemically stable in polyvinylchloride, polyethylene or polypropylene bags containing sodium chloride 9 mg/mL (0.9%) solution for injection for 24 hours at temperatures not exceeding 30°C.
Maltese: Soluzzjonijiet ta' Ontruzant għall-infużjoni fil-vini huma fiżikament u kimikament stabbli għal 24 siegħa f'temperaturi li ma jaqbżux 30°C, f'boroż tal-polyvinylchloride, polyethylene jew polypropylene li fihom soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9 %) sodium chloride.
English: Table 14 Population predicted cycle 1 PK exposure values (median with 5th - 95th percentiles) for trastuzumab intravenous infusion dosing regimens in MBC, EBC and AGC patients
Maltese: Tabella 14 Valuri mbassra tal-esponiment PK tal-popolazzjoni ta' ċiklu 1 (medjan b'5 - 95 percentiles) għal korsijiet ta' dożaġg ta' infużjoni ġol-vini ta' trastuzumab f'pazjenti b'MBC, EBC u AGC
English: Ontruzant is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC):
Maltese: Ontruzant huwa indikat għall-kura ta' pazjenti adulti b'kanċer metastatiku tas-sider (MBCmetastatic breast cancer) pożittiv għal HER2:
English: Trastuzumab plus paclitaxel2 N=68
Maltese: Trastuzumab ma' docetaxel2 N=68
English: In a subsequent trial with prospective monitoring of cardiac function, the incidence of symptomatic CHF was 2.2% in patients receiving trastuzumab and docetaxel, compared with 0% in patients receiving docetaxel alone.
Maltese: sintomatika kienet ta' 2.2% f'pazjenti li rċevew trastuzumab u docetaxel, meta mqabbel ma' 0% filpazjenti li rċevew docetaxel waħdu.
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 (H0648g), suggested no effect of doxorubicin and paclitaxel on the pharmacokinetics of trastuzumab.
Maltese: Studju M77004 fejn nisa b'MBC pożittiv għal HER2 kienu kkurati b'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 (H0648g), ma jissuġġerixxi l-ebda effett ta' doxorubicin u paclitaxel fuq il-farmakokinetika ta' trastuzumab.
English: - intravenous cyclophosphamide, at 600 mg/m2 over 30 minutes, given every 3 weeks for 4 cycles.
Maltese: - cyclophosphamide fil-vini, b'doża ta' 600 mg/m2fuq medda ta' 30 minuta, mogħti kull
English: Rare side effects of Ontruzant (may affect up to 1 in 1000 people):
Maltese: Effetti sekondarji rari ta' Ontruzant (jistgħu jaffettwaw sa persuna waħda minn kull 1000):
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: The risk of neutropenia may be slightly increased when trastuzumab is administered with docetaxel following anthracycline therapy.
Maltese: Ir-riskju ta' newtropenijajista' jiżdied xi ftit meta trastuzumab jingħata flimkien ma' docetaxel wara terapija b'anthracycline.
English: Table 16 Population predicted PK parameter values at steady state for trastuzumab intravenous infusion dosing regimens in MBC, EBC and AGC patients
Maltese: Tabella 16 Valuri mbassra tal-parametri PK tal-popolazzjoni fl-istat fiss għal korsijiet ta' dożaġg ta' infużjoni ġol-vini ta' trastuzumab f'pazjenti b'MBC, EBC u AGC
English: Ontruzant 150 mg powder for concentrate for solution for infusion Ontruzant 420 mg powder for concentrate for solution for infusion trastuzumab
Maltese: Ontruzant 150 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Ontruzant 420 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
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 0.9% sodium chloride solution.
Maltese: L-ammont xieraq ta' soluzzjoni għandu jittella' mill-kunjett u jiżdied ma' borża tal-infużjoni magħmula minn polyvinylchloride, polyethylene jew polypropylene li fiha 250 mL ta' 0.9 % sodium chloride.
English: CI)
Maltese: N
English: Each 420 mg vial of Ontruzant is reconstituted with 20 mL of sterile water for injection (not supplied).
Maltese: Kull kunjett ta' Ontruzant 420 mg huwa rikostitwit b'20 mL ta' ilma għall-injezzjoni sterili (mhux ipprovdut).
English: The bioactivity of D7D and the clinical impact of the elevation of this metabolite was unclear.
Maltese: Il-bioattività ta' D7D u l-impatt kliniku tal-elevazzjoni ta'
English: Studies of HER2-positivity rates in gastric cancer (GC) using immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH) have shown that there is a broad variation of HER2-positivity ranging from 6.8% to 34.0% for IHC and 7.1% to 42.6% for FISH.
Maltese: immunohistochemistry) u fluorescence in situ hybridization (FISH) jew chromogenic in situ hybridization (CISH) urew li hemm varjazzjoni kbira fil-posittività għal HER2 li tvarja minn 6.8%
English: - intravenous 5-fluorouracil - 800 mg/m2/day as a continuous intravenous infusion over 5 days, given every 3 weeks for 6 cycles (days 1 to 5 of each cycle) Either of which was administered with: - cisplatin - 80 mg/m2 every 3 weeks for 6 cycles on day 1 of each cycle.
Maltese: - 5-fluorouracil fil-vini - 800 mg/m2/jum bħala infużjoni kontinwa fil-vini fuq 5 ijiem, mogħtija kull 3 ġimgħat għal 6 ċikli (ġranet 1 sa 5 ta' kull ċiklu)
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 għal79.5% tal-pazjenti.
English: Death (OS event) No. patients with event p=0.0024
Maltese: Mewt (avveniment ta' OS): Numru ta' pazjenti bl-avveniment p=0.0024
English: Hazard ratio versus observation *Co-primary endpoint of DFS of 1 year versus observation met the pre-defined statistical boundary **Final analysis (including crossover 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 randomized after the cut-off date for the 12-month median follow-up analysis
Maltese: 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: 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 medjan ta' segwitu fit-tul għall-istudju BCIRG 006 kien ta' 10.3 snin kemm fil-grupp ta' AC→D (firxa: 0.0 sa 12.6) kif ukoll fil-grupp ta' DCarbH (firxa: 0.0 sa 13.1), u kien ta' 10.4 snin (firxa: 0.0 sa 12.7) fil-grupp ta' AC→DH
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: Immune system disorders
Maltese: Disturbi fis-sistema immuni Sensittività eċċessiva
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: p-value versus
Maltese: Valur p kontraAC→P
English: Each 150 mg vial of Ontruzant is reconstituted with 7.2 mL of water for injections (not supplied).
Maltese: Kull kunjett ta' 150 mg ta' Ontruzant huwa rikostitwit b'7.2 mL ta' ilma għall-injezzjonijiet (mhux fornut).
English: P-value versus observation
Maltese: Valur p kontra Osservazzjoni Proporzjon ta' periklu kontra osservazzjoni
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 (JA - joint analysis) tal-istudji kliniċi NSABP B-31/NCCTG N9831* u BCIRG006 li jikkombinaw avvenimenti ta' DFS u avvenimenti sintomatiċi tal-qalb li huma miġbura fil-qosor f'Tabella 11:
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' trastuzumab u paclitaxel, meta mqabbel ma' paclitaxel waħdu (21.8% kontra 45.7%, p=0.004).
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 b'trastuzumab fil-vini bħala monoterapija jew flimkien ma' kimoterapija fi provi kliniċi pivitali (N=8386) u wara t-tqegħid fis-suq
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: The population predicted PK exposure values (median with 5th-95th Percentiles) and PK parameter values at clinically relevant concentrations (Cmax and Cmin) for MBC, EBC and AGC patients treated with the approved q1w and q3w dosing regimens are shown in Table 14 (Cycle 1), Table 15 (steady-state), and Table 16 (PK parameters).
Maltese: Il-valuri mbassra tal-esponiment PK tal-popolazzjoni (medjan b'5 - 95 Percentiles) u valuri tal parametru PK f'konċentrazzjonijiet klinikament rilevanti (Cmax u Cmin) għall-pazjenti b'MBC, EBC u AGC ikkurati bil-korsijiet ta' dożaġġ q1w u q3w approvati huma murija fit-Tabella 14 (Ċiklu 1),
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: Paediatric population There is no relevant use of Ontruzant in the paediatric population.
Maltese: M'hemmx użu rilevanti ta' Ontruzant fil-popolazzjoni pedjatrika.
English: in combination with neoadjuvant chemotherapy followed by adjuvant Ontruzant therapy, for locally advanced (including inflammatory) disease or tumours >2 cm in diameter (see sections 4.4 and 5.1).
Maltese: flimkien ma' kimoterapija awżiljarja li tikkonsisti minn docetaxel u carboplatin. flimkien ma' kimoterapija neoawżiljarja segwita minn terapija awżiljarja ta' Ontruzant, għall-mard avanzat lokalment (inkluż infjammatorju) jew tumuri b'dijametru ta' > 2 cm (ara sezzjonijiet 4.4 u 5.1).
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 l-farmakokinetika ta' capecitabine u cisplatin meta jintużaw ma' jew mingħajr trastuzumab.
English: Binding of trastuzumab to HER2 inhibits ligand-independent HER2 signalling and prevents the proteolytic cleavage of its extracellular domain, an activation mechanism of HER2.
Maltese: HER2 indipendenti mil-ligand u jipprevjeni l-qsim proteolitiku tad-dominju ekstraċellulari tiegħu,
English: All candidates for treatment with trastuzumab, 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 b'trastuzumab, 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: Ontruzant 420 mg powder for concentrate for solution for infusion
Maltese: Ontruzant 420 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: The data suggest that beneficial effects were greater among those patients with higher levels of overexpression of HER2 (3+).
Maltese: Id-dejta tindika li effetti tajbin kienu akbar fost dawk il pazjenti b'livelli ogħla ta' espressjoni żejda ta' HER2 (3+).
English: 420 mg vial
Maltese: Kunjett ta' 420 mg + 20 mL
English: Experience of concurrent administration of trastuzumab with low-dose anthracycline regimens is currently limited to the trial MO16432.
Maltese: Esperjenza ta' għoti fl-istess waqt ta' trastuzumab ma' korsijiet b'doża baxxa ta' antharacycline bħalissa hija limitata prova MO16432.
English: AC→PH (n=1672)
Maltese: (n=1672)
English: After reconstitution with sterile water for injection the reconstituted solution is physically and chemically stable for 48 hours at 2°C-8°C.
Maltese: Wara r-rikostituzzjoni b'ilma għall-injezzjoni sterili s-soluzzjoni rikostitwita hija fiżikament u kimikament stabbli għal 48 siegħa f'temperatura ta' 2°C-8°C.
English: The presence of anti-trastuzumab antibodies had no impact on 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 [EFS - event free survival]) u s-sigurtà determinati mill-okkorrenza ta' reazzjonijiet relatati mal-għoti (ARRs - administration related reactions) ta' trastuzumab fil-vini.
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC03 Ontruzant is a biosimilar medicinal product.
Maltese: Sustanzi antineoplastiċi, antikorpi monoklonali, Kodiċi ATC:
English: Ontruzant is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC).
Maltese: Ontruzant huwa indikat għall-kura ta' pazjenti adulti b'kanċer bikri tas-sider (EBC - early breast cancer) pożittiv għal HER2.
English: 1Tremor
Maltese: 1 kunjett
English: Hazard ratio vs AC→D (95% CI)
Maltese: Sopravivenza medjana (xhur) (CI ta' 95%)
English: - intravenous docetaxel - 75 mg/m2 as an intravenous infusion over 1 hour, given every 3 weeks for 6 cycles (day 2 of cycle 1, then day 1 of each subsequent cycle) which was followed by: - carboplatin - at target AUC=6 mg/mL/min administered by intravenous infusion over 30-60 minutes repeated every 3 weeks for a total of six cycles
Maltese: li kien segwit minn: - carboplatin - b'AUC mmirata=6 mg/mL/min mogħti permezz ta' infużjoni fil-vini fuq medda ta' 30-60 minuta ripetut kull 3 ġimgħat għal total ta' sitt ċikli
English: AC→PH (N=2031)
Maltese: (N=2031)
English: These include, but are not limited to, pulmonary infiltrates, acute respiratory distress syndrome, pneumonia, pneumonitis, pleural effusion, respiratory distress, acute pulmonary oedema and respiratory insufficiency (see section 4.4).
Maltese: Dawn jinkludu, iżda mhumiex limitati għal, infiltrati pulmonari, sindrome ta'distress respiratorju akut, pnewmonja, pulmonite, effużjoni fil-plewra, distress respiratorju, edima pulmonari akuta u insuffiċjenza respiratorja (ara sezzjoni 4.4).