FrancophonIA/ELRC3.0 huggingface dataset:
English: L-histidine hydrochloride L-histidine α,α-trehalose dihydrate Polysorbate 20
Maltese: L-histidine hydrochloride L-histidine ,-trehalose dihydrate polysorbate 20
English: In BCIRG 006 study, 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: Fl-istudju BCIRG 006, 213/1075 pazjent fil-grupp DCarbH (TCH) , 221/1074 pazjent fil-grupp AC→DH (AC→TH), u 217/1073 fil-grupp AC→D (AC→T) kellhom stat ta' ħila Karnofsky ta' ≤ 90 (80 jew ≤ 90).
English: MBC and EBC patients had similar PK parameters (e.g. clearance [CL], the central compartment volume [Vc]) and population-predicted steady-state exposures (Cmin, Cmax and AUC).
Maltese: Pazjenti b'MBC u EBC kellhom parametri PK (eż. tneħħija [CL - clearance], volum tal-kompartiment ċentrali [Vc - central compartment volume]) u esponimenti fi stat fiss imbassra mill-popolazzjoni (Cmin, Cmax u AUC) simili.
English: Total CL range from Cmax,ss to Cmin,ss (L/day)
Maltese: Firxa ta' CL totali minn Cmax,ss sa Cmin,ss (L/jum)
English: For storage conditions after reconstitution of the medicinal product, see section 6.3 and 6.6.
Maltese: Għall-kondizzjonijiet ta' ħażna wara r-rikostituzzjoni tal-prodott mediċinali, ara sezzjoni 6.3 u 6.6.
English: Trastuzumab washout
Maltese: Jekk tieqaf tuża Herzuma
English: Infusion-related reactions and hypersensitivity
Maltese: Reazzjonijiet relatati mal-infużjoni u sensittività eċċessiva
English: For overall survival, the HR was 0.75 (95% CI 0.51 - 1.11) in the IHC 2+/FISH+ group and the HR was 0.58 (95% CI 0.41 - 0.81) in the IHC 3+/FISH+ group.
Maltese: Għas-sopravivenza globali, HR kien ta' 0.75 (CI ta' 95% 0.51 - 1.11) fil-grupp ta' IHC 2+/FISH+ u HR kien ta' 0.58 (CI ta' 95% 0.41 - 0.81) fil-grupp ta' IHC 3+/FISH+.
English: Other medicines and Herzuma
Maltese: Mediċini oħra u Herzuma
English: Reversibility of severe CHF (defined as a sequence of at least two consecutive LVEF values ≥ 50% after the event) was evident for 71.4% of trastuzumab-treated patients.
Maltese: Riversibilità ta' CHF severa (definita bħala sekwenza ta' mill-inqas żewġ valuri konsekuttivi ta' LVEF ta' ≥ 50% wara l-avveniment) kienet evidenti għal 71.4% tal-pazjenti kkurati bi trastuzumab.
English: No incompatibilities between Herzuma and polyvinylchloride, polyethylene or polypropylene bags have been observed.
Maltese: Ma kinux osservati inkompatibilitajiet bejn Herzuma u boroż tal-polyvinylchloride, polyethylene jew polypropylene.
English: In the pivotal metastatic trials of intravenous trastuzumab, the incidence of cardiac dysfunction varied between 9% and 12% when it was combined with paclitaxel compared with 1% - 4% for paclitaxel alone.
Maltese: Fil-provi pivitali dwar metastasi bi trastuzumab ġol-vini, l-inċidenza ta' disfunzjoni kardijaka varjat bejn 9% u 12% meta dan kien ikkombinat ma' paclitaxel meta mqabbla ma' 1% - 4% għal paclitaxel waħdu.
English: Cmax,ss** (μg/mL)
Maltese: Cmax,ss** (µg/mL)
English: Trastuzumab 1 Year N = 1693
Maltese: Trastuzumab Sena Waħda N = 1693
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%; p=0.004).
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: Treatment with AC→PH resulted in a statistically significant improvement in OS compared with AC→P (stratified HR=0.64; 95% CI [0.55, 0.74]; log-rank p-value < 0.0001).
Maltese: Kura b'AC→PH irriżultat f'titjib statistikament sinifikanti f'OS meta mqabbel ma'AC→P (HR stratifikat = 0.64; CI ta' 95% [0.55, 0.74]; valur p log-rank < 0.0001).
English: AUC0-21days (μg.day/mL)
Maltese: AUC0 - 21jum (µg.jum/mL)
English: SISH technology is however, recommended to allow for the parallel evaluation of tumour histology and morphology.
Maltese: Madankollu teknoloġja SISH hija rakkomandata biex tippermetti l-valutazzjoni parallella tal-istoloġija u l-morfoloġija tat-tumur.
English: Herzuma contains the active substance trastuzumab, which is a monoclonal antibody.
Maltese: Herzuma fih is-sustanza attiva trastuzumab, li huwa antikorp monoklonali.
English: PHARMACEUTICAL PARTICULARS
Maltese: Mundipharma Pharmaceuticals
English: In the pivotal trial (BO16216), trastuzumab and anastrozole were administered from day 1.
Maltese: Fil-prova pivitali (BO16216) trastuzumab u anastrozole ingħataw mill-ewwel ġurnata.
English: Additionally, trastuzumab is a potent mediator of antibody-dependent cell-mediated cytotoxicity (ADCC).
Maltese: Barra minn hekk, trastuzumab huwa medjatur qawwi ta' ċitotossiċità medjata miċ-ċelluli dipendenti minn antikorpi (ADCC - antibody-dependent cell-mediated cytotoxicity).
English: Tlf: + 47 40 00 42 10
Maltese: Orion Pharma AS Tlf: + 47 40 00 42 10
English: In this section, the following categories of frequency have been used: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: F'din is-sezzjoni, kienu wżati l-kategoriji ta' frekwenza li ġejjin: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Table 9 Overview of efficacy analyses BCIRG 006 AC→D versus AC→DH
Maltese: Tabella 9 Sommarju tal-analiżi tal-effikaċja ta' BCIRG 006 AC→D kontra AC→DH
English: - intravenous cyclophosphamide, at 600 mg/m over 30 minutes, given every 3 weeks for
Maltese: - cyclophosphamide ġol-vini, b'doża ta' 600 mg/m fuq medda ta' 30 minuta, mogħti kull
English: Table 10 Overview of efficacy analyses BCIRG 006 AC→D versus DCarbH
Maltese: Tabella 10 Sommarju tal-analiżi tal-effikaċja ta' BCIRG 006 AC→D kontra DCarbH Parametru
English: Mundipharma Pharmaceuticals B.V Tel: + 31 33 450 8270
Maltese: B.V Tel: + 31 33 450 8270
English: Trastuzumab is a recombinant humanised IgG1 monoclonal antibody against the human epidermal growth factor receptor 2 (HER2).
Maltese: IgG1 kontra ir-riċettur tal-fattur tat-tkabbir epidermali uman 2 (HER2 - human epidermal growth factor receptor 2).
English: Excipients: L-histidine hydrochloride, L-histidine, polysorbate 20, α,α-trehalose dihydrate.
Maltese: L-histidine hydrochloride, L-histidine, polysorbate 20, ,-trehalose dihydrate.
English: Table 11 Post-hoc exploratory analysis results from the joint analysis NSABP B-31/NCCTG N9831 and BCIRG 006 clinical studies combining DFS events and symptomatic cardiac events
Maltese: Tabella 11 Riżultati tal-analiżi esploratorja post-hoc mill-analiżi konġunta tal-istudji kliniċi NSABP B-31/NCCTG N9831* u BCIRG006 li jikkombinaw avvenimenti ta' DFS u avvenimenti sintomatiċi tal-qalb
English: - The NSABP B-31 and NCCTG N9831 studies that comprise the joint analysis were designed to investigate the clinical utility of combining trastuzumab treatment with paclitaxel following AC chemotherapy, additionally the NCCTG N9831 study also investigated adding trastuzumab sequentially to AC→P chemotherapy in patients with HER2 positive EBC following surgery.
Maltese: - L-istudji NSABP B-31 u NCCTG N9831 li jinkludu l-analiżi konġunta kienu maħsuba biex jinvestigaw l-utilità klinika li kura bi trastuzumab tingħata flimkien ma' paclitaxel wara kimoterapija AC, barra dan l-istudju NCCTG N9831 investiga wkoll iż-żieda sekwenzjali ta' trastuzumab ma' kimoterapija AC → P f'pazjenti b'EBC pożittiv għal HER2 wara kirurġija.
English: The highest rate of cardiac dysfunction was seen in patients receiving trastuzumab concurrently with anthracycline/cyclophosphamide (27%), and was significantly higher than for anthracycline/cyclophosphamide alone (7% - 10%).
Maltese: L-ogħla rata ta' disfunzjoni kardijaka dehret f'pazjenti li kienu qed jirċievu trastuzumab flimkien ma' anthracycline/cyclophosphamide (27%), u kienet ogħla b'mod sinifikanti milli għal anthracycline/cyclophosphamide waħedhom (7% - 10%).
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: F'analiżi esploratorja tas-sottogrupp li saret fil-prova TOGA (BO18255), ma kien hemm l-ebda benefiċċju apparenti fuq is-sopravivenza globali biż-żieda ta' trastuzumab f'pazjenti b'marda 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: The reconstituted Herzuma solution contains 21 mg/mL of trastuzumab.
Maltese: Is-soluzzjoni rikostitwita ta' Herzuma fiha 21 mg/mL ta' trastuzumab.
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 bi trastuzumab hija assoċjata ma' tnaqqis ta' 24% fir-riskju meta mqabbel ma' osservazzjoni biss (HR = 0.76, CI ta' 95% 0.67, 0.86).
English: Studies of HER2-positivity rates in gastric cancer (GC) using immunohistochemistry (IHC) and fluorescence in situ hybridisation (FISH) or chromogenic in situ hybridisation (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: Studji dwar ir-rati ta' posittività għal HER2 f'kanċer tal-istonku (GC - gastric cancer) bl-użu ta' immunoistokimika (IHC - immunohistochemistry) u fluorescence in situ hybridisation (FISH) jew chromogenic in situ hybridisation (CISH) urew li hemm varjazzjoni kbira fil-posittività għal HER2 li tvarja minn 6.8% sa 34.0% għal IHC u 7.1% sa 42.6% għal FISH.
English: Cmax (μg/mL)
Maltese: Cmax (µg/mL)
English: Pharmacokinetic data from studies BO15935 and M77004 in women with HER2-positive MBC suggested that exposure to paclitaxel and doxorubicin (and their major metabolites 6-α hydroxyl-paclitaxel, POH, and doxorubicinol, DOL) was not altered in the presence of trastuzumab (8 mg/kg or 4 mg/kg intravenous loading dose followed by 6 mg/kg q3w or 2 mg/kg q1w intravenous, respectively).
Maltese: Dejta farmakokinetika minn studji BO15935 u M77004 fuq nisa b'MBC pożittiv għal HER2 issuġġeriet li esponiment għal paclitaxel u doxorubicin (u l-metaboliti prinċipali tagħhom 6-α hydroxyl-paclitaxel, POH, u doxorubicinol, DOL) ma kienx mibdul fil-preżenza ta' trastuzumab (doża għolja tal-bidu ta' 8 mg/kg jew ta' 4 mg/kg ġol-vini segwita minn 6 mg/kg q3w jew 2 mg/kg q1w ġolvini, rispettivament).
English: Cmin (μg/mL)
Maltese: Cmin (µg/mL)
English: *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 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)
English: Post-hoc exploratory analysis with DFS and symptomatic cardiac events Long term follow-up hazard ratios (95% CI)
Maltese: Proporzjonijiet ta' periklu talanaliżi esploratorja post-hoc ta' Segwitu fit-tul ta' DFS u ta' avvenimenti sintomatiċi tal-qalb (CI ta' 95%)
English: Table 16 Population predicted PK parameter values at steady state for trastuzumab intravenous dosing regimens in MBC, EBC and AGC patients
Maltese: Tabella 16 Valuri mbassra tal-parametru PK tal-popolazzjoni fi stat fiss għal korsijiet ta' dożaġg ta' trastuzumab ġol-vini f'pazjenti b'MBC, EBC u AGC
English: In a method comparison study (study D008548), a high degree of concordance (> 95%) was observed for SISH and FISH techniques for the detection of HER2 gene amplification in gastric cancer patients.
Maltese: Fi studju li pparaguna l-metodu (studju D008548), kien osservat grad għoli ta' konkordanza (> 95%) għal tekniki SISH u FISH għall-osservazzjoni tal-amplifikazzjoni tal-ġene HER2 f'pazjenti b'kanċer tal-istonku.
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, mekkaniżmu ta' attivazzjoni ta' HER2.
English: Table 8 Final overall survival analysis from the joint analysis of trials NSABP B-31 and NCCTG N9831
Maltese: Tabella 8 Analiżi finali tas-sopravivenza globali mill-analiżi konġunta tal-provi NSABP B-31 u NCCTG N9831
English: The median overall survival for the high HER2 expressing group was 11.8 months versus 16 months, HR 0.65 (95% CI 0.51 - 0.83) and the median progression free survival was 5.5 months versus 7.6 months, HR 0.64 (95% CI 0.51 - 0.79) for FP versus FP + H, respectively.
Maltese: Is-sopravivienza globali medjana għall-grupp b'espressjoni għolja ta' HER2 kienet ta' 11.8 xhur kontra 16-il xahar, HR 0.65 (CI ta' 95% 0.51 - 0.83) u is-sopravivenza mingħajr progressjoni medjana kienet ta' 5.5 xhur kontra 7.6 xhur, HR 0.64 (CI ta' 95% 0.51 - 0.79) għal FP kontra FP + H, rispettivament.
English: For the other parameters the improvements seen for the combination were for overall response (16.5% versus 6.7%); clinical benefit rate (42.7% versus 27.9%); time to progression (4.8 months versus 2.4 months).
Maltese: Għall-parametri l-oħra t-titjib li deher għall-kura kombinata kien għar-rispons globali (16.5% kontra 6.7%); rata ta' benefiċċju kliniku (42.7% kontra 27.9%); żmien sal-progressjoni (4.8 xhur kontra 2.4 xhur).
English: In this final analysis, extending trastuzumab treatment for a duration of two years did not show additional benefit over treatment for 1 year [DFS HR in the intent to treat (ITT) population of 2 years versus 1 year=0.99 (95% CI: 0.87, 1.13), p-value=0.90 and OS HR=0.98 (0.83, 1.15); p-value=0.78].
Maltese: [DFS HR fil-popolazzjoni b'intenzjoni li jiġu kkurati (ITT - intent to treat) ta' sentejn kontra sena waħda = 0.99 (CI ta' 95%: 0.87, 1.13), valur p = 0.90 u OS HR = 0.98 (0.83, 1.15); valur p = 0.78].
English: s r.o Tel: + 420 227 129 111
Maltese: Česká republika EGIS Praha, spol. s r.o Tel: + 420 227 129 111
English: More patients treated with trastuzumab and paclitaxel progressed in the central nervous system than those treated with paclitaxel alone (12.6% versus 6.5%; p=0.377).
Maltese: Numru akbar ta' pazjenti kkurati bi trastuzumab u paclitaxel kellhom progressjoni fis-sistema nervuża ċentrali minn dawk ikkurati b'paclitaxel waħdu (12.6% kontra 6.5%, p = 0.377).
English: In patients receiving trastuzumab after completion of adjuvant chemotherapy, the risk of cardiac dysfunction was associated with a higher cumulative dose of anthracycline given prior to initiation of trastuzumab and a body mass index (BMI) > 25 kg/m
Maltese: F'pazjenti li qed jirċievu trastuzumab wara li tkun kompluta kimoterapija awżiljarja, ir-riskju ta' disfunzjoni kardijaka kienet assoċjata ma' doża kumulattiva ogħla ta' anthracycline mogħti qabel il-bidu ta' trastuzumab u indiċi tal-massa tal-ġisem (BMI - body mass index) ta' > 25 kg/m
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 after a taxane (0.3 - 0.4%).
Maltese: Fi 3 provi kliniċi pivitali bi 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: 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: Ma kien innutat l-ebda benefiċċju ta' sopravivenza mingħajr il-marda (DFS - disease-free survival) f'dan is-sottogrupp ta' pazjenti (proporzjon ta' periklu = 1.16, CI ta' 95% [0.73, 1.83] għal DCarbH (TCH) kontra AC→D (AC→T); proporzjon ta' periklu = 0.97, CI ta' 95% [0.60, 1.55] għal AC→DH (AC→TH) kontra AC→D).
English: The vial contains 150 mg trastuzumab.
Maltese: Il-kunjett fih 150 mg trastuzumab.
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 avanzata (> 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: Other side effects that have been reported with Herzuma use (frequency cannot be estimated from the available data):
Maltese: Effetti sekondarji oħra li kienu rrappurtati bl-użu ta' Herzuma (frekwenza ma tistax tittieħed stima mid-data disponibbli):
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 hemodynamic 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 (pressjoni għolja kkontrollata minn kura medika standard eliġġibbli), u effużjoni perikardjali emodinamika effettiva kienu esklużi mill-provi pivitali awżiljarji u neo-awżiljari dwar EBC bi trastuzumab u għalhekk ma tistax tiġi rakkomandata kura f'dawn il-pazjenti.
English: - intravenous 5-fluorouracil - 800 mg/m 2/day as a continuous intravenous infusion over 5 days, given every 3 weeks for 6 cycles (days 1 to 5 of each cycle)
Maltese: - 5-fluorouracil ġol-vini - 800 mg/m2/jum bħala infużjoni kontinwa ġol-vini fuq 5 ijiem, mogħtija kull 3 ġimgħat għal 6 ċikli (ġranet 1 sa 5 ta' kull ċiklu)
English: Single doses of Herzuma alone greater than 10 mg/kg have not been administered in the clinical trials; a maintenance dose of 10 mg/kg q3w following a loading dose of 8 mg/kg has been studied in a clinical trial with metastatic gastric cancer patients.
Maltese: Dożi singoli ta' Herzuma waħdu ta' aktar minn 10 mg/kg ma kinux mogħtija fi studji kliniċi; doża ta' manteniment ta' 10 mg/kg q3w wara doża ogħla tal-bidu ta' 8 mg/kg ġiet studjata fi prova klinika b'pazjenti b'kanċer metastatiku talistonku.
English: Death (OS event): No. patients with event p=0.014
Maltese: Mewt (avveniment OS): Numru ta' pazjenti bl-avveniment p = 0.014
English: Herzuma is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC):
Maltese: Herzuma huwa indikat għall-kura ta' pazjenti adulti b'kanċer metastatiku tas-sider (MBC - metastatic breast cancer) pożittiv għal HER2:
English: The pharmacokinetics of trastuzumab were evaluated in a population pharmacokinetic model analysis using pooled data from 1,582 subjects, including patients with HER2 positive MBC, EBC, AGC or other tumour types, and healthy volunteers, in 18 Phase I, II and III trials receiving trastuzumab intravenous.
Maltese: Il-farmakokinetika ta' trastuzumab kienet evalwata f'analiżi ta' mudell tal-farmakokinetika tal-popolazzjoni bl-użu ta' dejta miġbura minn 1,582 individwu, fosthom pazjenti b'MBC, EBC, AGC jew tipi oħra ta' tumuri pożittivi għal HER2, u voluntiera f'saħħithom, fi 18-il prova ta' Fażi I, II u III li kienu qed jirċievu trastuzumab ġol-vini.
English: Table 4 Efficacy results from the monotherapy and combination therapy studies
Maltese: Tabella 4: Riżultati tal-effikaċja mill-istudji ta' monoterapija u ta' terapija kombinata
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 għall-provi 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: Combination treatment with trastuzumab and anastrozole
Maltese: Kura kombinata bi trastuzumab u anastrozole
English: Serious IRRs to Herzuma 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' Herzuma inkluż qtugħ ta' nifs, pressjoni baxxa, tħarħir, pressjoni għolja, bronkospażmu, takiarritmija supraventrikulari, saturazzjoni ta' ossiġnu mnaqqsa, anafilassi, distress respiratorju, urtikarja u anġjoedima (ara sezzjoni 4.8).
English: Herzuma 150 mg powder for concentrate for solution for infusion Herzuma 420 mg powder for concentrate for solution for infusion
Maltese: Herzuma 150 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Herzuma 420 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: In one of the 3 pivotal studies conducted in which a median follow-up of 5.5 years was available (BCIRG006) a continuous increase in the cumulative rate of symptomatic cardiac or LVEF events was observed in patients who were administered trastuzumab concurrently with a taxane following anthracycline therapy up to 2.37% compared to approximately 1% in the two comparator arms (anthracycline plus cyclophosphamide followed by taxane and taxane, carboplatin and trastuzumab).
Maltese: F'wieħed mit3 studji pivitali mwettqa fejn kien disponibbli segwitu medjan ta' 5.5 snin (BCIRG006) kienet osservata żieda kontinwa fir-rata kumulattiva ta' avvenimenti kardijaċi sintomatiċi jew avvenimenti ta' LVEF sa 2.37% f'pazjenti li ngħataw trastuzumab flimkien ma' taxane wara terapija b'anthracycline meta mqabbel ma madwar 1% fiż-żewġ gruppi ta' paragun (anthracycline flimkien ma'