FrancophonIA/ELRC3.0 huggingface dataset:
English: Serious IRRs to Herceptin 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' Herceptin 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: In study MO16432, Herceptin (8 mg/kg loading dose, followed by 6 mg/kg maintenance every 3 weeks) was administered concurrently with 10 cycles of neoadjuvant chemotherapy as follows:
Maltese: Fl-istudju MO16432, Herceptin (doża għolja tal-bidu ta' 8 mg/kg, segwit minn manteniment ta' 6 mg/kg kull 3 ġimgħat) ingħata flimkien ma' 10 ċikli ta' kimoterapija neoawżiljarja kif ġej:
English: • you are allergic to trastuzumab (the active substance of Herceptin), murine (mouse) proteins, or any of the other ingredients of this medicine (listed in section 6).
Maltese: • inti allerġiku/a għal trastuzumab (is-sustanza attiva ta' Herceptin), proteini tal-ġrieden, jew xi sustanza oħra ta' din il-mediċina (elenkati fis-sezzjoni 6).
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: Hazard ratios (95 % CI) A: doxorubicin; C: cyclophosphamide; P: paclitaxel; D: docetaxel; Carb: carboplatin; H: trastuzumab CI = confidence interval
Maltese: Proporzjonijiet ta' periklu talanaliżi esploratorja post-hoc ta' Segwitu fit-tul** ta' DFS u ta' avvenimenti sintomatiċi talqalb (CI ta' 95 %) A: doxorubicin; C: cyclophosphamide; P: paclitaxel; D: docetaxel; Carb: carboplatin; H: trastuzumab CI = intervall ta' kunfidenza * Fil-ħin tal-analiżi definittiva ta' DFS.
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 Herceptin 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 b'Herceptin u għalhekk ma tistax tiġi rakkomandata kura f'dawn il-pazjenti.
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 (tumor size > 1 cm and ER negative or tumor 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: Herceptin 150 mg powder for concentrate for solution for infusion Trastuzumab
Maltese: Herceptin 150 mg trab għal konċentrat
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
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.
English: More patients treated with Herceptin 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 b'Herceptin u paclitaxel kellhom progressjoni fis-sistema nervuża ċentrali minn dawk ikkurati b'paclitaxel waħdu (12.6 % kontra 6.5 %, p=0.377).
English: (n=1073)
Maltese: AC→D (n=1073)
English: In the pivotal trials (H0648g, M77001), paclitaxel or docetaxel was administered the day following the first dose of Herceptin (for dose, see the Summary of Product Characteristics (SmPC) for paclitaxel or docetaxel) and immediately after the subsequent doses of Herceptin if the preceding dose of Herceptin was well tolerated.
Maltese: Fil-provi pivitali (H0648g, M77001), paclitaxel jew docetaxel ingħata l-għada tal-ewwel doża ta' Herceptin (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' Herceptin jekk id-doża preċedenti ta' Herceptin kienet tollerata tajjeb.
English: LIST OF EXCIPIENTS L-histidine hydrochloride monohydrate, L-histidine, polysorbate 20, α,α-trehalose dihydrate.
Maltese: L-histidine hydrochloride monohydrate, L-histidine, polysorbate 20, α,α-trehalose dihydrate.
English: In the pivotal trial, the rate of all grade ARRs was 37.2 % with the Herceptin intravenous formulation and 47.8 % with the Herceptin subcutaneous formulation; severe grade 3 reactions were reported in 2.0 % and 1.7 % of the patients, respectively during the treatment phase; no severe grade 4 or 5 reactions were observed.
Maltese: Fil-prova pivitali, ir-rata ta' ARRs ta' kull grad kienet ta' 37.2 % bil-formulazzjoni għall-għoti fil-vini ta' Herceptin u ta' 47.8 % bil-formulazzjoni għall-għoti taħt il-ġilda ta' Herceptin; reazzjonijiet severi ta' grad 3 kienu rrappurtati fi 2.0 % u 1.7 % tal-pazjenti, rispettivament waqt il-fażi ta' kura; ma kinux osservati reazzjonijiet severi ta' grad 4 jew 5.
English: Herceptin is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC):
Maltese: Herceptin huwa indikat għall-kura ta' pazjenti adulti b'kanċer metastatiku tas-sider (MBC - metastatic breast cancer) pożittiv għal HER2:
English: Some adverse events / reactions were reported with a higher frequency for the subcutaneous formulation:
Maltese: Xi avvenimenti/reazzjonijiet avversi kienu rrappurtati bi frekwenza ogħla għall-formulazzjoni għallgħoti taħt il-ġilda:
English: AC→D = doxorubicin plus cyclophosphamide, followed by docetaxel; DCarbH = docetaxel, carboplatin and trastuzumab; CI = confidence interval
Maltese: AC→D = doxorubicin u cyclophosphamide, segwit minn docetaxel; DCarbH = docetaxel, carboplatin u trastuzumab; CI = intervall ta' kunfidenza
English: The AUC0-21 days following Cycle 12 dose was approximately 20 % higher with the Herceptin subcutaneous formulation than the Herceptin intravenous dose, with mean AUC values of 2610 µg/mL•day and 2179 µg/mL•day, respectively.
Maltese: L-AUC0-21 ġurnata wara d-doża ta' Ċiklu 12 kienet madwar 20% ogħla bil-formulazzjoni għall-għoti taħt il-ġilda ta' Herceptin milli bid-doża ta' Herceptin fil-vini, b'valuri tal-medja tal-AUC ta' 2610 µg/mL•kuljum u 2179 µg/mL•kuljum, rispettivament.
English: In the pivotal trial MO16432, Herceptin was administered concurrently with neoadjuvant chemotherapy containing three cycles of doxorubicin (cumulative dose 180 mg/m2 ) .
Maltese: MO16432, Herceptin ingħata flimkien ma' kimoterapija neoawżiljarja li kien fiha tliet ċikli ta' doxorubicin (doża kumulattiva ta' 180 mg/m
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 jkun fiha 250 mL ta' 0.9 % sodium chloride.
English: If possible, physicians should avoid anthracycline-based therapy for up to 7 months after stopping Herceptin.
Maltese: Jekk possibbli, it-tobba għandhom jevitaw terapija bbażata fuq anthracycline għal sa 7 xhur wara l-waqfien ta' Herceptin.
English: No. patients with event (%)
Maltese: Numru ta' pazjenti blavveniment (%)
English: Herceptin plus docetaxel3
Maltese: Docetaxel3
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)
Maltese: - 5-fluorouracil fil-vini - 800 mg/m 2/jum bħala infużjoni kontinwa fil-vini fuq 5 ijiem, mogħtija kull 3 ġimgħat għal 6 ċikli (ġranet 1 sa 5 ta' kull ċiklu)
English: Comparison of trastuzumab PK data from Study M77004 in which women with HER2-positive MBC were treated concomitantly with Herceptin, paclitaxel and doxorubicin to trastuzumab PK data in studies where Herceptin 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 b'Herceptin, paclitaxel u doxorubicin fl-istess waqt ma' dejta PK dwar trastuzumab fi studji fejn Herceptin ingħata bħala monoterapija (H0649g) jew flimkien ma' anthracycline u cyclophosphamide jew paclitaxel (Studju H0648g), ma jissuġġerixxi l-ebda effett ta' doxorubicin u paclitaxel fuq il-farmakokinetika ta' trastuzumab.
English: • The other ingredients are recombinant human hyaluronidase (rHuPH20), L-histidine, L-histidine hydrochloride monohydrate, α,α-trehalose dihydrate, L-methionine, polysorbate 20, water for injections.
Maltese: • Is-sustanzi l-oħra huma hyaluronidase rikombinanti uman (rHuPH20), L-histidine, L-histidine hydrochloride monohydrate, α,α-trehalose dihydrate, L-methionine, polysorbate 20, ilma għallinjezzjonijiet.
English: Median months Overall Response Rate, % 34.5 % 47.3 % 1.70a (1.22, 2.38) 0.0017
Maltese: 3 % 1.70a (1.22, 2.38) 0.0017 Tul tar-Rispons, Xhur medjana
English: A total of 595 patients with HER2-positive, operable or locally advanced breast cancer (LABC) including inflammatory breast cancer received eight cycles of either Herceptin intravenous formulation or Herceptin subcutaneous formulation concurrently with chemotherapy (4 cycles of docetaxel, 75 mg/m2 intravenous infusion, followed by 4 cycles of FEC ([5-Fluorouracil, 500 mg/m2; epirubicin, 75 mg/m2; cyclophosphamide, 500 mg/m2 each intravenous bolus or infusion]), followed by surgery, and continued therapy with Herceptin intravenous formulation or Herceptin subcutaneous formulation as originally randomized for 10 additional cycles, for a total of one year of treatment.
Maltese: 75 mg/m2; cyclophosphamide, 500 mg/m kull wieħed bolus jew infużjoni fil-vini]), segwit minn kirurġija, u komplew it-terapija bil-formulazzjoni għall-għoti fil-vini ta' Herceptin jew bilformulazzjoni għall-għoti taħt il-ġilda ta' Herceptin kif oriġinarjament kienu randomized għal 10 ċikli addizzjonali, għal total ta' sena ta' kura.
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
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: - 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 3060 minutes repeated every 3 weeks for a total of six cycles
Maltese: - docetaxel fil-vini - 75 mg/m bħala infużjoni fil-vina fuq medda ta' siegħa, mogħti kull 3 ġimgħat għal 6 ċikli (f'ġurnata 2 ta' ċiklu 1, wara dan fl-ewwel ġurnata ta' kull ċiklu sussegwenti) 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: In the final population PK model, in addition to primary tumor 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: One 6 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film containing 5 mL of solution (600 mg of trastuzumab).
Maltese: Kunjett wieħed ta' 6 mL ta' ħġieġ ċar tip I b'tapp tal-lasktu butyl laminat b'kisja ta' fluoro-resin li fih 5 mL ta' soluzzjoni (600 mg ta' trastuzumab).
English: No. patients with event p=0.0008
Maltese: Numru ta' pazjenti blavveniment p=0.0008
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 Herceptin.
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 Herceptin.
English: Congestive heart failure (NYHA Class II-IV) is a common adverse reaction to Herceptin.
Maltese: II-IV) hija reazzjoni avversa komuni għal Herceptin.
English: - The NSABP B-31 and NCCTG N9831 studies that comprise the joint analysis were designed to investigate the clinical utility of combining Herceptin treatment with paclitaxel following AC chemotherapy, additionally the NCCTG N9831 study also investigated adding Herceptin 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 b'Herceptin tingħata flimkien ma' paclitaxel wara kimoterapija AC, barra dan l-istudju NCCTG N9831 investiga wkoll iż-żieda sekwenzjali ta' Herceptin ma' kimoterapija AC → P f'pazjenti b'EBC pożittiv għal HER2 wara kirurġija.
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: A population PK model with parallel linear and nonlinear elimination from the central compartment was constructed using pooled Herceptin SC and Herceptin IV PK data from the phase III study BO22227 to describe the observed PK concentrations following Herceptin IV and Herceptin SC administration in EBC patients.
Maltese: Kien mibni mudell tal-PK tal-popolazzjoni b'eliminazzjoni parallela lineari u mhux lineari millkompartiment ċentrali bl-użu ta' dejta PK miġbura dwar Herceptin SC u Herceptin IV mill-istudju BO22227 ta' fażi
English: The mean AUC0-21 days following the Cycle 7 dose was approximately 10 % higher with the Herceptin subcutaneous formulation as compared to the Herceptin intravenous formulation, with mean AUC values of 2268 µg/mL•day and 2056 µg/mL•day, respectively.
Maltese: L-AUC0-21 ġurnata medja wara d-doża ta' Ċiklu 7 kienet madwar 10 % ogħla bil-formulazzjoni għallgħoti taħt il-ġilda ta' Herceptin meta mqabbel mal-formulazzjoni għall-għoti fil-vini ta' Herceptin, b'valuri medji tal-AUC ta' 2268 µg/mL•kuljum u 2056 µg/mL•kuljum, rispettivament.
English: The pivotal trial BO22227 was designed to demonstrate non-inferiority of treatment with Herceptin subcutaneous formulation versus treatment with Herceptin intravenous formulation based on coprimary PK and efficacy endpoints (trastuzumab Ctrough at pre-dose Cycle 8, and pCR rate at definitive surgery, respectively) (See Section 5.1. of Herceptin subcutaneous formulation SmPC).
Maltese: BO22227 kienet maħsuba biex turi n-nuqqas ta' inferjorità ta' kura bil-formulazzjoni għall-għoti taħt il-ġilda ta' Herceptin kontra kura bil-formulazzjoni għall-għoti fil-vini ta' Herceptin ibbażat fuq punti finali ko-primarji tal-PK u tal-effikaċja (Ctrough ta' trastuzumab qabel id-doża ta' Ċiklu 8, u r-rata ta' pCR waqt kirurġija definittiva, rispettivament) (Ara Sezzjoni 5.1. tal-SmPC talformulazzjoni għall-għoti taħt il-ġilda ta' Herceptin).
English: Once transferred from the vial to the syringe the medicinal product is physically and chemically stable for 28 days at 2°C - 8°C and for 6 hours (cumulative time in the vial and the syringe) at ambient temperature (max. 30°C) in diffused daylight.
Maltese: Ladarba trasferit mill-kunjett għas-siringa l-prodott mediċinali huwa fiżikament u kimikament stabbli għal 28 jum f'temperatura ta' 2°C - 8°C u għal 6 sigħat (ħin kumulattiv fil-kunjett u s-siringa) f'temperatura ambjentali (mass.
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 %
English: The resulting solution contains approximately 21 mg/mL trastuzumab.
Maltese: Is-soluzzjoni li tirriżulta fiha madwar 21 mg/mL trastuzumab.
English: 12 months, the hazard ratio (HR) for disease free survival (DFS) was 0.54 (95 % CI 0.44, 0.67) which translates into an absolute benefit, in terms of a 2-year disease-free survival rate, of 7.6 percentage points (85.8 % versus 78.2 %) in favour of the Herceptin arm.
Maltese: Wara segwitu medjan ta' 12-il xahar, il-proporzjon ta' periklu (HR - hazard ratio) għas-sopravivenza mingħajr ilmarda (DFS - disease free survival) kien ta' 0.54 (CI ta' 95 % 0.44, 0.67) li huwa definit bħala benefiċċju assolut, f'termini ta' rata ta' sopravivenza mingħajr il-marda ta' sentejn, ta' 7.6 punti perċentwali (85.8 % kontra 78.2 %) favur il-grupp ikkurat b'Herceptin.
English: Hazard Ratio vs AC→P (95% CI) p-value
Maltese: Proporzjon ta' Periklu kontra AC→P (CI ta' 95 %) Valur p
English: Hazard Ratio vs AC→P (95 % CI) p-value
Maltese: Proporzjon ta' Periklu kontra AC→P (CI ta' 95%) valur p
English: Docetaxel was administered as follows:
Maltese: • Reazzjonijiet relatati mal-għoti:
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
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 IV segwita minn 6 mg/kg q3w jew 2 mg/kg q1w IV, rispettivament).
English: +Pleural effusion
Maltese: Effużjoni fil-plewra
English: Either of which was administered with: - cisplatin - 80 mg/m2 every 3 weeks for 6 cycles on day 1 of each cycle.
Maltese: It-tnejn ingħataw ma': - cisplatin - 80 mg/m kull 3 ġimgħat għal 6 ċikli fl-ewwel ġurnata ta' kull ċiklu.
English: Administration-related reactions (ARRs)/hypersensitivity reactions such as chills and/or fever, dyspnoea, hypotension, wheezing, bronchospasm, tachycardia, reduced oxygen saturation, respiratory distress, rash, nausea, vomiting and headache were seen in Herceptin clinical trials (see section 4.4).
Maltese: Reazzjonijiet relatati mal-għoti (ARRs - Administration related reactions)/reazzjonijiet ta' sensittività eċċessiva bħal tertir u/jew deni, qtugħ ta' nifs, pressjoni baxxa, tħarħir, bronkospażmu, takikardija, saturazzjoni ta' ossiġnu mnaqqsa, distress respiratorju, raxx, dardir, rimettar u uġigħ ta' ras kienu osservati fi provi kliniċi b'Herceptin (ara sezzjoni 4.4).
English: Table 1: Undesirable effects reported with intravenous Herceptin monotherapy or in combination with chemotherapy in pivotal clinical trials (N = 8386) and in post-marketing
Maltese: Tabella 1: Effetti mhux mixtieqa rrappurtati b'Herceptin fil-vini bħala monoterapija jew flimkien ma' kimoterapija fi provi kliniċi pivitali (N = 8386) u wara t-tqegħid fis-suq
English: Body weight and serum alanine aminotransferase (SGPT/ALT) showed a statistically significant influence on PK, however, simulations demonstrated that no dose adjustments are required in EBC patients.
Maltese: Piż tal-ġisem u alanine aminotransferase fis-serum (SGPT/ALT) urew influwenza statistikament sinifikanti fuq PK, madankollu, simulazzjonijiet urew li ma kinux meħtieġa aġġustamenti fid-doża f'pazjenti b'EBC.
English: By comparison of simulated serum trastuzumab concentrations after Herceptin monotherapy (4 mg/kg loading/2 mg/kg q1w IV) 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' Herceptin (doża għolja tal-bidu ta' 4 mg/kg/2 mg/kg q1w IV) 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: Patients with MBC who have previously received anthracyclines are also at risk of cardiac dysfunction with Herceptin treatment, although the risk is lower than with concurrent use of Herceptin and anthracyclines.
Maltese: Pazjenti b'MBC li qabel kienu rċevew anthracyclines ukoll huma f'riskju ta' disfunzjoni kardijaka b'kura b'Herceptin, għalkemm ir-riskju huwa inqas milli bl-użu fl-istess waqt ta' Herceptin u anthracyclines.
English: 95 % CI 0.67, 0.86).
Maltese: [CI ta' 95%: 0.61;1.45]).
English: A: doxorubicin; C: cyclophosphamide; P: paclitaxel; D: docetaxel; Carb: carboplatin; H: trastuzumab
Maltese: A: doxorubicin; C: cyclophosphamide; P: paclitaxel; D: docetaxel; Carb: carboplatin; H: trastuzumab CI = intervall ta' kunfidenza * Fil-ħin tal-analiżi definittiva ta' DFS.
English: Serious reactions to intravenous Herceptin have been treated successfully with supportive therapy such as oxygen, beta-agonists, and corticosteroids.
Maltese: Reazzjonijiet serji kienu kkurati b'suċċess b'terapija ta' appoġġ bħal ossiġnu, agonisti beta, u kortikosterojdi.
English: • Tumour lysis syndrome (a group of metabolic complications occurring after cancer treatment characterized 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).