FrancophonIA/ELRC3.0 huggingface dataset:
English: HER2 overexpression was determined at a central laboratory and defined as a score of 3+ by IHC or an ISH amplification ratio ≥2.0 in the trials outlined below.
Maltese: Espressjoni żejda ta' HER2 kienet determinata f'laboratorju ċentrali u definita bħala punteġġ ta' 3+ permezz ta' IHC jew proporzjon ta' amplifikazzjoni ta' ISH ta' ≥2.0 fil-provi deskritti hawn taħt.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Maltese: Jekk ma jintużax immedjatament, il-ħin u l-kondizzjonijiet ta' ħażna waqt l-użu qabel jingħata huma r-responsabbiltà ta' minn qed juża' l-prodott, u normalment m'għandhomx ikunu itwal minn 24 siegħa f'temperatura ta' 2 °C sa 8 °C, sakemm id-dilwizzjoni ma sseħħx taħt kondizzjonijiet asettiċi kkontrollati u validati.
English: Perjeta is given with other cancer treatments (trastuzumab andchemotherapy).
Maltese: Il-maġġoranza tal-avvenimenti kienu rrappurtati f'pazjenti ttrattati b'anthracycline.
English: APHINITY is a multicentre, randomised, double-blind, placebo-controlled Phase III trial conducted in 4804 patients with HER2-positive early breast cancer who had their primary tumour excised prior to randomisation.
Maltese: III, b'aktar minn ċentru wieħed, randomised, double blind, ikkontrollata bil-plaċebo li twettqet fuq 4804 pazjenti b'kanċer bikri tas-sider pożittiv għal HER2 li kellhom it-tumuri primarji tagħhom imneħħija permezz ta' kirurġija qabel randomisation.
English: Difference in pCR rates
Maltese: GĦAMLA KWALITATTIVA
English: The cancer has not spread to other parts of the body and treatment is going to be given before surgery takes place (treatment before surgery is called neoadjuvant therapy) The cancer has not spread to other parts of the body and treatment is going to be given after surgery (treatment after surgery is called adjuvant therapy)
Maltese: Il-kanċer ma jkunx infirex għal partijiet oħra tal-ġisem u l-kura tkun se tingħata wara lkirurġija (kura wara l-kirurġija hija msejħa terapija adjuvant)
English: Stomatitis
Maltese: UŻU
English: decline of at least 10% points from baseline and to <50% was <1% (0.6% of Perjeta-treated patients vs 0.3% of placebo-treated patients).
Maltese: III jew IV) bi tnaqqis fl-LVEF ta' mill-inqas 10% mil-linja bażi u għal <50% kienet <1% (0.6% tal-pazjenti ttrattati b'Perjeta vs 0.3% tal-pazjenti ttrattati bil-plaċebo).
English: The highest incidence of diarrhoea (all Grades) was reported during the targeted therapy+taxane chemotherapy period (61.4% of patients in the Perjeta arm vs. 33.8% of patients in the placebo arm).The incidence of diarrhoea was much lower after chemotherapy cessation, affecting
Maltese: L-ogħla inċidenza ta' dijarea (il-Gradi kollha) kienet irrappurtata waqt il-perjodu ta' terapija mmirata+kimoterapija b'taxane (61.4% tal-pazjenti fil-grupp ta' Perjeta vs. 33.8% tal-pazjenti fil-grupp tal-plaċebo).
English: Perjeta in combination with trastuzumab and docetaxel CLEOPATRA (WO20698) is a multicentre, randomised, double-blind, placebo-controlled phase III clinical trial conducted in 808 patients with HER2-positive metastatic or locally recurrent unresectable breast cancer.
Maltese: III b'aktar minn ċentru wieħed, randomised, double-blind u kkontrollata bil-plaċebo li twettqet fuq 808 pazjent b'kanċer tas-sider li ma jistax jitneħħa, pożittiv għal HER2, metastatiku jew rikorrenti lokalment.
English: Perjeta recognises and attaches to a target called “human epidermal growth factor receptor 2” (HER2).
Maltese: Perjeta jagħraf u jeħel ma' mira msejħa “riċettur tal-fattur ta' tkabbir epidermali uman 2” (HER2).
English: Cough Epistaxis Dyspnoea
Maltese: Fil-prova pivitali
English: In the NEOSPHERE trial, 8.4% of patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel experienced febrile neutropenia compared with 7.5% of patients treated with trastuzumab and docetaxel.
Maltese: Fil-prova NEOSPHERE, 8.4% tal-pazjenti kkurati b'Perjeta, trastuzumab u docetaxel neoadjuvant kellhom newtropenija bid-deni meta mqabbel ma' 7.5% tal-pazjenti kkurati b'trastuzumab u docetaxel.
English: The majority of patients had node-positive (63%) and/or hormone receptor-positive disease (64%), and were Caucasian (71%).
Maltese: Il-maġġoranza tal-pazjenti kellhom marda bi glandoli pożittivi (63%) u/jew marda pożittiva għar-riċettur tal-ormoni (64%), u kienu Kawkażi (71%).
English: There was one case of symptomatic LVD in the Perjeta and trastuzumab-treated group.
Maltese: Kien hemm każ wieħed ta' LVD sintomatika fil-grupp ikkurat b'Perjeta u trastuzumab.
English: Unopened vial
Maltese: Komuni Ħafna
English: Patients who have received prior anthracyclines or prior radiotherapy to the chest area may be at higher risk of LVEF declines.
Maltese: Pazjenti li rċevew anthracyclines qabel jew radjuterapija flerja tas-sider qabel jistgħu jkunu f'riskju ogħla ta' tnaqqis fl-LVEF.
English: Secondary endpoints included the assessment of patient-reported global health status, role and physical function, and treatment symptoms using the EORTC QLQ-C30 and EORTC QLQ-BR23 questionnaires.
Maltese: Punti finali sekondarji jinkludu l-valutazzjoni tal-istat ta' saħħa globali, rwol u funzjoni fiżika, u sintomi tat-trattament irrappurtati mill-pazjent bl-użu tal-kwestjonarji EORTC QLQ-C30 u EORTC QLQ-BR23. Fl-analiżi tar-riżultati rrappurtati mill-pazjent, differenza ta' 10 punti kienet meqjusa klinikament sinifikanti.
English: While pertuzumab alone inhibited the proliferation of human tumour cells, the combination of pertuzumab and trastuzumab significantly augmented antitumour activity in HER2-overexpressing xenograft models.
Maltese: Filwaqt li waħdu pertuzumab jinibixxi l-proliferazzjoni ta' ċelluli umani tat-tumur, il-kombinazzjoni ta' pertuzumab u trastuzumab żiedet b'mod sinifikanti l-attività kontra t-tumur f'mudelli ta' xenograft b'espressjoni żejda ta' HER2.
English: In the TRYPHAENA trial, febrile neutropenia occurred in 17.1% of patients treated with neoadjuvant Perjeta + TCH, and 9.3% of patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel following FEC.
Maltese: Fil-prova TRYPHAENA, newtropenija bid-deni seħħet fi 17.1% tal-pazjenti kkurati b'Perjeta + TCH neoadjuvant, u f'9.3% tal-pazjenti kkurati b'Perjeta, trastuzumab u docetaxel neoadjuvant wara FEC.
English: In cynomolgus monkeys, weekly intravenous administration of pertuzumab at doses up to 150 mg/kg/dose was generally well tolerated.
Maltese: F'xadini cynomolgus, għoti fil-vini ta' kull ġimgħa ta' pertuzumab b'dożi sa 150 mg/kg/doża ġeneralment kienu ttollerati tajjeb.
English: A multicenter, open-label, single-arm study of pertuzumab in combination with trastuzumab and a taxane in first line treatment of patients with HER2- positive advanced (metastatic or locally recurrent) breast cancer
Maltese: Studju b'aktar minn ċentru wieħed, open-label, bi grupp wieħed ta' pertuzumab flimkien ma' trastuzumab u taxane fil-kura primarja ta' pazjenti b'kanċer tas-sider avvanzat (metastatiku jew rikorrenti lokalment) pożittiv għal HER2
English: Secondary efficacy endpoints were overall survival (OS), PFS (investigator-assessed), objective response rate (ORR), duration of response, and time to symptom progression according to the FACT B Quality of Life questionnaire.
Maltese: Punti finali sekondarji tal-effikaċja kienu sopravivenza globali (OS - overall survival), PFS (stmata mill-investigatur), rata ta' rispons oġġettiv (ORR
English: The primary endpoint of the BERENICE trial is cardiac safety in the neoadjuvant period of the trial.
Maltese: Il-punt finali primarju tal-prova BERENICE huwa s-sigurtà kardijaka fil-perjodu neoadjuvant talprova.
English: In the pivotal trial CLEOPATRA in metastatic breast cancer, diarrhoea occurred in 68.4% of Perjetatreated patients and 48.7% of placebo-treated patients (see section 4.4).
Maltese: CLEOPATRA f'kanċer metastatiku tas-sider, dijarea seħħet f'68.4% tal-pazjenti kkurati b'Perjeta u f'48.7% tal-pazjenti kkurati bil-plaċebo.
English: Pertuzumab and trastuzumab were administered intravenously (see section 4.2) every 3 weeks starting on Day 1 of the first taxane-containing cycle, for a total of 52 weeks (up to 18 cycles) or until recurrence, withdrawal of consent or unmanageable toxicity.
Maltese: Perjeta u trastuzumab ingħataw fil-vini (ara sezzjoni 4.2) kull 3 ġimgħat b'bidu f'Jum 1 tal-ewwel ċiklu li fih taxane, għal total ta' 52 ġimgħa (sa 18-il ċiklu) jew sa rikorrenza, irtirar tal-kunsens jew tossiċità li ma tistax tiġi mmaniġġjata.
English: Patients should have a pre-treatment left ventricular ejection fraction (LVEF) of ≥ 50%.
Maltese: Il-pazjenti għandu jkollhom porzjon imbuttat 'il barra mill-ventriklu tax-xellug (LVEF - left ventricular ejection fraction) qabel it-trattament ta' ≥ 50%.
English: One 14 ml vial of concentrate contains 420 mg of pertuzumab at a concentration of 30 mg/ml.
Maltese: Kunjett wieħed ta' 14 ml fih 420 mg ta' pertuzumab f'konċentrazzjoni ta' 30 mg/ml.
English: Peripheral s ensory neuropathy
Maltese: .9 Doża eċċessiva
English: Patients' median LVEF at baseline was 65.0% (range 50% - 88%) in both groups.
Maltese: Total ta' 43% tal-pazjenti fiż-żewġ gruppi ta' kura kienu rċevew radjuterapija. LVEF medjan tal-pazjenti fil-linja bażi kienet ta' 65.0% (firxa 50% - 88%) fiż-żewġ gruppi.
English: The primary endpoint of the study was invasive disease-free survival (IDFS), defined as the time from randomisation to first occurrence of ipsilateral local or regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, or death from any cause.
Maltese: Il-punt finali primarju tal-istudju kien sopravivenza mingħajr marda invażiva (IDFS - invasive diseasefree survival), definit bħala ż-żmien minn randomisation sal-ewwel okkorrenza ta' rikorrenza ta' kanċer tas-sider ipsilaterali lokali jew reġjonali invażiv, rikorrenza f'post ieħor, kanċer tas-sider kontralaterali invażiv jew mewt minn kwalunkwe kawża.
English: No overall differences in efficacy and safety of Perjeta were observed in patients ≥65 and <65 years of age with the exception of diarrhoea, which had an increased incidence in patients ≥65 years of age.
Maltese: Ma kienu osservati l-ebda differenzi globali fl-effikaċja u s-sigurtà ta' Perjeta f'pazjenti b'età ta' ≥65 u <65 sena bl-eċċezzjoni ta' dijarea, li kellha inċidenza akbar f'pazjenti b'età ta' ≥65 sena.
English: • If you get any side effects, talk to your doctor or nurse.
Maltese: • Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib, jew lill-infermier tiegħek.
English: Diarrhoea
Maltese: Disġewsja
English: With doses of 15 mg/kg and higher, intermittent mild treatment-associated diarrhoea was noted.
Maltese: B'dożi ta' 15 mg/kg u ogħla, kienet innutata dijarea ħafifa u intermittenti assoċjata mal-kura.
English: Complete response (CR) Partial Response (PR) Stable disease (SD) Progressive disease (PD)
Maltese: Pazjenti li rrispondew*** 95% CI għal ORR Rispons komplut (CR) Rispons parzjali (PR) Marda Stabbli (SD) Marda progressiva (PD)
English: No pharmacokinetic (PK) interactions were observed between pertuzumab and trastuzumab, or between pertuzumab and docetaxel in a sub-study of 37 patients in the randomised, pivotal trial CLEOPATRA in metastatic breast cancer.
Maltese: Ma kienux osservati interazzjonijiet farmakokinetiċi (PK) bejn pertuzumab u trastuzumab, jew bejn pertuzumab u docetaxel f'sottostudju ta' 37 pazjent fil-prova randomised, pivitali
English: Table 2 Summary of ADRs in patients treated with Perjeta in clinical trials^, and in the Postmarketing setting†
Maltese: Tabella 2 Sommarju ta' ADRs f'pazjenti kkurati b'Perjeta fi provi kliniċi^, u fl-ambjent ta' wara t-Tqegħid fis-suq††
English: Febrile neutropenia occurred in 13.7% of Perjeta-treated patients and 7.6% of placebo-treated patients.
Maltese: Newtropenija bid-deni seħħet fi 13.7% tal-pazjenti kkurati b'Perjeta u f'7.6% tal-pazjenti ikkurati bilplaċebo.
English: Perjeta should not be given to patients under the age of 18 years because there is no information on how it works in this age group.
Maltese: Perjeta m'għandux jingħata lill-pazjenti b'età inqas minn 18-il sena peress li m'hemmx informazzjoni dwar kif jaħdem f'dan il-grupp ta' età.
English: Sequential use of Perjeta (in combination with trastuzumab and a taxane) has been evaluated following the epirubicin or doxorubicin component of many anthracycline-based regimens in the APHINITY and BERENICE studies.
Maltese: L-użu sekwenzjali ta' Perjeta (flimkien ma' trastuzumab u taxane) ġie evalwat wara l-komponent ta' epirubicin jew doxorubicin ta' ħafna korsijiet ibbażati fuq anthracycline fl-istudji APHINITY u BERENICE.
English: Feeling dizzy
Maltese: Pazjenti anzjani
English: At Caesarean section on GD100, oligohydramnios, decreased relative lung and kidney weights and microscopic evidence of renal hypoplasia consistent with delayed renal development were identified in all pertuzumab dose groups.
Maltese: Maċ-ċesarja f'GD100, fil-gruppi kollha ddożati b'pertuzumab kien osservat tnaqqis filfluwidu tal-borqom, tnaqqis fil-piż relattiv tal-pulmun u tal-kliewi u evidenza mikroskopika ta' ipoplażija tal-kliewi konsistenti ma' żvilupp ittardjat tal-kliewi.
English: Cytokine release syndrome°°
Maltese: Mediċini oħra u Perjeta
English: The 840 mg loading dose of pertuzumab should be re-administered as a 60 minute infusion, followed by a maintenance dose of 420 mg IV administered every 3 weeks thereafter.
Maltese: Id-doża għolja tal-bidu ta' 840 mg pertuzumab għandha terġa' tingħata bħala infużjoni ta' 60 minuta segwita minn doża ta' manteniment ta' 420 mg IV mogħtija kull 3 ġimgħat minn hemm 'il quddiem.
English: In the NEOSPHERE trial, the incidence of NCI-CTCAE v.3 Grade 3-4 neutropenia was 74.5% in patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel compared with 84.5% in patients treated with trastuzumab and docetaxel, including 50.9% and 60.2% Grade 4 neutropenia, respectively.
Maltese: 5% f'pazjenti kkurati b'trastuzumab u docetaxel, inkluż 50.9% u 60.2% newtropenija ta' Grad 4, rispettivament.
English: trastuzumab and docetaxel-treated group (7.5%) compared to the trastuzumab and docetaxel-treated group (1.9%).
Maltese: Fil-prova APHINITY, kienet irrappurtata inċidenza ogħla ta' dijarea fil-grupp ittrattat b'Perjeta (71.2%) meta mqabbel mal-grupp tal-plaċebo (45.2%).
English: Assess LVEF prior to initiation of Perjeta and at regular intervals during treatment with Perjeta (e.g. once during neoadjuvant treatment and every 12 weeks in the adjuvant or metastatic setting) to ensure that LVEF is within normal limits.
Maltese: Evalwa LVEF qabel il-bidu ta' Perjeta u f'intervalli regolari waqt il-kura b'Perjeta (eż. darba waqt trattament neoadjuvant u kull 12-il ġimgħa f'ambjent adjuvant jew metastatiku) sabiex jiġi żgurat li lLVEF huwa fil-limitu tan-normal.
English: Renal impairment
Maltese: Pazjenti b'indeboliment renali
English: The most common infusion reactions (≥ 1.0%) in the Perjeta-treated group were pyrexia, chills, fatigue, headache, asthenia, hypersensitivity and vomiting.
Maltese: Ir-reazzjonijiet għall-infużjoni l-aktar komuni (≥ 1.0%) fil-grupp ikkurat b'Perjeta kienu deni, sirdat, għeja, uġigħ ta' ras, astenja, sensittività eċċessiva u rimettar.
English: • 4 cycles of AC or epirubicin and cyclophosphamide (EC), followed by 3 or 4 cycles of docetaxel or 12 cycles of weekly paclitaxel
Maltese: • 4 ċikli ta' AC jew epirubicin u cyclophosphamide (EC), segwiti minn 3 jew 4 ċikli ta'
English: Perjeta will be stored by the health professionals at the hospital or clinic.
Maltese: Perjeta se jiġi maħżun minn professjonisti fil-qasam mediku fi sptar jew klinika.
English: Tumour lysis syndrome†
Maltese: lisi tattumur†
English: p-value (Log-Rank test, stratified1) 3 year event-free rate2 [95% CI]
Maltese: 5] Sopravivenza Mingħajr il-Marda (DFS) Numru (%) ta' pazjenti b'avveniment HR [CI ta' 95%]
English: Dysgeusia
Maltese: Soluzzjoni dilwita
English: Tumour lysis syndrome (a condition which may happen when cancer cells die quickly, causing changes in blood levels of minerals and metabolites shown in a blood test).
Maltese: Sindrome ta' lisi tal-tumur (kondizzjoni li tista' sseħħ meta ċ-ċelluli tal-kanċer imutu malajr, li tikkawża bidliet fil-livelli ta' minerali u metaboliti osservati f'test tad-demm).
English: Based on the pharmacological actions of HER2-targeted agents and anthracyclines, the risk of cardiac toxicity might be expected to be higher with concomitant use of Perjeta and anthracyclines than with sequential use.
Maltese: Ibbażat fuq l-azzjonijiet farmakoloġiċi ta' sustanzi mmirati lejn HER2 u anthracyclines, ir-riskju ta' tossiċità kardijaka jista' jkun mistenni li jkun ogħla b'użu ta' Perjeta flimkien ma' anthracyclines milli b'użu sekwenzjali.
English: pCR rates were similar in patients with operable and locally advanced disease.
Maltese: Ir-rati ta' pCR kienu simili fil-pazjenti b'marda operabbli u marda avanzata lokalment.
English: The primary endpoint of the study was progression-free survival (PFS) as assessed by an independent review facility (IRF) and defined as the time from the date of randomisation to the date of disease progression or death (from any cause) if the death occurred within 18 weeks of the last tumour assessment.
Maltese: Il-punt finali primarju tal-istudju kien sopravivenza mingħajr progressjoni (PFS) kif evalwata minn faċilità ta' stima indipendenti (IRF) u definita bħala ż-żmien mid-data ta' meta kienu randomised saddata ta' progressjoni tal-marda jew mewt (minn kwalunkwe kawża) jekk il-mewt seħħet fi żmien 18-il ġimgħa mill-aħħar valutazzjoni tat-tumur.
English: th
Maltese: Kft.
English: The median duration of the longest episode was 18 days in Perjeta-treated patients and 8 days in placebotreated patients.
Maltese: It-tul medjan tal-itwal episodju kien ta' 18-il ġurnata fil-pazjenti kkurati b'Perjeta u ta' 8 ijiem fil-pazjenti kkurati bil-plaċebo.
English: The fixed dose of 600mg trastuzumab SC should be administered as soon as possible.
Maltese: Id-doża fissa ta' 600 mg trastuzumab SC għandha tingħata malajr kemm jista' jkun.
English: In NEOSPHERE, 8.3% of Asian patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel experienced febrile neutropenia compared with 4.0% of Asian patients treated with neoadjuvant trastuzumab and docetaxel.
Maltese: F'NEOSPHERE, 8.3% tal-pazjenti Asjatiċi kkurati b'Perjeta, trastuzumab u docetaxel neoadjuvant kellhom newtropenija bid-deni meta mqabbel ma' 4.0% tal-pazjenti Asjatiċi kkurati b'trastuzumab u docetaxel neoadjuvant.
English: 80.6% of placebo-treated patients had recovered at the data cutoff.
Maltese: 6% tal-pazjenti ttrattati bil-plaċebo kienu rkupraw meta waqfet tinġabar id-data.
English: FEC Perjeta+ Trastuzumab
Maltese: trastuzumab + kimoterapija
English: In conclusion, administration of Pertuzumab may cause Infusion Related Reactions (IRR) and hypersensitivity/anaphylaxis reactions that can be associated with fatal outcome and the Product Information should be updated to reflect such outcome.
Maltese: Bħala konklużjoni, l-għoti ta' Pertuzumab jista' jikkawża Reazzjonijiet Relatati mal-Infużjoni (IRR - Infusion Related Reactions) u reazzjonijiet ta' sensittività eċċessiva/anafilassi li jistgħu jkunu assoċjati ma' eżitu fatali u l-Informazzjoni tal-Prodott għandha tiġi aġġornata biex tirrifletti tali eżitu.
English: In repeated dose toxicity studies in cynomolgus monkeys, no definitive conclusions could be drawn on the adverse effect on male reproductive organs.
Maltese: Fi studji dwar l-effett tossiku minn dożi ripetuti f'xadini cynomolgus, ma setgħux jintlaħqu konklużjonijiet definittivi dwar l-effett negattiv fuq l-organi riproduttivi maskili.
English: Patients were randomised to receive one of three neoadjuvant regimens prior to surgery as follows:
Maltese: Meta mogħti ma' Perjeta rrakkomandazzjoni hija li tiġi segwita skeda ta' 3 ġimgħat għal trastuzumab mogħti bħala:
English: In the pivotal trial CLEOPATRA, the majority of patients in both treatment groups experienced at least one leucopenic event (63.0% of patients in the Perjeta-treated group and 58.3% of patients in the placebo-treated group), of which the majority were neutropenic events (see section 4.4).
Maltese: CLEOPATRA, il-maġġoranza tal-pazjenti fiż-żewġ gruppi ta' kura kellhom millinqas avveniment lewkopeniku wieħed (63.0% tal-pazjenti fil-grupp ikkurat b'Perjeta u 58.3% talpazjenti fil-grupp ikkurat bil-plaċebo), li l-maġġoranza tagħhom kienu avvenimenti newtropeniċi.
English: BERENICE is a non-randomized, open-label, multicentre, multinational, Phase II trial conducted in 401 patients with HER2-positive locally advanced, inflammatory, or early-stage breast cancer (with primary tumours > 2cm in diameter or node-positive disease).
Maltese: II li twettqet fuq 401 pazjent b'kanċer tas-sider pożittiv għal HER2, avanzat lokalment u infjammatorju jew b'kanċer tas-sider fi stadju bikri (b'tumuri primarji b'dijametru ta' > 2 cm jew marda pożittiva għall-glandoli).
English: (ejection fraction decrease according to NCI-CTCAE v.4) was 7% in the group treated with dose dense AC followed by Perjeta plus trastuzumab and paclitaxel and 3.5% in the group treated with FEC
Maltese: L-inċidenza ta' LVD mhux sintomatika (tnaqqis fl-ejection fraction skont NCI-CTCAE v.4) kienet ta' 7% fil-grupp ittrattat b'dose dense AC segwit minn Perjeta flimkien ma' trastuzumab u paclitaxel u ta' 3.5% fil-grupp ittrattat b'FEC segwit minn Perjeta flimkien ma' trastuzumab u docetaxel.
English: Anaemia
Maltese: Mijalġja
English: No statistically significant differences were found between the two treatment groups in Health Related Quality of Life as assessed by FACT-B TOI-PFB scores.
Maltese: Ma nstabu l-ebda differenzi statistikament sinifikanti bejn iż-żewġ gruppi ta' kura fil-Kwalità tal-Ħajja
English: Compared with published data for similar regimens without pertuzumab, high pCR rates were observed in all 3 treatment arms (see Table 4).
Maltese: Meta mqabbel ma' data ppublikata għall-korsijiet simili mingħajr pertuzumab, kienu osservati rati għolja ta' pCR fit-3 gruppi ta' kura kollha (ara Tabella 4).
English: Perjeta contains the active substance pertuzumab and is used to treat adult patients with breast cancer when:
Maltese: Perjeta fih is-sustanza attiva pertuzumab u jintuża biex jikkura pazjenti adulti b'kanċer tas-sider meta:
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreeed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Diarrhoea symptoms returned to baseline after HER2 therapy in the Perjetaarm.
Maltese: Is-sintomi ta' dijarea reġgħu lura għallinja bażi wara terapija għal HER2 fil-grupp ta' Perjeta.
English: Perjeta is administered as an intravenous infusion.
Maltese: Perjeta huwa konċentrat ta' soluzzjoni għall-infużjoni.
English: Table 6 Efficacy results in subgroups by nodal status and hormone receptor status1 Population
Maltese: Tabella 6 Riżultati tal-effikaċja f'sottogruppi skont l-istat tal-glandoli u l-istat tar-riċettur talormoni1
English: Patients were treated with Perjeta and trastuzumab until disease progression, withdrawal of consent or unmanageable toxicity.
Maltese: Il-pazjenti kienu kkurati b'Perjeta u trastuzumab sal-progressjoni tal-marda, irtirar tal-kunsens jew tossiċità li ma tistax tiġi mmaniġġata.
English: The safety of Perjeta has been evaluated in more than 6,000 patients in Phase I, II, and III trials in patients with various malignancies and predominantly treated with Perjeta in combination with other antineoplastic agents.
Maltese: Is-sigurtà ta' Perjeta ġiet evalwata f'iktar minn 6,000 pazjent fi provi ta' Fażi I, II u III f'pazjenti b'diversi tumuri malinni u li kienu kkurati primarjament b'Perjeta flimkien ma' sustanzi antineoplastiċi oħra.