FrancophonIA/ELRC3.0 huggingface dataset:
English: 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 talparametru 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), Tabella 15 (stat fiss), u Tabella 16 (parametri PK).
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 talarterja koronarja, CHF, LVEF ta' < 55%, xjuħija.
English: The vial contains 420 mg trastuzumab.
Maltese: Il-kunjett fih 420 mg trastuzumab.
English: Herzuma is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC):
Maltese: Herzuma huwa indikat għall-kura ta' pazjenti adulti b'kanċer bikri tas-sider (EBC - early breast cancer) pożittiv għal HER2:
English: Primary efficacy analysis DFS hazard ratios (95% CI) p-value p<0.0001
Maltese: Proporzjonijiet ta' periklu talanaliżi ta' Segwitu fit-tul taleffikaċja ta' DFS (CI ta' 95%) valur p p < 0.0001
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: Tel: +385 1 6595 777
Maltese: Oktal Pharma d.o.o. Tel: +385 1 6595 777
English: In the final population PK model, in addition to primary tumour type, body-weight, serum aspartate aminotransferase and albumin were identified as 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:  Hypersensitivity to trastuzumab, murine proteins, or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għal trastuzumab, proteini tal-ġrieden, jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: At the time of the analysis a total of 349 randomised patients had died: 182 patients (62.8%) in the control arm and 167 patients (56.8%) in the treatment arm.
Maltese: Fiż-żmien tal-analiżi total ta' 349 pazjent li kienu ntgħażlu b'mod każwali mietu: 182 pazjent (62.8%) fil-grupp ta' kontroll u 167 pazjent (56.8%) fil-grupp ta' kura.
English: It is not known whether trastuzumab can affect reproductive capacity.
Maltese: Mhux magħruf jekk trastuzumab jistax jaffettwa l-kapaċità riproduttiva.
English: A: doxorubicin; C: cyclophosphamide; P: paclitaxel; H: trastuzumab * At median duration of follow up of 1.8 years for the patients in the AC→P arm and 2.0 years for patients in the AC→PH arm ** p value for OS did not cross the pre-specified statistical boundary for comparison of AC→PH vs. AC→P
Maltese: A: doxorubicin; C: cyclophosphamide; P: paclitaxel; H: trastuzumab * F'tul ta' żmien medjan ta' segwitu ta' 1.8 snin għall-pazjenti fil-grupp ta' AC→P u sentejn għall-pazjenti filgrupp ta' AC→PH ** Valur p għal OS ma qabisx il-limitu statistiku speċifikat minn qabel għall-paragun ta' AC→PH kontra AC→P
English: Monitoring may help to identify patients who develop cardiac dysfunction.
Maltese: Deskrizzjoni ta' reazzjonijiet avversi magħżula Disfunzjoni kardijaka
English: In the pivotal trials (H0648g, M77001), paclitaxel or docetaxel was administered the day following the first dose of trastuzumab (for dose, see the Summary of Product Characteristics (SmPC) for paclitaxel or docetaxel) and immediately after the subsequent doses of trastuzumab if the preceding dose of trastuzumab was well tolerated.
Maltese: Fil-provi pivitali (H0648g, M77001), paclitaxel jew docetaxel ingħata l-għada tal-ewwel doża ta' trastuzumab (għad-doża, ara s-Sommarju tal-Karatteristiċi tal-Prodott (SmPC - Summary of Product Characteristics) għal paclitaxel jew docetaxel) u immedjatament wara d-dożi ta' wara ta' trastuzumab jekk id-doża preċedenti ta' trastuzumab kienet ittollerata tajjeb.
English: Volume (mL) = Body weight (kg) x dose (8 mg/kg for loading or 6 mg/kg for maintenance) 21 (mg/mL, concentration of reconstituted solution)
Maltese: Volum (mL) = Piż tal-ġisem (kg) x doża (8 mg/kg għad-doża ogħla tal-bidu jew 6 mg/kg għad-doża ta' manteniment) 21 (mg/mL, konċentrazzjoni tas-soluzzjoni rikostitwita)
English: Patients who receive anthracyclines after stopping Herzuma may possibly be at increased risk of cardiac dysfunction.
Maltese: Pazjenti li jirċievu anthracyclines wara l-waqfien ta' Herzuma jistgħu jkunu f'riskju akbar ta' disfunzjoni kardijaka.
English: Solutions of Herzuma 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 30ºC.
Maltese: Soluzzjonijiet ta' Herzuma għall-infużjoni ġol-vini huma fiżikament u kimikament stabbli għal 24 siegħa f'temperaturi li ma jaqbżux 30ºC, f'boroż tal-polyvinylchloride, polyethylene jew polypropylene li fihom soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) sodium chloride.
English: Serious reactions 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: The results of these simulations indicate that at least 95% of patients will reach concentrations that are <1 μg/mL (approximately 3% of the population predicted Cmin,ss, or about 97% washout) by 7 months.
Maltese: Ir-riżultati ta' dawn is-simulazzjonijiet jindikaw li millinqas 95% tal-pazjenti se jilħqu konċentrazzjonijiet li huma < 1 μg/mL (madwar 3% ta' Cmin,ss imbassra tal-popolazzjoni, jew eliminazzjoni kompluta ta' madwar 97%) wara 7 xhur.
English: - in combination with neoadjuvant chemotherapy followed by adjuvant Herzuma 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' Herzuma, għallmard avanzat lokalment (inkluż infjammatorju) jew tumuri b'dijametru ta' > 2 cm (ara sezzjonijiet 4.4 u 5.1).
English: Orion Pharma AB Tel: + 46 8 623 64 40
Maltese: Tel: + 46 8 623 64 40
English: Each carton contains 1 vial of powder.
Maltese: Kull kartuna fiha kunjett wieħed bi trab.
English: An absolute benefit of 13 percentage points in favour of the trastuzumab arm was estimated in terms of 3-year event-free survival rate (65% versus 52%).
Maltese: Benefiċċju assolut ta' 13-il punt perċentwali favur il-grupp ta' trastuzumab kien stmat f'termini ta' rata ta' sopravivenza mingħajr avveniment ta' 3 snin (65% kontra 52%).
English: Acute respiratory distress syndrome Not known Bronchospasm
Maltese: Sindrome ta' distress respiratorju akut
English:  Paclitaxel 175 mg/m administered 3-weekly for 4 cycles,
Maltese: • Paclitaxel 175 mg/m2 mogħti darba kull 3 ġimgħat għal 4 ċikli, li kien segwit minn
English: All candidates for treatment with Herzuma, 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'Herzuma, 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: In the BCIRG 006 study, HER2 positive, EBC was defined as either lymph node positive or high risk node negative patients with no (pN0) lymph node involvement, and at least 1 of the following factors: tumour size greater than 2 cm, estrogen receptor and progesterone receptor negative, histological and/or nuclear grade 2 - 3, or age < 35 years.
Maltese: Fl-istudju BCIRG 006, EBC pożittiv għal HER2 kien definit bħala pożittiv għall-glandoli limfatiċi jew pazjenti negattivi għall-glandoli b'riskju għoli bl-ebda (pN0) involviment tal-glandoli limfatiċi, u millinqas wieħed mill-fatturi li ġejjin: daqs tat-tumur akbar minn 2 ċm, negattivi għar-riċetturi tal-estrogen u riċetturi tal-progesterone, grad istoloġiku u/jew nukleari ta' 2 - 3, jew età ta' < 35 sena).
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: 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) 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: Hazard ratio versus AC→P (95% CI)
Maltese: Proporzjon ta' periklu kontra AC→P (CI ta' 95%)
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 bi trastuzumab ġol-vini bħala monoterapija jew flimkien ma' kimoterapija fi provi kliniċi pivitali (N = 8386) u wara t-tqegħid fis-suq
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: Herzuma is given as an intravenous infusion (“drip”) directly into your veins.
Maltese: Herzuma jingħata bħala infużjoni ġol-vini (“drip”) direttament ġol-vini tiegħek.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTURI
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 avanzat tal-istonku biex jistudja lfarmakokinetika ta' capecitabine u cisplatin meta jintużaw ma' jew mingħajr trastuzumab.
English: Comparison of PK results from two Phase II studies (BO15935 and M77004) and one Phase III study (H0648g) in which patients were treated concomitantly with trastuzumab and paclitaxel and two Phase II studies in which trastuzumab was administered as monotherapy (W016229 and MO16982), in women with HER2-positive MBC indicates that individual and mean trastuzumab trough serum concentrations varied within and across studies but there was no clear effect of the concomitant administration of paclitaxel on the pharmacokinetics of trastuzumab.
Maltese: II li fihom trastuzumab ingħata bħala monoterapija (W016229 u MO16982), f'nisa b'MBC pożittiv għal HER2 jindika li l-inqas konċentrazzjonijiet individwali u medji fis-serum ta' trastuzumab varjaw fi ħdan u bejn l-istudji iżda ma kien hemm l-ebda effett ċar tal-għoti flimkien ta' paclitaxel fuq il-farmakokinetika ta' trastuzumab.
English: Patients who had previously received anthracycline-based adjuvant chemotherapy were treated with paclitaxel (175 mg/m infused over 3 hours) with or without trastuzumab.
Maltese: Pazjenti li qabel kienu rċevew kimoterapija awżiljarja bbażata fuq anthracycline kienu kkurati b'paclitaxel (175 mg/m mogħti bħala infużjoni fuq medda ta' 3 sigħat) bi jew mingħajr trastuzumab.
English: Trastuzumab washout period was assessed following q1w or q3w intravenous administration using the population PK model.
Maltese: Il-perjodu biex Trastuzumab jiġi eliminat kompletament kien evalwat wara għoti q1w jew q3w ġolvini bl-użu tal-mudell PK tal-popolazzjoni.
English: Medical Logistics Ltd. Tel: +356 2755 9990
Maltese: Tel: +356 2755 9990
English: In the pivotal trial BO22227, trastuzumab was administered concurrently with neoadjuvant chemotherapy that contained four cycles of epirubicin (cumulative dose 300 mg/m2); at a median follow-up exceeding 70 months, the incidence of cardiac failure/congestive cardiac failure was 0.3% in the trastuzumab intravenous arm.
Maltese: BO22227, trastuzumab ingħata flimkien ma' kimoterapija neoawżiljarja li kien fiha erba' ċikli ta' epirubicin (doża kumulattiva ta' 300 mg/m2); waqt segwitu medjan jaqbeż 70 xahar, linċidenza ta' insuffiċjenza tal-qalb/insuffiċjenza konġestiva tal-qalb kienet ta' 0.3% fil-grupp ta' trastuzumab fil-vini.
English: th th
Maltese: Rogħda
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: Herzuma is not recommended for anyone under the age of 18 years.
Maltese: Herzuma mhux rakkomandat għall-persuni b'età inqas minn 18-il sena.
English: In the neoadjuvant setting, the experience of concurrent administration of trastuzumab and low dose anthracycline regimen is limited (see section 4.4).
Maltese: l-esperjenza tal-għoti ta' trastuzumab flimkien ma' kors ta' doża baxxa ta' anthracycline hija limitata (ara sezzjoni 4.4).
English: Hazard ratio vs AC→P (95% CI) p-value
Maltese: Proporzjon ta' periklu kontra AC→P (CI ta' 95%) valur p
English: By comparison of simulated serum trastuzumab concentrations after trastuzumab monotherapy (4 mg/kg loading/2 mg/kg q1w intravenous) and observed serum concentrations in Japanese women with HER2-positive MBC (study JP16003) no evidence of a PK effect of concurrent administration of docetaxel on the pharmacokinetics of trastuzumab was found.
Maltese: Permezz ta' paragun ta' konċentrazzjonijiet simulati ta' trastuzumab fis-serum wara monoterapija ta' trastuzumab (doża għolja tal-bidu ta' 4 mg/kg/2 mg/kg q1w ġol-vini) u konċentrazzjonijiet osservati fis-serum f'nisa Ġappuniżi b'MBC pożittiv għal HER2 (studju JP16003) ma nstabet l-ebda evidenza ta' effett PK tal-għoti fl-istess waqt ta' docetaxel fuq il-farmakokinetika ta' trastuzumab.
English: It is estimated that approximately 40% of patients who are treated with trastuzumab will experience some form of infusion-related reaction.
Maltese: Huwa stmat li madwar 40% tal-pazjenti kkurati bi trastuzumab ikollhom xi forma ta' reazzjoni relatata mal-infużjoni.
English: • The other ingredients are L-histidine hydrochloride, L-histidine, α,α-trehalose dihydrate, polysorbate 20.
Maltese: • Is-sustanzi mhux attivi l-oħra huma L-histidine hydrochloride, L-histidine, ,-trehalose dihydrate, polysorbate 20.
English: Each vial of Herzuma is reconstituted with 7.2 mL of sterile water for injection (not supplied).
Maltese: Kull kunjett ta' Herzuma huwa rikostitwit b'7.2 mL ta' ilma għall-injezzjoni sterili (mhux ipprovdut).
English: 150 mg Unopened vial
Maltese: 150 mg Kunjett mhux miftuħ
English: Data from a single-arm study JP16003 of trastuzumab (4 mg/kg intravenous loading dose and 2 mg/kg intravenous weekly) and docetaxel (60 mg/m intravenous) in Japanese women with HER2-positive MBC, suggested that concomitant administration of trastuzumab had no effect on the single dose pharmacokinetics of docetaxel.
Maltese: Dejta minn studju bi grupp wieħed JP16003 ta' trastuzumab (doża għolja tal-bidu ta' 4 mg/kg ġolvini u 2 mg/kg ġol-vini kull ġimgħa) u docetaxel (60 mg/m ġol-vini) f'nisa Ġappuniżi b'MBC pożittiv għal HER2, issuġġeriet li l-għoti fl-istess waqt ta' trastuzumab ma kellu l-ebda effett fuq ilfarmakokinetika ta' doża waħda ta' docetaxel.
English:  you have metastatic gastric cancer with high levels of HER2, when it is in combination with the other cancer medicines capecitabine or 5-fluorouracil and cisplatin.
Maltese: • inti jkollok kanċer metastatiku tal-istonku b'livelli għolja ta' HER2, fejn jiġi kombinat mal-mediċini l-oħra għall-kanċer capecitabine jew 5-fluorouracil u cisplatin.
English: Death (OS event) No. patients with event p=0.0024
Maltese: Mewt (avveniment OS) Numru ta' pazjenti bl-avveniment p = 0.0024
English: Herzuma and anthracyclines should not be given concurrently in combination in the MBC setting.
Maltese: Herzuma u anthracyclines m'għandhomx jingħataw fl-istess waqt flimkien f'sitwazzjoni ta' MBC.
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 [EFSevent free survival]) u s-sigurtà determinati mill-okkorrenza ta' reazzjonijiet relatati mal-għoti (ARRsadministration related reactions) ta' trastuzumab fil-vini
English: Sepsis
Maltese: Norge
English: Herzuma 420 mg powder for concentrate for solution for infusion trastuzumab
Maltese: Herzuma 420 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: Herzuma 150 mg powder for concentrate for solution for infusion trastuzumab
Maltese: Herzuma 150 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: fever, dyspnoea, hypotension, wheezing, bronchospasm, tachycardia, reduced oxygen saturation, respiratory distress, rash, nausea, vomiting and headache (see section 4.4).
Maltese: Ir-reazzjonijiet jinkludu, sirdat, deni, qtugħ ta' nifs, pressjoni baxxa, tħarħir, bronkospażmu, takikardija, saturazzjoni ta' ossiġnu mnaqqsa, distress respiratorju, raxx, tqalligħ, rimettar, u uġigħ ta' ras (ara sezzjoni 4.4).
English: 22014 Incheon REPUBLIC OF KOREA
Maltese: REPUBBLIKA TAL-KOREA
English: Tel: + 372 6 644 550
Maltese: Orion Pharma Eesti OÜ Tel: + 372 6 644 550
English: In the NSABP B-31 and NCCTG N9831 studies, trastuzumab was administered in combination with paclitaxel, following AC chemotherapy.
Maltese: Fl-istudji NSABP B-31 u NCCTG N9831 trastuzumab ingħata flimkien ma' paclitaxel, wara kimoterapija AC.
English: Strong complete, basolateral or lateral membranous reactivity in ≥ 10% of tumour cells
Maltese: Reattività qawwija, kompluta, bażolaterali jew laterali filmembrana f' ≥ 10% taċ-ċelluli tat-tumur.
English: Distant recurrence No. patients with event p=0.0008
Maltese: Metastasi Numru ta' pazjenti bl-avveniment p = 0.0008
English: Median TTP (months) (95% CI)
Maltese: Sopravivenza medjana (xhur) (CI ta' 95%)
English: Herzuma is not genotoxic.
Maltese: Dawn ġeneralment huma temporanji.
English: Study MO16982: loading dose 6 mg/kg weekly x 3; followed by 6 mg/kg 3-weekly schedule 3.
Maltese: Studju WO16229: doża ogħla tal-bidu ta' 8 mg/kg, segwita minn kors ta' 6 mg/kg kull 3 ġimgħat Studju MO16982: doża ogħla tal-bidu ta' 6 mg/kg fil-ġimgħa x 3; segwita minn kors ta' 6 mg/kg kull 3 ġimgħat
English: The final OS results from the joint analysis of studies NSABP B-31 and NCCTG N9831 are summarised in Table 8 below:
Maltese: Ir-riżultati finali ta' OS mill-analiżi konġunta tal-istudji NSABP B-31 u NCCTG N9831 huma miġbura fil-qosor f'Tabella 8 taħt:
English: 1) Using a sterile syringe, slowly inject 7.2 mL of water for injections in the vial containing the lyophilised Herzuma, directing the stream into the lyophilised cake.
Maltese: 1) Permezz ta' siringa sterili, injetta bil-mod 7.2 mL ta' ilma għall-injezzjonijiet fil-kunjett li fih
English: Distant recurrence No. patients with event p<0.0001
Maltese: Numru ta' pazjenti bl-avveniment p < 0,0001
English: Hot flush
Maltese: Wara d-dilwizzjoni
English: Patients with MBC who have previously received anthracyclines are also at risk of cardiac dysfunction with Herzuma treatment, although the risk is lower than with concurrent use of Herzuma and anthracyclines.
Maltese: Pazjenti b'MBC li qabel kienu rċevew anthracyclines ukoll huma f'riskju ta' disfunzjoni kardijaka b'kura b'Herzuma, għalkemm ir-riskju huwa inqas milli bl-użu fl-istess waqt ta' Herzuma u anthracyclines.
English: Tel: +34 93 700 2525
Maltese: Kern Pharma, S.L. Tel: +34 93 700 2525
English: In the neoadjuvant-adjuvant EBC study (BO22227), at a median follow-up exceeding 70 months, 10.1% (30/296) of patients treated with trastuzumab intravenous developed antibodies against trastuzumab.
Maltese: Sopravivenza mingħajr il-marda - Numru ta' pazjenti bl-avveniment 219 (12.9%) 127 (7.5%) 570 (33.6%) 471 (27.7%) - Numru ta' pazjenti mingħajr lavveniment
English: The rate of asymptomatic cardiac dysfunction was increased in the 2-year treatment arm (8.1% versus 4.6% in the 1-year treatment arm).
Maltese: Ir-rata ta' disfunzjoni kardijaka mingħajr sintomi żdiedet fil- grupp ta' kura ta' sentejn (8.1% kontra 4.6% fil-grupp ta' kura ta' sena waħda).
English: Time to steadystate
Maltese: Twissijiet u prekawzjonijiet
English: After reconstitution with sterile water for injection the reconstituted solution is physically and chemically stable for 7 days at 2ºC - 8ºC.
Maltese: Wara r-rikostituzzjoni b'ilma għall-injezzjoni sterili s-soluzzjoni rikostitwita hija fiżikament u kimikament stabbli għal 7 ijiem f'temperatura ta' 2ºC - 8ºC.
English: A volume overage of 4% ensures that the labelled dose of 150 mg can be withdrawn from each vial.
Maltese: Volum ta' 4% aktar jiżgura li d-doża mmarkata ta' 150 mg tkun tista' tittella' minn kull kunjett.
English: - capecitabine - 1000 mg/m orally twice daily for 14 days every 3 weeks for 6 cycles (evening of day 1 to morning of day 15 of each cycle)
Maltese: Kimoterapija ingħatat kif ġej: - capecitabine - 1000 mg/m orali darbtejn kuljum għal 14-il ġurnata kull 3 ġimgħat għal 6 ċikli (fil-għaxija tal-ewwel ġurnata sa fil-għodu ta' ġurnata 15 ta' kull ċiklu)
English: If possible, physicians should avoid anthracycline-based therapy for up to 7 months after stopping Herzuma.
Maltese: Jekk possibbli, it-tobba għandhom jevitaw terapija bbażata fuq anthracycline għal sa 7 xhur wara l-waqfien ta' Herzuma.
English: The appropriate amount of solution should be withdrawn from the vial and added to an infusion bag containing 250 mL of 0.9% sodium chloride solution.
Maltese: Il-ammont xieraq ta' soluzzjoni għandu jittella' mill-kunjett u jiżdied ma' borża tal-infużjoni li fiha 250 mL ta' soluzzjoni ta' 0.9% Sodium chloride.