FrancophonIA/ELRC3.0 huggingface dataset:
English: Death (OS event) No. patients with event p = 0.0024
Maltese: Mewt (avveniment OS) Numru ta' pazjenti blavveniment p = 0.0024
English: Death (OS event): No. patients with event (%)
Maltese: Mewt (avveniment OS): Numru ta' pazjenti blavveniment (%)
English: Table 7 Summary of efficacy results from the joint analysis of the NSABP B-31 and NCCTG N9831 trials at the time of the definitive DFS analysis*
Maltese: Tabella 7 Sommarju tar-riżultati tal-effikaċja mill-analiżi konġunta tal-provi NSABP B-31 u NCCTG N9831 fil-ħin tal-analiżi definittiva ta' DFS*:
English: Each vial contains either; o 150 mg trastuzumab that has to be dissolved in 7.2 mL of water for injections, or o 420 mg trastuzumab that has to be dissolved in 20 mL of water for injections.
Maltese: Kull kunjett fih jew; o 150 mg trastuzumab li għandu jiġi mdewweb f'7.2 mL ta' ilma għall-injezzjonijiet, jew o 420 mg trastuzumab li għandu jiġi mdewweb f'20 mL ta' ilma għall-injezzjonijiet.
English: Pre-switching rates (Cycles 1-4) for serious adverse events, grade 3 adverse events and treatment discontinuations due to adverse events were low (< 5 %) and similar to post-switching rates (Cycles 58).
Maltese: Rati ta' bidliet minn qabel (Ċikli 1-4) minħabba avvenimenti avversi serji, avvenimenti avversi ta' grad 3 u twaqqif tal-kura minħabba avvenimenti avversi kienu baxxi (<5%) u simili għal rati wara l-bidla (Ċikli 5-8).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1341/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1341/001
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq issit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: Solutions of Ogivri for intravenous infusion are physically and chemically stable in polyvinylchloride, polyethylene or polypropylene bags containing sodium chloride 9 mg/mL (0.9 %) solution for injection for 24 hours at temperatures not exceeding 30°C.
Maltese: Soluzzjonijiet ta' Ogivri għall-infużjoni fil-vini huma fiżikament u kimikament stabbli għal 24 siegħa f'temperaturi li ma jaqbżux 30°C, f'boroż tal-polyvinylchloride, polyethylene jew polypropylene li fihom soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) sodium chloride.
English: • Hypersensitivity to the active substance, murine proteins, or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva, proteini tal-ġrieden, jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: EBC is defined as non-metastatic primary invasive carcinoma of the breast.
Maltese: EBC huwa definit bħala karċinoma primarja, invażiva, mhix metastatika tas-sider.
English: Ogivri 150 mg powder for concentrate for solution for infusion 15 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film containing 150 mg of trastuzumab.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Ogivri 150 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Kunjett ta' 15 mL magħmul minn ħġieġ ċar tip I b'tapp tal-gomma butyl laminat b'kisja ta' fluororesin li fih 150 mg ta' trastuzumab.
English: Trastuzumab loading dose should be administered as a 90-minute intravenous infusion.
Maltese: Id-doża ogħla tal-bidu ta' trastuzumab għandha tingħata bħala infużjoni fil-vini fuq medda ta' 90 minuta.
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 (ARRs - administration related reactions) ta' trastuzumab fil-vini.
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 ilfarmakokinetika ta' trastuzumab.
English: Mylan Healthcare B.V. Tel: +31 (0)20 426 3300
Maltese: Tel: +31 (0)20 426 3300
English: Upper respiratory tract infection
Maltese: +Insuffiċjenza respiratorja
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1341/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1341/002
English: • increased muscle tone or tension (hypertonia)
Maltese: +Pulmonite (pneumonia)
English: Haemorrhoids
Maltese: Iperkalemija
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 sodium chloride 9 mg/mL (0.9%) solution for injection.
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' soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/mL (0.9%).
English: HER2 over expression should be detected using an immunohistochemistry (IHC)-based assessment of fixed tumour blocks; HER2 gene amplification should be detected using in situ hybridisation using either SISH or FISH on fixed tumour blocks.
Maltese: Espressjoni żejda ta' HER2 għandha tiġi osservata permezz ta' valutazzjoni ibbażata fuq immunoistokimika (IHC - immunohistochemistry) ta' blokki fissi tat-tumur; amplifikazzjoni tal-ġene HER2 għandha tiġi osservata bl-użu ta'in situ hybridisation bl-użu ta' SISH jew FISH ta' blokki fissi tat-tumur.
English: Ogivri 150 mg powder for concentrate for solution for infusion This medicine contains 115.2 mg sorbitol in each vial.
Maltese: Ogivri 150 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Din il-mediċina fiha 115.
English: These include, but are not limited to, pulmonary infiltrates, acute respiratory distress syndrome, pneumonia, pneumonitis, pleural effusion, respiratory distress, acute pulmonary oedema and respiratory insufficiency (see section 4.4).
Maltese: Dawn jinkludu, iżda mhumiex limitati għal, infiltrati pulmonari, sindrome ta' distress respiratorju akut, pulmonite (pneumonia u pneumonitis), effużjoni fil-plewra, distress respiratorju, edima pulmonari akuta u insuffiċjenza respiratorja (ara sezzjoni 4.4).
English: - Study BO16348 was designed to compare one and two years of three-weekly trastuzumab treatment versus observation in patients with HER2 positive EBC following surgery, established chemotherapy and radiotherapy (if applicable).
Maltese: Studju BO16348 kien maħsub biex iqqabbel kura bi trastuzumab kull tliet ġimgħat għal sena u sentejn ma' osservazzjonijiet f'pazjenti b'EBC pożittiv għal HER2 wara kirurġija, kimoterapija stabbilita u radjuterapija (jekk applikabbli).
English: Weak to moderate complete, basolateral or lateral membranous reactivity in ≥ 10 % of tumour cells
Maltese: 2+ Reattività ħafifa sa moderata, kompluta, bażolaterali jew laterali fil-membrana f'≥10% taċ-ċelluli tat-tumur
English: The bioactivity of D7D and the clinical impact of the elevation of this metabolite were unclear.
Maltese: Il-bioattività ta' D7D u l-impatt kliniku tal-elevazzjoni ta' dan il-metabolit ma kinux ċari.
English: Infections and infestations Infection
Maltese: Infezzjonijiet u infestazzjonijiet Infezzjoni
English: Patients treated with trastuzumab are at increased risk for developing CHF (New York Heart Association [NYHA] Class II-IV) or asymptomatic cardiac dysfunction.
Maltese: Pazjenti kkurati bi trastuzumab huma f'riskju akbar għall-iżvilupp ta' CHF (New York Heart Association [NYHA] Klassi
English: Ogivri is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC): - following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section 5.1) - following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel - in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.
Maltese: Ogivri huwa indikat għall-kura ta' pazjenti adulti b'kanċer bikri tas-sider (EBC - early breast cancer) pożittiv għal HER2: wara kirurġija, kimoterapija (neo-awżiljarja jew awżiljarja) u radjuterapija (jekk applikabbli) (ara sezzjoni 5.1) wara kimoterapija awżiljarja b'doxorubicin u cyclophosphamide, flimkien ma' paclitaxel jew docetaxel flimkien ma' kimoterapija awżiljarja li tikkonsisti minn docetaxel u carboplatin. flimkien ma' kimoterapija neoawżiljarja segwita minn terapija awżiljarja ta' Ogivri, għall-mard avvanzat lokalment (inkluż infjammatorju) jew tumuri b'dijametru ta' >2 cm (ara sezzjonijiet 4.4 u
English: ** Median duration of long term follow-up for the Joint Analysis clinical studies was 8.3 years (range: 0.1 to 12.1) for the AC→PH arm and 7.9 years (range: 0.0 to 12.2) for the AC→P arm; Median duration of long term follow-up for the BCIRG 006 study was 10.3 years in both the AC→D arm (range: 0.0 to 12.6) arm and the DCarbH arm (range: 0.0 to 13.1), and was 10.4 years (range: 0.0 to 12.7) in the AC→DH arm
Maltese: It-tul medjan ta' segwitu fittul għall-istudju BCIRG 006 kien ta' 10.3 snin kemm fil-grupp ta' AC→D (firxa: 0.0 sa 12.6) kif ukoll filgrupp 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: Distant recurrence No. patients with event p < 0.0001
Maltese: Numru ta' pazjenti blavveniment p < 0.0001
English: Study MO22982 investigated switching between the trastuzumab intravenous and trastuzumab subcutaneous formulation with a primary objective to evaluate patient preference for either intravenous or the subcutaneous route of trastuzumab administration.
Maltese: Studju MO22982 investiga bidla bejn il-formulazzjoni ta' trastuzumab għall-għoti fil-vini u trastuzumab għall-għoti taħt il-ġilda bi skop primarju li tiġi evalwata l-preferenza tal-pazjenti għall għoti ta' trastuzumab fil-vini jew taħt il-ġilda.
English: After reconstitution with sterile water for injections, the reconstituted solution is physically and chemically stable for 48 hours at 2°C-8°C.
Maltese: Wara r-rikostituzzjoni b'ilma għall-injezzjoni sterili s-soluzzjoni rikostitwita hija fiżikament u kimikament stabbli għal 48 siegħa f'temperatura ta' 2°C-8°C.
English: Always keep this medicine in the closed original pack at a temperature of 2ºC - 8 ºC in a refrigerator.
Maltese: Dejjem żomm din il-mediċina fil-pakkett oriġinali magħluq f'temperatura ta' 2°C - 8°C fil-friġġ.
English: The primary endpoint was overall survival which was defined as the time from the date of randomisation to the date of death from any cause.
Maltese: Il-punt finali primarju kien issopravivenza globali li kienet definita bħala ż-żmien mid-data ta' randomization sad-data tal-mewt minn kwalunkwe kawża.
English: Lung infiltration
Maltese: Fil-prova pivitali
English: Post-hoc exploratory analysis with DFS and symptomatic cardiac events
Maltese: II - IV) jew disfunzjoni kardijaka mhux sintomatika.
English: Ogivri 150 mg powder for concentrate for solution for infusion Ogivri 420 mg powder for concentrate for solution for infusion trastuzumab
Maltese: Ogivri 150 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Ogivri 420 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: Strong complete, basolateral or lateral membranous reactivity in ≥ 10 % of tumour cells
Maltese: 3+ Reattività qawwija, kompluta, bażolaterali jew laterali filmembrana f'≥10% taċ-ċelluli tat-tumur.
English: In study MO16432, trastuzumab (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, trastuzumab (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: Doxorubicin 60 mg/m² u paclitaxel 150 mg/m², mogħtija darba kull 3 ġimgħat għal 3 ċikli,
English: Ogivri should only be used in patients with metastatic or EBC whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay (see sections 4.4 and 5.1).
Maltese: Huwa meħtieġ ittestjar għal HER2 qabel tinbeda t-terapija (ara sezzjonijiet 4.4 u 5.1).
English: Other infusion-related symptoms are: feeling sick (nausea), vomiting, pain, increased muscle tension and shaking, headache, dizziness, breathing difficulties, wheezing, high or low blood pressure, heart rhythm disturbances (palpitations, heart fluttering or irregular heart beat), swelling of the face and lips, rash and feeling tired.
Maltese: Sintomi oħra relatati malinfużjoni huma: tħossok imdardar (tqalligħ), rimettar, uġigħ, żieda fit-tensjoni tal-muskoli u tregħid, uġigħ ta' ras, sturdament, diffikultajiet respiratorji, tħarħir, pressjoni għolja jew baxxa, disturbi firritmu tal-qalb (palpitazzjonijiet, ritmu mhux normali tal-qalb jew taħbit irregolari tal-qalb), nefħa talwiċċ u x-xufftejn, raxx u tħossok għajjien/a.
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 filgrupp ta' kura ta' sentejn (8.1% kontra 4.6% fil-grupp ta' kura ta' sena waħda).
English: Data from study JP16003, a single-arm study of trastuzumab (4 mg/kg intravenous loading dose and 2 mg/kg intravenous weekly) and docetaxel (60 mg/m2 intravenous) in Japanese women with HER2
Maltese: Dejta minn studju JP16003, studju bi grupp wieħed ta' trastuzumab (doża għolja tal-bidu ta' 4 mg/kg ġol-vini u 2 mg/kg ġol-vini kull ġimgħa) u docetaxel (60 mg/m² 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: A volume overage of 4.8 % ensures that the labelled dose of 420 mg can be withdrawn from each vial.
Maltese: Volum ta' 4.8% aktar jiżgura li d-doża mmarkata ta' 420 mg tkun tista' tittella' minn kull kunjett.
English: In patients who receive anthracycline-containing chemotherapy further monitoring is recommended, and should occur yearly up to 5 years from the last administration of trastuzumab, or longer if a continuous decrease of LVEF is observed.
Maltese: F'pazjenti li jirċievu kimoterapija li fiha anthracycline huwa rakkomandat aktar monitoraġġ, u dan għandu jseħħ kull sena sa 5 snin wara l-aħħar għoti ta' trastuzumab, jew aktar jekk jiġi osservat tnaqqis kontinwu ta' LVEF.
English: The rate was highest in patients who were administered trastuzumab concurrently with a taxane (2.0 %).
Maltese: Ir-rata kienet l-ogħla f'pazjenti li ngħataw trastuzumab flimkien ma' taxane (2.0%).
English: Chills
Maltese: Murliti
English: Signs and symptoms of cardiac dysfunction such as dyspnoea, orthopnoea, increased cough, pulmonary oedema, S3 gallop, or reduced ventricular ejection fraction, have been observed in patients treated with trastuzumab (see section 4.4).
Maltese: Sinjali u sintomi ta' disfunzjoni kardijaka bħal qtugħ ta' nifs, qtugħ ta' nifs waqt li wieħed ikun mindud, żieda fis-sogħla, edima pulmonari, gallop S3, jew porzjon imbuttat ‘il barra mill-ventriklu imnaqqsa, ikunu osservati f'pazjenti kkurati bi trastuzumab (ara sezzjoni 4.4).
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: Għandek 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: After reconstitution, 1 mL concentrate contains 21 mg of trastuzumab.
Maltese: Wara r-rikostituzzjoni, 1 mL ta' konċentrat ikun fih 21 mg ta' trastuzumab.
English: or - intravenous 5-fluorouracil - 800 mg/m2/day as a continuous intravenous infusion over 5 days,
Maltese: 5-fluorouracil fil-vini - 800 mg/m²/jum bħala infużjoni kontinwa fil-vini fuq 5 ijiem, mogħtija kull 3 ġimgħat għal 6 ċikli (ġranet 1 sa 5 ta' kull ċiklu)
English: Ogivri 420 mg powder for concentrate for solution for infusion Each 420 mg vial of Ogivri is reconstituted with 20 mL of sterile water for injections (not supplied).
Maltese: Kull kunjett ta' 420 mg ta' Ogivri huwa rikostitwit b'20 mL ta' ilma għall-injezzjonijiet sterili (mhux ipprovdut).
English: Trastuzumab and anthracyclines should not be given concurrently in combination in the MBC setting.
Maltese: Trastuzumab u anthracyclines m'għandhomx jingħataw fl-istess waqt flimkien f'sitwazzjoni ta' MBC.
English: Ogivri 150 mg contains 115.2 mg sorbitol in each vial.
Maltese: Ogivri 150 mg fih 115.
English: In addition, a post-hoc exploratory analysis was performed on the data sets from the joint analysis (JA) NSABP B-31/NCCTG N9831* and BCIRG006 clinical studies combining DFS events and symptomatic cardiac events and summarised in Table 11:
Maltese: Barra dan, saret analiżi esploratorja post-hoc fuq is-settijiet ta' dejta mill-analiżi konġunta (JA - joint analysis) tal-istudji kliniċi NSABP B-31/NCCTG N9831* u BCIRG006 li jikkombinaw avvenimenti ta' DFS u avvenimenti sintomatiċi tal-qalb li huma miġbura fil-qosor f'Tabella 11:
English: Children and adolescents Ogivri is not recommended for anyone under the age of 18 years.
Maltese: Tfal u adolexxenti Ogivri mhux rakkomandat għall-persuni b'età inqas minn 18-il sena.
English: Hazard Ratio vs AC→D (95 % CI) p-value
Maltese: Proporzjon ta' Periklu kontra AC→D (CI ta' 95%) valur p
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: 1% (30/296) tal-pazjenti kkurati bi trastuzumab fil-vini żviluppaw antikorpi kontra trastuzumab.
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: Table 15 Population predicted steady state PK exposure values (median with 5th - 95th percentiles)for trastuzumab intravenous dosing regimens in MBC, EBC and AGC patients
Maltese: Tabella 15 Valuri mbassra tal-esponiment PK tal-popolazzjoni fi stat fiss (medjan b'595
English: Interstitial lung disease
Maltese: Infezzjoni tal-ġilda
English: Renal and urinary disorders Renal disorder
Maltese: Disturbi fil-kliewi u fis-sistema urinarja
English: Ogivri 420 mg powder for concentrate for solution for infusion One vial contains 420 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity and ion exchange chromatography including specific viral inactivation and removal procedures.
Maltese: Ogivri 420 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Kunjett wieħed fih 420 mg ta' trastuzumab, antikorp monoklonali
English: If you have hereditary fructose intolerance (HFI), a rare genetic disorder, you must not receive this medicine.
Maltese: Jekk inti għandek intolleranza ereditarja għal fructose (hereditary fructose intolerance - HFI), disturb ġenetiku rari, inti m'għandekx tingħata din il-mediċina.
English: - capecitabine - 1000 mg/m2 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/m² orali darbtejn kuljum għal 14-il ġurnata kull 3 ġimgħat għal 6 ċikli (filgħaxija tal-ewwel ġurnata sa filgħodu ta' ġurnata 15 ta' kull ċiklu) jew
English: 21 (mg/mL, concentration of reconstituted solution) The appropriate amount of solution should be withdrawn from the vial and added to an infusion bag containing 250 mL of sodium chloride 9 mg/mL (0.9 %) solution for injection.
Maltese: L-ammont xieraq ta' soluzzjoni għandu jittella' mill-kunjett u jiżdied ma' borża tal-infużjoni li fiha 250 mL soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/mL (0.9%).
English: Weekly dosing in metastatic breast cancer The efficacy results from the monotherapy and combination therapy studies are summarised in Table
Maltese: Riżultati tal-effikaċja mill-istudji mhux komparattivi ta' monoterapija u ta' terapija kombinata
English: Median Survival (months) (95 %CI)
Maltese: Sopravivenza medjana (xhur) (CI ta' 95%)
English: Ogivri is a biosimilar medicinal product.
Maltese: Ogivri huwa prodott mediċinali bijosimili.
English: Subsequent trastuzumab maintenance doses (weekly regimen: 2 mg/kg; three-weekly regimen 6 mg/kg respectively) should be administered 7 days or 21 days later according to the weekly or three-weekly schedules respectively.
Maltese: 6 mg/kg, rispettivament) għandhom jingħataw 7 ijiem jew 21 jum wara skont il-programmi ta' darba fil-ġimgħa jew ta' darba kull tliet ġimgħat, rispettivament.
English: The addition of trastuzumab to paclitaxel chemotherapy also resulted in a 37 % decrease in the risk of death.
Maltese: Iż-żieda ta' trastuzumab ma' kimoterapija b'paclitaxel irriżultat ukoll fi tnaqqis ta' 37% fir-riskju ta' mewt.
English: In study BO16348, after a median follow-up of 8 years the incidence of severe CHF (NYHA Class III & IV) in the trastuzumab 1 year treatment arm was 0.8 %, and the rate of mild symptomatic and asymptomatic left ventricular dysfunction was 4.6 %.
Maltese: III u IV) fil-grupp ta' kura bi trastuzumab għal sena waħda kienet ta' 0.8%, u r-rata ta' disfunzjoni ħafifa tal-ventrikolu tax-xellug bis-sintomi u bla sintomi kienet ta' 4.6%.
English: No reactivity or membranous reactivity in < 10 % of tumour cells
Maltese: L-ebda reattività jew reattività fil-membrana f'<10% taċċelluli tat-tumur
English: • shingles
Maltese: Ngħas
English: Ogivri is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC): - as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease.
Maltese: Ogivri huwa indikat għall-kura ta' pazjenti adulti b'kanċer metastatiku tas-sider (MBC - metastatic breast cancer) pożittiv għal HER2:
English: Most patients who developed CHF or asymptomatic cardiac dysfunction in pivotal trials improved with standard CHF treatment consisting of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) and a beta-blocker.
Maltese: Jekk tiżviluppa insuffiċjenza sintomatika tal-qalb waqt terapija bi trastuzumab, għandha tiġi kkurata bi prodotti mediċinali standard għal CHF. Il-biċca l-kbira tal-pazjenti li żviluppaw CHF jew disfunzjoni kardijaka bla sintomi fil-provi pivitali marru għall-aħjar b'kura standard għal CHF li tikkonsisti minn inibitur tal-enzima li tittrasforma lill-angiotensin (ACE - angiotensin-converting enzyme) jew imblokkatur tar-riċettur ta' angiotensin (ARB - angiotensin receptor blocker) u imblokkatur tarriċetturi beta.
English: Orthopnoea
Maltese: Ortopnija
English: Pericardial effusion
Maltese: Disturbi fid-dwiefer
English: Death (OS event): No. patients with event p < 0.0001
Maltese: Mewt (avveniment OS): Numru ta' pazjenti blavveniment p = 0.014**