FrancophonIA/ELRC3.0 huggingface dataset:
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 mill inqas 95% tal-pazjenti se jilħqu konċentrazzjonijiet li huma <1 μg/mL (madwar 3% ta' Cmin,ssimbassra tal-popolazzjoni, jew eliminazzjoni kompluta ta' madwar 97%) wara 7 xhur.
English: MBC EBC Table 15 Population predicted steady state PK exposure values (median with 5th - 95th percentiles) for trastuzumab intravenous infusion dosing regimens in MBC, EBC and AGC patients tumour type N Cmin,ss* Regimen Primary (µg/mL)
Maltese: MBC EBC Tabella 15 Valuri mbassra tal-esponiment PK tal-popolazzjoni fl-istat fiss (medjan b'5 - 95
English: Neoplasm progression
Maltese: Progressjoni ta' neoplażma
English: After a median follow-up of 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 trastuzumab arm.
Maltese: Wara segwitu medjan ta' 12-il xahar, il-proporzjon ta' periklu (HR - hazard ratio) għas-sopravivenza mingħajr il-marda (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'trastuzumab.
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: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1241/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/17/1241/001
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'
English: DFS analysis was also performed at the final analysis of OS from the joint analysis of studies NSABP B-31 and NCCTG N9831.
Maltese: Analiżi ta' DFS twettqet ukoll fl-analiżi finali ta' OS mill-analiżi konġunta tal-istudji NSABP B31 u NCCTG N9831.
English: In the neoadjuvant setting, the experience of concurrent administration of trastuzumab and low-dose anthracycline regimen is limited (see section 4.4).
Maltese: anthracycline hija limitata (ara sezzjoni 4.4).
English: + 7.2 mL
Maltese: Kunjett ta' 150 mg + 7.2 mL
English: Each vial contains either: 150 mg trastuzumab that has to be dissolved in 7.2 mL of water for injection, or 420 mg trastuzumab that has to be dissolved in 20 mL of water for injection.
Maltese: - 150 mg trastuzumab li għandu jiġi mdewweb f'7.2 mL ta' ilma għall-injezzjoni, jew - 420 mg trastuzumab li għandu jiġi mdewweb f'20 mL ta' ilma għall-injezzjoni.
English: During pregnancy:
Maltese: Waqt it-tqala:
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 b'trastuzumab kull tliet ġimgħat għal sena u sentejn ma' osservazzjonijiet f'pazjenti b'EBC pożittiv għal HER2 wara kirurġija,
English: Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488 medicinskinfo@merck.com
Maltese: Τel: +46 77 5700488 medicinskinfo@merck.com
English: Amongst the most serious and/or common adverse reactions reported in Ontruzant usage to date are cardiac dysfunction, infusion-related reactions, haematotoxicity (in particular neutropenia), infections and pulmonary adverse reactions.
Maltese: Fost l-aktar reazzjonijiet avversi serji u/jew komuni rrappurtati sal-lum waqt l-użu ta' Ontruzant hemm disfunzjoni kardijaka, reazzjonijiet relatati mal-infużjoni, tossiċità ematoloġika (b'mod partikolari newtropenija), infezzjonijiet u reazzjonijiet pulmonari avversi.
English: Pharmacokinetic data from studies BO15935 and M77004 in women with HER2-positive MBC suggested that exposure to paclitaxel and doxorubicin (and their major metabolites 6-α hydroxyl-paclitaxel, POH, and doxorubicinol, DOL) was not altered in the presence of trastuzumab (8 mg/kg or 4 mg/kg loading dose as an intravenous infusion followed by 6 mg/kg q3w or 2 mg/kg q1w infusion, respectively).
Maltese: Dejta farmakokinetika minn studji BO15935 u M77004 fuq nisa b'MBC pożittiv għal HER2 issuġġeriet li esponiment għal paclitaxel u doxorubicin (u l-metaboliti prinċipali tagħhom
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 80.9%) in favour of the AC→DH (trastuzumab) arm and 4.6 percentage points (85.5% versus 80.9% ) in favour of the DCarbH (trastuzumab) arm compared to AC→D.
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: In one of the 3 pivotal studies conducted in which a median follow-up of 5.5 years was available (BCIRG006) a continuous increase in the cumulative rate of symptomatic cardiac or LVEF events was observed in patients who were administered trastuzumab concurrently with a taxane following anthracycline therapy up to 2.37% compared to approximately 1% in the two comparator arms (anthracycline plus cyclophosphamide followed by taxane and taxane, carboplatin and trastuzumab).
Maltese: (BCIRG006) kienet osservata żieda kontinwa fir-rata kumulattiva ta' avvenimenti kardijaċi sintomatiċi jew avvenimenti ta' LVEF sa 2.37% f'pazjenti li ngħataw trastuzumab flimkien ma'
English: • anaphylactic reactions (serious allergic reaction)
Maltese: • reazzjonijiet anafilattiċi (reazzjoni allerġika serja)
English: following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section 5.1).
Maltese: wara kirurġija, kimoterapija (neo-awżiljarja jew awżiljarja) u radjuterapija (jekk applikabbli)
English: Instructions for reconstitution:
Maltese: TA' EĊĊIPJENTI Eċċipjenti:
English: At 8 years, the survival rate was estimated to be 86.9% in the AC→PH arm and 79.4% in the AC→P arm, an absolute benefit of 7.4% (95% CI 4.9%, 10.0%).
Maltese: benefiċċju assolut ta' 7.4% (CI ta' 95% 4.9%, 10.
English: Distant recurrence No. patients with event p<0.0001
Maltese: Numru ta' pazjenti bl-avveniment p<0.0001
English: AC→DH (vs. AC→D) (BCIRG 006)
Maltese: AC→DH (kontra AC→D)
English: Uncommon side effects of Ontruzant (may affect up to 1 in 100 people):
Maltese: Effetti sekondarji mhux komuni ta' Ontruzant (jistgħu jaffettwaw sa persuna waħda minn kull 100):
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 b'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: Data from study JP16003, a single-arm study of trastuzumab (4 mg/kg loading dose as an intravenous infusion and 2 mg/kg infusion weekly) and docetaxel (60 mg/m2 intravenous infusion) in Japanese women with HER2-positive MBC, suggested that concomitant administration of trastuzumab had no effect on the single dose pharmacokinetics of docetaxel.
Maltese: 4 mg/kg bħala infużjoni ġol-vini u infużjoni ta' 2 mg/kg kull ġimgħa) u docetaxel (60 mg/m2 bħala infużjoni 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 il-farmakokinetika ta' doża waħda ta' docetaxel.
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 talglandoli limfatiċi, u mill-inqas 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'
English: How to store Ontruzant
Maltese: Kunjett ta' Ontruzant
English: By comparison of simulated serum trastuzumab concentrations after trastuzumab monotherapy (4 mg/kg loading/2 mg/kg q1w intravenous infusion) 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: trastuzumab (doża għolja tal-bidu ta' 4 mg/kg/2 mg/kg q1w bħala infużjoni ġol-vini) u konċentrazzjonijiet osservati fis-serum f'nisa Ġappuniżi b'MBC pożittiv għal HER2 (studju JP16003)
English: Disease-free survival No. patients with event p=0.0003
Maltese: Numru ta' pazjenti bl-avveniment p=0.0003
English: • You have metastatic gastric cancer with high levels of HER2, when it is in combination with the other cancer medicines capecitabine or 5-flououracil and cisplatin.
Maltese: • Għandek kanċer metastatiku tal-istonku b'livelli għoljin ta' HER2, meta jkun flimkien malmediċini l-oħra kontra l-kanċer capecitabine jew 5-flououracil u cisplatin.
English: Ontruzant 150 mg powder for concentrate for solution for infusion
Maltese: Ontruzant 150 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: Children and adolescents Ontruzant is not recommended for anyone under the age of 18 years.
Maltese: Tfal u adolexxenti Ontruzant mhux rakkomandat għall-persuni b'età inqas minn 18-il sena.
English: The pharmacokinetics of trastuzumab were evaluated in a population pharmacokinetic model analysis using pooled data from 1,582 subjects, including patients with HER2-positive MBC, EBC, AGC or other tumour types, and healthy volunteers, in 18 Phase I, II and III trials receiving trastuzumab via an intravenous infusion.
Maltese: Il-farmakokinetika ta' trastuzumab kienet evalwata f'analiżi ta' mudell tal-farmakokinetika tal popolazzjoni bl-użu ta' dejta miġbura minn 1,582 individwu, fosthom pazjenti b'MBC, EBC, AGC
English: Distant recurrence No. patients with event p=0.0008
Maltese: Metastasi Numru ta' pazjenti bl-avveniment p=0.0008
English: - Keep this leaflet.
Maltese: Proporzjon ta' periklu kontra
English: The efficacy results from the joint analysis of the NSABP B-31 and NCCTG 9831 trials at the time of the definitive analysis of DFS* are summarized in Table 7.
Maltese: Ir-riżultati tal-effikaċja mill-analiżi konġunta tal-provi NSABP B-31 u NCCTG 9831 fil-ħin tal analiżi definittiva ta' DFS* huma miġbura fil-qosor f'Tabella 7.
English: Subsequent Ontruzant 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 ilprogrammi ta' darba fil-ġimgħa jew ta' darba kull tliet ġimgħat, rispettivament.
English: Always keep this medicine in the closed original pack at a temperature of 2ºC - 8ºC in a refrigerator.
Maltese: Dejjem żomm din il-mediċina fil-pakkett oriġinali magħluq f'temperatura ta' 2ºC - 8 ºC fil-friġġ.
English: Infusion related reaction
Maltese: Reazzjonijiet relatata mal-infużjoni
English: HER2 testing is mandatory prior to initiation of therapy (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: Body weight (kg) x dose (4 mg/kg for loading or 2 mg/kg for maintenance) 21 (mg/mL, concentration of reconstituted solution)
Maltese: Piż tal-ġisem(kg) x doża (4 għad-doża ogħla tal-bidu jew 2 mg/kg għad-doża ta'
English: Excipients:
Maltese: Sími:
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: edima pulmonari, gallop S3, jew porzjon imbuttat 'il barra mill-ventriklu imnaqqsa, ikunu osservati f'pazjenti kkurati b'trastuzumab (ara sezzjoni 4.4).
English: NAME OF THE MEDICINAL PRODUCT Ontruzant 150 mg powder for concentrate for solution for infusion trastuzumab
Maltese: U KWANTITATTIVA Ontruzant 150 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: Common side effects of Ontruzant (may affect up to 1 in 10 people):
Maltese: Effetti sekondarji komuni ta' Ontruzant (jistgħu jaffettwaw sa persuna waħda minn kull 10):
English: DCarbH (vs. AC→D) (BCIRG 006)
Maltese: (BCIRG 006)
English: Store in a refrigerator (2°C - 8°C).
Maltese: Aħżen fi friġġ (2ºC - 8ºC).
English: Primary tumour type N
Maltese: • imnieħer inixxi
English: Body weight (kg) x dose (8 mg/kg for loading or 6 mg/kg for maintenance) 21 (mg/mL, concentration of reconstituted solution)
Maltese: Piż tal-ġisem(kg) x doża (8 għad-doża ogħla tal-bidu jew 6 mg/kg għad-doża ta'
English: STATEMENT OF ACTIVE SUBSTANCE(S) The vial contains 420 mg trastuzumab.
Maltese: Il-kunjett fih 420 mg trastuzumab.
English: In the neoadjuvant-adjuvant EBC study (BO22227), at a median follow-up exceeding 70 months, 10.1% (30/296) of patients treated with intravenous trastuzumab developed antibodies against trastuzumab.
Maltese: 1 % (30/296) tal-pazjenti kkurati b'trastuzumab fil-vini żviluppaw antikorpi kontra trastuzumab.
English: Brain oedema
Maltese: Ż-ŻGĦAR EWLENIN
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'
English: Effect of antineoplastic agents on trastuzumab pharmacokinetics
Maltese: paclitaxel fuq il-farmakokinetika ta' trastuzumab.
English: Ontruzant 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 several chromatography steps including specific viral inactivation and removal procedures.
Maltese: IgG1 umanizzat magħmul permezz ta' koltura ta' suspensjoni ta' ċelluli mammiferi (ovarju ta' ħamster Ċiniż) u ppurifikat permezz ta' diversi passi tal-kromatografija inkluż proċeduri speċifiċi ta' inattivazzjoni u tneħħija virali.
English: What Ontruzant looks like and contents of the pack
Maltese: Għoti flimkien ma' inibitur ta' aromatase
English: AC→D = doxorubicin plus cyclophosphamide, followed by docetaxel; AC→DH = doxorubicin plus cyclophosphamide, followed by docetaxel plus trastuzumab; CI = confidence interval Table 10 Overview of efficacy analyses BCIRG 006 AC→D versus DCarbH
Maltese: AC→D = doxorubicin flimkien ma' cyclophosphamide, segwit minn docetaxel; AC→DH = doxorubicinflimkien ma' cyclophosphamide, segwit minn docetaxel flimkien ma' trastuzumab; CI = intervall ta' kunfidenza
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ontruzant 150 mg powder for concentrate trastuzumab
Maltese: Kunjett wieħed fih 150 mg ta' trastuzumab, antikorp monoklonali
English: The loading dose should be administered as a 90-minute intravenous infusion.
Maltese: Id-doża ogħla tal-bidu ta' Ontruzant għandha tingħata bħala infużjoni fil-vini fuq medda ta' 90 minuta.
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 b'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 tar-riċetturi beta.
English: Although there are some limitations when using Cairo-Bishop criteria for diagnosis leading to underestimation of the number of cases, the update of the Product Information to include TLS with a frequency unknown is endorsed, because trastuzumab is a potent mediator of antibody-dependent cell-mediated cytotoxicity (ADCC).
Maltese: Barra minn hekk, trastuzumab huwa medjatur qawwi ta' ċitotossiċità medjata miċ-ċelluli dipendenti minn antikorpi (ADCC - antibody-dependent cell-mediated cytotoxicity).
English: 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 mal-infużjoni huma: tħossok imdardar (tqalligħ), rimettar, uġigħ, żieda fit-tensjoni tal-muskoli u tregħid, uġigħ ta' ras, sturdament, diffikultajiet respiratorji, tħarħir, pressjoni għolja jew baxxa,
English: Ontruzant is a powder for concentrate for solution for intravenous infusion, which is supplied in a glass vial with a rubber stopper containing either 150 mg or 420 mg of trastuzumab.
Maltese: Ontruzant huwa trab għal konċentrat għall-soluzzjoni għall-infużjoni fil-vini, li huwa disponibbli f'kunjett tal-ħġieġ b'tapp tal-lastku li fih 150 mg jew 420 mg ta' trastuzumab.
English: Such methods must clearly be precise and accurate enough to demonstrate overexpression of HER2 and must be able to distinguish between moderate (congruent with 2+) and strong (congruent with 3+) overexpression of HER2.
Maltese: HER2 moderata (konformi ma' 2+) u qawwija (konformi ma' 3+).
English: The primary endpoint was overall survival which was defined as the time from the date of randomization to the date of death from any cause.
Maltese: Il punt finali primarju kien is-sopravivenza globali li kienet definita bħala ż-żmien mid-data ta'
English: The majority of patients with cardiac symptoms and evidence of a clinical benefit of trastuzumab treatment continued on therapy without additional clinical cardiac events.
Maltese: Il-maġġoranza tal-pazjenti b'sintomi kardijaċi u b'evidenza ta' benefiċċju kliniku ta' kura b'trastuzumab komplew fuq it-terapija mingħajr aktar avvenimenti kardijaċi kliniċi.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for trastuzumab, the scientific conclusions of the CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal trastuzumab, il konklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: Median TTP (months) (95%CI) Median survival (months) (95%CI)
Maltese: Rata ta' Rispons (95%CI) Tul Medjan tarrispons (xhur)
English: Monitoring may help to identify patients who develop cardiac dysfunction.
Maltese: Il-monitoraġġ jista' jgħin biex jiġu identifikati pazjenti li jiżviluppaw disfunzjoni kardijaka.
English: HER2 overexpression assessment
Maltese: Valutazzjoni tal espressjoniżejda ta' HER2
English: Administration in combination with paclitaxel or docetaxel 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: Għoti flimkien ma' paclitaxel jew docetaxel Fil-provi pivitali (H0648g, M77001), paclitaxel jew docetaxel ingħata l-għada tal-ewwel doża ta'
English: If you receive Ontruzant with any other medicine to treat cancer, such as paclitaxel, docetaxel, an aromatase inhibitor, capecitabine, 5-fluorouracil, or cisplatin you should also read the patient information leaflets for these products.
Maltese: docetaxel, inibitur ta' aromatase, capecitabine, 5-fluorouracil, jew cisplatin, għandek taqra wkoll il fuljett ta' tagħrif għal dawn il-prodotti.
English: One 40 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film containing 420 mg of trastuzumab
Maltese: Kunjett ta' 40 mL magħmul minn ħġieġ ċar tip I b'tapp tal-gomma butyl laminat b'kisja ta' fluoro-resin li fih 420 mg ta' trastuzumab.
English: Strong complete, basolateral or lateral membranous reactivity in ≥10% of tumour cells
Maltese: kompluta,bażolaterali jew laterali fil-membrana f'≥10% taċ-ċelluli tat-tumur.
English: 1Muscle tightness
Maltese: Uġigħ fid-dahar
English: No reactivity or membranous reactivity in <10% of tumour cells
Maltese: L-ebda reattività jew reattivitàfil-membrana f'<10% taċ-ċelluli tat-tumur
English: Ontruzant 420 mg powder for concentrate for solution for infusion Appropriate aseptic technique should be used.
Maltese: Ontruzant 420 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Għandha tintuża teknika asettika adattata.
English: • jaundice (yellowish discoloration of the skin or eyes)
Maltese: • dispepsja (ħruq ta' stonku)
English: Study H0648g: IHC3+ patient subset
Maltese: 41-0.81) fil-grupp ta' IHC3+/FISH+.
English: Diarrhoea
Maltese: Disġewżja
English: Pain
Maltese: jew
English: N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands
Maltese: N.V. Organon Kloosterstraat 6 5349 AB
English: 59452 LYS-LEZ-LANNOY France
Maltese: 59452 LYS-LEZ-LANNOY Franza
English: • VTE may be fatal in 1-2 % of cases.
Maltese: • VTE jista' jkun fatali f'1-2 % tal-każijiet.
English: Day 18-24
Maltese: Jum 18-24
English: THERAMEX France SAS Tél: 0800 100 350
Maltese: France SAS Tél: 0800 100 350
English: Zoely contains 17β-estradiol.
Maltese: Zoely fih 17β-estradiol.
English: Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1
Maltese: Theramex Ireland Limited 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1
English: Oral contraception.
Maltese: Kontraċezzjoni orali.
English: The absolute bioavailability is about 1 %.
Maltese: Il-bijodisponibilità assoluta hi ta' madwar 1 %.
English: Date of first authorisation: 27 July 2011 Date of latest renewal: 21 April 2016
Maltese: Data tal-aħħar tiġdid: 21 ta' April 2016
English: Day 8-17
Maltese: Jum 8-17
English: Day 1-7
Maltese: Jum 1-7
English: Medical examination/consultation
Maltese: Eżami mediku/konsultazzjoni medika
English: About 5-7 out of 10,000 women
Maltese: Madwar 5-7 minn 10,000 mara
English: EU/1/11/690/001 28 film-coated tablets EU/1/11/690/002 84 film-coated tablets EU/1/11/690/003 168 film-coated tablets EU/1/11/690/004 364 film-coated tablets
Maltese: EU/1/11/690/001 28 pillola miksija b'rita EU/1/11/690/002 84 pillola miksija b'rita EU/1/11/690/003 168 pillola miksija b'rita EU/1/11/690/004
English: Other medical conditions associated with adverse vascular events
Maltese: Kondizzjonijiet mediċi oħra assoċjati ma' avvenimenti vaskulari avversi