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,ss imbassra talpopolazzjoni, jew eliminazzjoni kompluta ta' madwar 97%) wara 7 xhur.
English: Patients who receive anthracyclines after stopping Herceptin may possibly be at increased risk of cardiac dysfunction.
Maltese: Pazjenti li jirċievu anthracyclines wara l-waqfien ta' Herceptin jistgħu jkunu f'riskju akbar ta' disfunzjoni kardijaka.
English: 1 Year N = 1693
Maltese: Sena Waħda N = 1693
English: Paediatric population There is no relevant use of Herceptin in the paediatric population.
Maltese: M'hemmx użu rilevanti ta' Herceptin fil-popolazzjoni pedjatrika.
English: Median duration of follow up was 1.8 years in the AC→P arm and 2.0 years in the AC→PH arm 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
Maltese: It-tul ta' żmien medjan ta' segwitu kien ta' 1.8 snin fil-grupp ta' AC→P u sentejn fil-grupp ta' AC→PH ** It-tul medjan ta' segwitu fit-tul għall-istudji kliniċi tal-Analiżi konġunta kien ta' 8.3 snin (firxa: 0.1 sa 12.1) għall-grupp ta' AC→PH u 7.9 snin (firxa: 0.0 sa 12.2) għall-grupp ta' AC→P;
English: One vial of 5 mL contains 600 mg of trastuzumab.
Maltese: Kunjett wieħed ta' 5 mL fih 600 mg ta' trastuzumab.
English: These tissues were fixed in formalin or Bouin's fixative.
Maltese: Dawn it-tessuti kienu fissi fil-formalina jew fis-sustanza fissattiva ta' Bouin.
English: Each vial contains 150 mg trastuzumab that has to be dissolved in 7.2 mL of water for injection.
Maltese: Kull kunjett fih 150 mg trastuzumab li għandu jiġi mdewweb f'7.2 mL ta' ilma għall-injezzjoni.
English: The test method for HER2 overexpression used to determine eligibility of patients in the pivotal Herceptin monotherapy and Herceptin plus paclitaxel clinical trials employed immunohistochemical staining for HER2 of fixed material from breast tumours using the murine monoclonal antibodies
Maltese: It-test użat biex titkejjel l-espressjoni żejda ta' HER2 sabiex jiġu determinati l-pazjenti eliġibbli għallprovi kliniċi pivitali ta' Herceptin bħala monoterapija u ta' Herceptin flimkien ma' paclitaxel għamel użu minn metodu immunoistokimiku ta' tbajja għal HER2 ta' materjal fiss minn tumuri tas-sider blużu tal-antikorpi monoklonali tal-ġurdien CB11 u 4D5.
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 Herceptin and paclitaxel and two Phase II studies in which Herceptin 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 Herceptin 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: 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 Herceptin 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 Herceptin).
Maltese: F'wieħed mit3 studji pivitali mwettqa fejn kien disponibbli segwitu medjan ta' 5.5 snin (BCIRG006) kienet osservata żieda kontinwa fir-rata kumulattiva ta' avvenimenti kardijaċi sintomatiċi jew avvenimenti ta' LVEF sa 2.37% f'pazjenti li ngħataw Herceptin flimkien ma' taxane wara terapija b'anthracycline meta mqabbel ma madwar 1% fiż-żewġ gruppi ta' paragun (anthracycline flimkien ma' cyclophosphamide segwit minn taxane u taxane, carboplatin u Herceptin).
English: • increased muscle tone or tension (hypertonia)
Maltese: • żjieda fit-ton jew tensjoni tal-muskoli (ipertonija)
English: No. patients with event p=0.0182
Maltese: Mewt (avveniment OS): Numru ta' pazjenti blavveniment p=0.0182
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: Administration in combination with paclitaxel or docetaxel
Maltese: Għoti flimkien ma' paclitaxel jew docetaxel
English: 1) Using a sterile syringe, slowly inject 7.2 mL of sterile water for injection in the vial containing the lyophilised Herceptin, directing the stream into the lyophilised cake.
Maltese: 1) Permezz ta' siringa sterili, injetta bil-mod 7.2 mL ta' ilma għall-injezzjoni sterili fil-kunjett li fih ittrab lajofilizzat ta' Herceptin, billi timmira l-fluss ġot-trab lajofilizzat.
English: The population predicted PK exposure parameter values (median with 5th - 95th Percentiles) for Herceptin SC dosing regimens in EBC patients are shown in Table 13 below.
Maltese: Valuri mbassra tal-parametru ta' esponiment PK tal-Popolazzjoni (medjan b'5 - 95 Percentiles) għal korsijiet ta' dożaġġ ta' Herceptin SC f'pazjenti b'EBC huma murija fit-Tabella 13 hawn taħt.
English: Based on the observed data in study BO22227, steady state with the intravenous formulation was reached at cycle 8.
Maltese: Ibbażat fuq id-dejta osservata fi studju BO22227, stat fiss bil-formulazzjoni għall-għoti fil-vini intlaħaq f'ċiklu 8.
English: Study BO22227 was designed to demonstrate non-inferiority of treatment with Herceptin subcutaneous formulation versus Herceptin intravenous formulation based on co-primary PK and efficacy endpoints (trastuzumab Ctrough at pre-dose Cycle 8, and pCR rate at definitive surgery, respectively).
Maltese: Studju BO22227 kien maħsub biex juri in-nuqqas ta' inferjorità ta' trattament bil-formulazzjoni għallgħoti taħt il-ġilda ta' Herceptin kontra l-formulazzjoni għall-għoti fil-vini ta' Herceptin ibbażat fuq punti finali ko-primarji tal-PK u l-effikaċja (Ctrough ta' trastuzumab qabel id-doża ta' Ċiklu 8, u r-rata ta' pCR waqt kirurġija definittiva, rispettivament).
English: In 3 pivotal EBC clinical trials of adjuvant intravenous Herceptin given in combination with chemotherapy, the incidence of grade 3/4 cardiac dysfunction (specifically symptomatic congestive heart failure) was similar in patients who were administered chemotherapy alone (ie did not receive Herceptin) and in patients who were administered Herceptin sequentially after a taxane (0.3-0.4 %).
Maltese: Fi 3 provi kliniċi pivitali dwar EBC b'Herceptin awżiljarju fil-vini mogħti flimkien ma' kimoterapija, l-inċidenza ta' disfunzjoni kardijaka ta' grad 3/4 (b'mod speċifiku insuffiċjenza konġestiva tal-qalb sintomatika) kienet simili f'pazjenti li ngħataw kimoterapija waħedha (jiġifieri ma rċevewx Herceptin) u f'pazjenti li ngħataw Herceptin b'mod sekwenzjali wara taxane (0.3-0.4 %).
English: Herceptin is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC).
Maltese: Herceptin huwa indikat għall-kura ta' pazjenti adulti b'kanċer bikri tas-sider (EBC - early breast cancer) pożittiv għal HER2.
English: The rate of severe infections (NCI CTCAE grade ≥3) was 5.0 % versus 7.1 %, in the Herceptin intravenous formulation arm and the Herceptin subcutaneous formulation arm respectively.
Maltese: Ir-rata ta' infezzjonijiet severi (NCI CTCAE grad ≥3) kienet ta' 5.0 % kontra 7.1 %, fil-grupp talformulazzjoni għall-għoti fil-vini ta' Herceptin u fil-grupp tal-formulazzjoni għall-għoti taħt il-ġilda ta' Herceptin rispettivament.
English: Switching treatment between Herceptin intravenous and Herceptin subcutaneous formulations and vice versa, using the three-weekly (q3w) dosing regimen, was investigated in study MO22982 (see section 4.8).
Maltese: Bidla minn kura għall-oħra bejn il-formulazzjonijiet ta' Herceptin għall-għoti fil-vini u Herceptin għall-għoti taħt il-ġilda u viċe versa, bl-użu ta' kors ta' dożaġġ ta' kull tliet ġimgħat (q3w), kienet investigata fl-istudju MO22982 (ara sezzjoni 4.8).
English: In this trial, 2 cohorts (one using subcutaneous formulation in vial and one using subcutaneous formulation in administration system) were investigated using a 2-arm, cross-over design with 488 patients being randomized to one of two different three-weekly Herceptin treatment sequences (IV [Cycles 1-4]→ SC [Cycles 5-8], or SC [Cycles 1-4]→ IV [Cycles 5-8]).
Maltese: F'din il-prova, 2 koorti (wieħed fejn intużat il-formulazzjoni għall-għoti taħt il-ġilda f'kunjett u ieħor fejn intużat il-formulazzjoni għall-għoti taħt il-ġilda f'sistema ta' għoti) kienu investigati permezz ta' mudell cross-over b'żewġ gruppi fejn 488 pazjent kienu randomised għal waħda minn żewġ sekwenzi differenti ta' kura b'Herceptin kull tliet ġimgħat (IV [Ċikli 1-4] → [SC Ċikli 5-8], jew [SC Ċikli 1-4] → IV [Ċikli 5-8]).
English: Table 7: Final Overall Survival Analysis from the joint analysis of trials NSABP B-31 and NCCTG N9831
Maltese: Tabella 7 Analiżi Finali tas-Sopravivenza Globali mill-analiżi konġunta tal-provi NSABP B-31 u NCCTG N9831
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 lbidla (Ċikli 5-8).
English: The non-linear elimination parameter values were 8.81 mg/day for the maximum elimination rate (Vmax) and 8.92
Maltese: Il-valuri tal-parametru ta' eliminazzjoni mhux lineari kienu ta' 8.81 mg/jum għar-rata massima ta' eliminazzjoni (Vmax - maximum elimination rate) u ta' 8.92 µg/mL għall-kostanti ta' Michaelis-Menten (Km - Michaelis-Menten constant) għall-pazjenti b'MBC, EBC, u AGC.
English: +Bronchospasm
Maltese: Bronkospażmu
English: Tabulated list of adverse reactions with the intravenous formulation
Maltese: Lista ta' reazzjonijiet avversi f'tabella
English: AC→D
Maltese: Qtugħ ta' nifs
English: In the neoadjuvant setting, the experience of concurrent administration of Herceptin and low dose anthracycline regimen is limited (see section 4.4).
Maltese: Fl-ambjent neoawżiljarju, l-esperjenza tal-għoti ta' Herceptin flimkien ma' kors ta' doża baxxa ta' anthracycline hija limitata (ara sezzjoni 4.4).
English: • The other ingredient(s) are L-histidine hydrochloride monohydrate, L-histidine, α,α-trehalose dihydrate, polysorbate 20.
Maltese: Is-sustanza(i) l-oħra huma L-histidine hydrochloride monohydrate, L-histidine, α,α-trehalose dihydrate, polysorbate 20.
English: Analyses with longer term follow-up of a median duration exceeding 40 months supported the noninferior efficacy of Herceptin subcutaneous compared to Herceptin intravenous with comparable results of both EFS and OS (3-year EFS rates of 73% in the Herceptin intravenous arm and 76% in the Herceptin subcutaneous arm, and 3-year OS rates of 90% in the Herceptin intravenous arm and 92% in the Herceptin subcutaneous arm).
Maltese: Analiżi bi żmien ta' segwitu itwal ta' tul medjan ta' aktar minn 40 xahar sostna n-nuqqas ta' inferjorità tal-effikaċja ta' Herceptin taħt il-ġilda meta mqabbla ma' Herceptin fil-vini b'riżultati komparabbli kemm ta' EFS kif ukoll ta' OS (rati ta' EFS ta' 3 snin ta' 73% fil-grupp ta' Herceptin fil-vini u ta' 76% fil-grupp ta' Herceptin taħt il-ġilda, u rati ta' OS ta' 3 snin ta' 90% fil-grupp ta' Herceptin fil-vini u ta' 92% fil-grupp ta' Herceptin taħt il-ġilda).
English: The final results of study BO22227 at a median follow-up exceeding 70 months were also consistent with the known safety profile for Herceptin IV and Herceptin SC, and no new safety signals were observed.
Maltese: Ir-riżultati finali tal-istudju BO22227 waqt segwitu medjan li jaqbeż 70 xahar kienu konsistenti wkoll mal-profil ta' sigurtà magħruf għal Herceptin IV u Herceptin SC, u ma ġewx osservati sinjali ta' sigurtà ġodda.
English: 1 Heart beat irregular
Maltese: 1 Taħbit tal-qalb irregolari
English: Uncommon side effects of Herceptin: may affect up to 1 in 100 people:
Maltese: Effetti sekondarji mhux komuni ta' Herceptin: jistgħu jaffettwaw sa persuna waħda minn kull 100:
English: The hazard ratio translates into an absolute benefit, in terms of 3-year disease-free survival rate estimates of 11.8 percentage points (87.2 % versus 75.4 %)
Maltese: Il-proporzjon ta' periklu jittraduċi f'benefiċċju assolut, f'termini ta' stimi ta' rata ta' sopravivenza mingħajr il-marda ta' 3 snin ta' 11.8 punti perċentwali (87.2 % kontra 75.4 %) favur il-grupp ta' AC→PH (Herceptin).
English: Table 3: Efficacy results from the monotherapy and combination therapy studies Parameter
Maltese: Tabella 3: Riżultati tal-effikaċja minn studji ta' monoterapija u ta' terapija kombinata
English: In the pivotal trial BO22227, Herceptin 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 Herceptin intravenous arm and 0.7% in the Herceptin subcutaneous arm.
Maltese: BO22227, Herceptin ingħata flimkien ma' kimoterapija neoawżiljarja li kien fiha erba' ċikli ta' epirubicin (doża kumulattiva ta' 300 mg/m2); waqt segwitu medjan li jaqbeż 70 xahar, linċidenza ta' insuffiċjenza tal-qalb/insuffiċjenza konġestiva tal-qalb kienet ta' 0.3% fil-grupp ta' Herceptin fil-vini u ta' 0.7% fil-grupp ta' Herceptin taħt il-ġilda.
English: Renal and urinary disorders Renal disorder
Maltese: Disturbi fil-kliewi u fissistema urinarja
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: No. patients with event p=0.0024
Maltese: Mewt (avveniment OS): Numru ta' pazjenti blavveniment p=0.0024
English: • asthma • infection of lungs
Maltese: • ażżma • infezzjoni fil-pulmun
English: In 3 pivotal clinical trials of adjuvant Herceptin given in combination with chemotherapy, the incidence of grade 3/4 cardiac dysfunction (specifically symptomatic Congestive Heart Failure) was similar in patients who were administered chemotherapy alone (ie did not receive Herceptin) and in patients who were administered Herceptin sequentially after a taxane (0.3-0.4 %).
Maltese: Fi 3 provi kliniċi pivitali b'Herceptin mogħti b'mod awżiljarju flimkien ma' kimoterapija, l-inċidenza ta' disfunzjoni kardijaka ta' grad 3/4 (b'mod speċifiku Insuffiċjenza Konġestiva tal-Qalb sintomatika) kienet simili f'pazjenti li ngħataw kimoterapija waħedha (jiġifieri ma rċevewx Herceptin) u f'pazjenti li ngħataw Herceptin b'mod sekwenzjali wara taxane (0.3-0.4 %).
English: Table 1 Undesirable Effects Reported with Intravenous Herceptin Monotherapy or in Combination with Chemotherapy in Pivotal Clinical Trials (N = 8386) and in Post-Marketing
Maltese: Tabella 1 Effetti Mhux Mixtieqa Rrappurtati b'Herceptin fil-Vini bħala Monoterapija jew Flimkien ma' Kimoterapija fi Provi Kliniċi Pivitali (N = 8386) u Wara t-Tqegħid fis-Suq
English: Median TTP (months) (95 %CI)
Maltese: ta' 95 %) TTP Medjan (xhur) (CI ta'
English: Herceptin SC 600 mg Q3W Dosing Regimen in EBC patients
Maltese: Percentiles) għal Kors ta' Dożaġg ta' Herceptin SC 600 mg Q3W f'Pazjenti b'EBC
English: All candidates for treatment with Herceptin, 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'Herceptin, 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: White to pale yellow lyophilised powder.
Maltese: Mhux meħtieġa doża għolja tal-bidu.
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 10: Table 10: Post-hoc exploratory analysis results from the joint analysis NSABP B-31/NCCTG N9831*
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: Tabella 11 Riżultati tal-Analiżi Esploratorja Post-Hoc mill-Analiżi Konġunta tal-Istudji Kliniċi NSABP B-31/NCCTG N9831* u BCIRG006 li Jikkombinaw Avvenimenti ta' DFS u Avvenimenti
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) 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: In study BO16348, after a median follow-up of 8 years the incidence of severe CHF (NYHA Class III & IV) in the Herceptin 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'Herceptin 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: Each vial of Herceptin is reconstituted with 7.2 mL of water for injections (not supplied).
Maltese: Kull kunjett ta' Herceptin huwa rikostitwit b'7.2 mL ta' ilma għall-injezzjonijiet (mhux fornut).
English: Early breast cancer - (neoadjuvant-adjuvant setting)
Maltese: Kanċer bikri tas-sider - (ambjent neoawżiljarju-awżiljarju)
English: Herceptin and anthracyclines should not be given concurrently in combination in the MBC setting.
Maltese: Herceptin 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 Herceptin 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' Herceptin fil-vini.
English: In the pivotal trial of docetaxel (100 mg/m2 infused over 1 hour) with or without Herceptin, 60 % of the patients had received prior anthracycline-based adjuvant chemotherapy.
Maltese: Fil-prova pivitali ta' docetaxel (100 mg/m mogħti bħala infużjoni fuq medda ta' siegħa) bi jew mingħajr Herceptin, 60% tal-pazjenti kienu rċevew kimoterapija awżiljarja bbażata fuq anthracycline minn qabel.
English: The 600 mg dose should be administered as a subcutaneous injection only over 2-5 minutes every three weeks.
Maltese: Id-doża ta' 600 mg għandha tingħata biss bħala injezzjoni taħt il-ġilda fuq 2-5 minuti kull tliet ġimgħat.
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: (N=2032)
Maltese: AC→P (N=2032)
English: The final analysis at a median follow-up exceeding 70 months showed similar EFS and OS between patients who received Herceptin IV and those who received Herceptin SC.
Maltese: L-analiżi finali waqt segwitu medjan li jaqbeż 70 xahar uriet EFS u OS simili bejn pazjenti li rċevew Herceptin IV u dawk li rċevew Herceptin SC.
English: It is not known whether Herceptin can affect reproductive capacity.
Maltese: Mhux magħruf jekk Herceptin jistax jeffettwa l-kapaċità riproduttiva.
English: +Respiratory failure
Maltese: Insuffiċjenza respiratorja
English: The median duration of follow-up in the Herceptin arm was 3.8 years.
Maltese: It-tul medjan ta' segwitu fil-grupp ta' Herceptin kien ta' 3.8 snin.
English: In the pivotal trial BO22227, Herceptin 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 Herceptin intravenous arm.
Maltese: BO22227, Herceptin ingħata flimkien ma' kimoterapija neoawżiljarja li kien fiha erba' ċikli ta' epirubicin (doża kumulattiva ta' 300 mg/m2); waqt segwitu medjan li jaqbeż 70 xahar, l-inċidenza ta' insuffiċjenza talqalb/insuffiċjenza konġestiva tal-qalb kienet ta' 0.3% fil-grupp ta' Herceptin fil-vini.
English: (N=2031)
Maltese: AC→PH (N=2031)
English: which was followed by • Paclitaxel 175 mg/m2 administered 3-weekly for 4 cycles,
Maltese: li kienu segwiti minn - Paclitaxel 175 mg/m mogħti darba kull 3 ġimgħat għal 4 ċikli,
English: • nausea.
Maltese: FISH pożittiv.
English: All candidates for treatment with Herceptin, but especially those with prior anthracycline and cyclophosphamide exposure, should undergo baseline cardiac assessment including history and physical examination and electrocardiogram (ECG), echocardiogram, and/or multigated acquisition (MUGA) scan or magnetic resonance imaging.
Maltese: Kull min jista' jingħata kura b'Herceptin, iżda b'mod speċjali dawk esposti minn qabel għal anthracycline u cyclophosphamide, għandu jkollhom stima kardijaka bħala linja bażi inkluż passat mediku u eżami fiżiku u elettrokardjogramm (ECG - electrocardiogram), ekokardjogramm, u/jew skan multigated acquisition (MUGA) jew magnetic resonance imaging.
English: Lonza Portsmouth
Maltese: Ġilda xotta