FrancophonIA/ELRC3.0 huggingface dataset:
English: Number (%) of patients with event HR [95% CI] p-value (Log-Rank test, unstratified) 3 year event-free rate
Maltese: Numru (%) ta' pazjenti b'avveniment HR [CI ta' 95%] valur p (test Log-Rank, mhux stratifikat) rata ta' 3 snin mingħajr avveniment
English: LVEF 45% to < 50% and decrease is < 10% points from baseline*
Maltese: LVEF 45% sa < 50% u t-tnaqqis huwa ta' < 10 punti % mil-linja bażi*
English: · The other ingredients are succinic acid, sodium hydroxide (see section 2 under ‘Important information about some of the ingredients of Kadcyla'), sucrose, and polysorbate 20.
Maltese: ● Is-sustanzi l-oħra huma succinic acid, sodium hydroxide (ara sezzjoni 2 taħt ‘Tagħrif importanti dwar xi wħud mill-ingredjenti ta' Kadcyla'), sucrose, u polysorbate 20.
English: 10.8 months and not reached, respectively, compared with 5.7 months and 27.9 months, respectively, for the lapatinib plus capecitabine group.
Maltese: 8 xhur u ma ntlaħqitx, rispettivament, meta mqabbla ma' 5.7 xhur u 27.9 xhur, rispettivament, għall-grupp ta' lapatinib flimkien ma' capecitabine.
English: A treatment benefit was seen in the subgroup of patients who had relapsed within 6 months of completing adjuvant treatment and had not received any prior systemic anti-cancer therapy in the metastatic setting (n=118); hazard ratios for PFS and OS were 0.51 (95% CI: 0.30, 0.85) and 0.61 (95% CI: 0.32, 1.16), respectively.
Maltese: Benefiċċju tat-trattament kien osservat fis-sottogrupp ta' pazjenti li rkadew fi żmien 6 xhur wara li spiċċaw trattament awżijlarju u li ma rċevew l-ebda terapija sistemika minn qabel kontra l-kanċer f'ambjent metastatiku (n=118); il-proporzjonijiet ta' periklu għal PFS u OS kienu ta' 0.51 (CI ta' 95%: 0.30, 0.85) u 0.61 (CI ta' 95%: 0.32, 1.16), rispettivament.
English: · the most common serious ADRs (> 0.5% of patients) were haemorrhage, pyrexia, thrombocytopenia, dyspnoea, abdominal pain, musculoskeletal pain, and vomiting.
Maltese: ● l-ADRs serji l-aktar komuni (> 0.5% tal-pazjenti) kienu emorraġija, deni, tromboċitopenija, qtugħ ta' nifs, uġigħ addominali, uġigħ muskoluskeletriku, u rimettar.
English: Only patients with Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 were eligible.
Maltese: Pazjenti bi Stat ta' Ħila (PS - Performance Status) tal-Grupp tal-Onkoloġija tal-Kooperattiva tal-Lvant (ECOG - Eastern Cooperative Oncology Group) ta' 0 jew 1 biss kienu eliġibbli.
English: The reconstituted Kadcyla solution should be diluted in polyvinyl chloride (PVC) or latex-free PVC-free polyolefin infusion bags.
Maltese: Is-soluzzjoni rikostitwita ta' Kadcyla għandha tiġi dilwita f'boroż tal-infużjoni ta' polyvinyl chloride (PVC) jew polyolefin ħieles minn latex u PVC.
English: What Kadcyla contains · The active substance is trastuzumab emtansine.
Maltese: ● Is-sustanza attiva hi trastuzumab emtansine.
English: Table 6 Summary of efficacy from study BO27938 (KATHERINE) Trastuzumab N = 743
Maltese: Tabella 6 Sommarju tal-effikaċja mill-istudju BO27938 (KATHERINE)
English: Animal studies of maytansine, a closely related chemical entity of the same maytansinoid class as DM1, suggest that DM1, the microtubule inhibiting cytotoxic component of trastuzumab emtansine, is expected to be teratogenic and potentially embryotoxic (see section 5.3).
Maltese: Studji fuq l-annimali dwar maytansine, entità kimika relatata mill-qrib tal-istess klassi maytansinoid bħal DM1, jissuġġerixxu li DM1, il-komponent ċitotossiku li jinibixxi l-mikrotubuli ta' trastuzumab emtansine, huwa mistenni li jkun teratoġeniku u potenzjalment embrijotossiku (ara sezzjoni 5.3).
English: LVEF 40% to ≤ 45% and decrease is < 10% points from baseline
Maltese: LVEF 40% sa ≤ 45% u ttnaqqis huwa ta' < 10 punti % mil-linja bażi
English: In the KATHERINE (BO27938) study, 3.7% (15/401) of patients tested positive for anti-trastuzumab emtansine antibodies, of which 5 were also positive for neutralizing antibodies.
Maltese: Fl-istudju KATHERINE (BO27938), 3.7% (15/401) tal-pazjenti kellhom test pożittiv għall-antikorpi kontra trastuzumab emtansine, li 5 minnhom kienu pożittivi wkoll għal antikorpi newtralizzanti.
English: Chemical and physical in-use stability of the reconstituted solution has been demonstrated for up to 24 hours at 2°C to 8°C.
Maltese: Stabbilità kimika u fiżika waqt l-użu tas-soluzzjoni rikostitwita ġiet murija għal 24 siegħa f'temperatura ta' 2°C sa 8°C.
English: Important information about some of the ingredients of Kadcyla This medicine contains less than 1 mmol sodium (23 mg) per dose.
Maltese: Din il-mediċina fiha anqas minn 1 mmol ta' sodium (23 mg) f'kull doża.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/885/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/885/001
English: Trastuzumab emtansine is an antibody-drug conjugate that contains trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture, covalently linked to DM1, a microtubule inhibitor, via the stable thioether linker MCC (4-[N-maleimidomethyl] cyclohexane-1-carboxylate).
Maltese: IgG1 umanizzat magħmul permezz ta' koltura ta' suspensjoni ta' ċelluli mammiferi (ovarju ta' ħamster Ċiniż), imwaħħal b'mod kovalenti ma' DM1, inibitur tal-mikrotubuli, permezz talmolekula stabbli li teħel ma' thioether, MCC (4-[N-maleimidomethyl] cyclohexane-1-carboxylate).
English: Left ventricular dysfunction occurred in 3.0% of patients with EBC, with Grade 3 or 4 in 0.5% of patients.
Maltese: Disfunzjoni tal-ventrikolu tax-xellug seħħet fi 3.0% tal-pazjenti b'EBC, bi Grad 3 jew 4 f'0.5% talpazjenti.
English: · Kadcyla 160mg: using a sterile syringe, slowly inject 8 mL of sterile water for injection into the
Maltese: ● Kadcyla 160mg: bl-użu ta' siringa sterili, injetta bil-mod 8 mL ta' ilma għall-injezzjoni sterili fil-kunjett ta' 160 mg trastuzumab emtansine.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/885/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/885/002
English: The median duration of response by IRC was not reached (95% CI, 4.6 months to not estimable).
Maltese: It-tul medjan tar-rispons skont IRC ma ntlaħaqx (CI ta' 95%, 4.6 xhur sa ma jistax jiġi stmat).
English: No dose adjustment is required in patients aged ≥ 65 years.
Maltese: Mhux meħtieġ aġġustament fid-doża f'pazjenti b'età ta' ≥ 65 sena.
English: BO27938 (KATHERINE) was a randomized, multicenter, open-label trial of 1486 patients with HER2-positive, early breast cancer with residual invasive tumor (patients who had not achieved pathological complete response (pCR)) in the breast and/or axillary lymph nodes following completion of preoperative systemic therapy that included chemotherapy and HER2-targeted therapy.
Maltese: BO27938 (KATHERINE) kienet prova randomised, b'aktar minn ċentru wieħed u open-label ta' 1,486 pazjent b'kanċer bikri tas-sider pożittiv għal HER2 b'tumur invażiv residwu (pazjenti li ma kinux kisbu rispons sħiħ patoloġiku (pCR - pathological complete response) fis-sider u/jew filglandoli limfatiċi tal-abt wara tlestija ta' terapija sistemika ta' qabel il-kirurġija li kienet tinkludi kimoterapija u terapija mmirata lejn HER2.
English: Dizziness, Dysgeusia, Memory impairment
Maltese: Sturdament, Disġewżja, Indeboliment filmemorja
English: Thrombocytopenia was reported in 28.5% of patients in EBC clinical studies with trastuzumab emtansine and was the most common reported adverse reaction for all grades and grades ≥ 3, as well as the most common adverse reaction leading to treatment discontinuation (4.2%), dose interruptions, and dose reductions.
Maltese: Tromboċitopenija kienet irrappurtata fi 28.5% tal-pazjenti fl-istudji kliniċi dwar EBC bi trastuzumab emtansine u kienet l-aktar reazzjoni avversa komuni rrappurtata għall-gradi kollha u l-gradi ta' ≥ 3, kif ukoll l-aktar reazzjoni avversa komuni li wasslet għal waqfien tat-trattament (4.2%), interruzzjonijiet tad-doża, u tnaqqis fid-doża.
English: Kadcyla is not recommended for anyone under the age of 18 years.
Maltese: Kadcyla mhux rakkomandat għal persuni b'età inqas minn 18-il sena.
English: Hypersensitivity was reported in 2.6% of patients in MBC clinical studies with trastuzumab emtansine, with one Grade 3 and one Grade 4 events reported.
Maltese: Sensittività eċċessiva kienet irrappurtata fi 2.6% tal-pazjenti fl-istudji kliniċi dwar MBC b'trastuzumab emtansine, b'rapport ta' avveniment wieħed ta' Grad 3 u wieħed ta' Grad 4.
English: Table 5 Laboratory abnormalities observed in patients treated with trastuzumab emtansine in study BO27938/KATHERINE
Maltese: Anormalitajiet tal-laboratorju osservati f'pazjenti ttrattati bi trastuzumab emtansine fl-istudju BO27938/KATHERINE
English: In nonclinical studies, trastuzumab emtansine catabolites including DM1, Lys-MCC-DM1, and MCC-DM1 are mainly excreted in the bile with minimal elimination in urine.
Maltese: Fi studji mhux kliniċi, kataboliti ta' trastuzumab emtansine inkluż DM1, Lys-MCC-DM1, u MCC-DM1fil-biċċa l-kbira kienu eliminati fil-bili b'eliminazzjoni minima fl-awrina.
English: Hepatotoxicity, predominantly in the form of asymptomatic increases in the concentrations of serum transaminases (Grade 1-4 transaminitis), has been observed during treatment with trastuzumab emtansine in clinical studies (see section 4.8).
Maltese: Tossiċità tal-fwied, l-aktar fil-forma ta' żidiet mingħajr sintomi fil-konċentrazzjonijiet ta' transaminases fis-serum (transaminite ta' Grad 1-4), kienet osservata waqt trattament bi trastuzumab emtansine fi studji kliniċi (ara sezzjoni 4.8).
English: MBC patients with Grade ³ 3 and EBC patients with Grade ³ 2 peripheral neuropathy at baseline were excluded from clinical studies.
Maltese: Pazjenti b'MBC b'newropatija periferali ta' Grad ≥ 3 u pazjenti b'EBC b'newropatija periferali ta' Grad ≥ 2 fil-linja bażi kienu esklużi minn studji kliniċi.
English: If the LVEF has not recovered to within 10% points from baseline, discontinue trastuzumab emtansine.
Maltese: Jekk l-LVEF ma jkunx irkupra sa 10 punti % mil-linja bażi, waqqaf trastuzumab emtansine.
English: Principal toxicities included liver (liver enzyme elevations) at ³ 20 mg/kg and ³ 10 mg/kg, bone marrow (reduced platelet and white blood cell count)/hematologic at ³ 20 mg/kg and ³ 10 mg/kg, and lymphoid organs at ³ 20 mg/kg and ³ 3 mg/kg, in rat and monkey, respectively.
Maltese: It-tossiċitajiet prinċipali kienu jinkludu l-fwied (żieda fl-enzimi tal-fwied) b'≥ 20 mg/kg u ≥ 10 mg/kg, il-mudullun (plejtlits u għadd ta' ċelluli bojod imnaqqsa)/ematoloġiċi b'≥ 20 mg/kg u ≥ 10 mg/kg, u l-organi limfojdi b'≥ 20 mg/kg u ≥ 3 mg/kg, fil-firien u fix-xadini, rispettivament.
English: Particulates may be observed on storage if diluted in 0.9% sodium chloride (see section 6.6).
Maltese: Jekk dilwita f'0.9% sodium chloride jista' jiġi osservat frak żgħir waqt il-ħażna (ara sezzjoni 6.6).
English: Determine the volume of the reconstituted solution required based on a dose of 3.6 mg trastuzumab emtansine/kg body weight:
Maltese: Iddetermina l-volum tas-soluzzjoni rikostitwita meħtieġ ibbażat fuq doża ta' 3.6 mg trastuzumab emtansine/kg ta' piż tal-ġisem:
English: - Plasma concentrations of DM1 and DM1-containing catabolites (Lys-MCC-DM1 and MCC-DM1) were low and comparable between patients with and without hepatic impairment.
Maltese: - Il-konċentrazzjonijiet fil-plażma ta' DM1 u ta' kataboliti li fihom DM1 (Lys-MCC-DM1 u MCCDM1) kienu baxxi u komparabbli bejn pazjenti b'indeboliment epatiku u dawk mingħajru.
English: LVEF 40% to ≤ 45% and decrease is ≥ 10%
Maltese: LVEF 40% sa ≤ 45% u ttnaqqis huwa ta' ≥ 10 punti % mil-linja bażi
English: If diluted aseptically, it may be stored for up to 24 hours at 2°C to 8°C.
Maltese: Jekk dilwit b'mod asettiku, jista' jinħażen sa 24 siegħa f'temperatura ta' 2°C sa 8°C.
English: Thrombocytopenia or decreased platelet counts were reported in 24.9% of patients in MBC clinical studies with trastuzumab emtansine and was the most common adverse reaction leading to treatment discontinuation (2.6%).
Maltese: Tromboċitopenija jew tnaqqis fl-għadd ta' plejtlits kienu rrappurtati f'24.9% tal-pazjenti fl-istudji kliniċi dwar MBC bi trastuzumab emtansine u kienet l-aktar reazzjoni avversa komuni li wasslet għal waqfien tat-trattament (2.6%).
English: In the subgroup of patients with non-measurable disease (n=205), based on IRC assessments, the hazard ratios for PFS and OS were 0.91 (95% CI: 0.59, 1.42) and 0.96 (95% CI: 0.54, 1.68),
Maltese: Fis-sottogrupp ta' pazjenti b'marda li ma tistax titkejjel (n=205), ibbażat fuq valutazzjonijiet minn IRC, il-proporzjonijiet ta' periklu għal PFS u għal OS kienu ta' 0.91 (CI ta' 95%: 0.59, 1.42) u 0.96 (CI ta' 95%: 0.54, 1.68), rispettivament.
English: The median PFS was 9.2 months in the trastuzumab plus docetaxel arm and 14.2 months in the trastuzumab emtansine arm (hazard ratio, 0.59; p = 0.035), with a median follow-up of approximately 14 months in both arms.
Maltese: Il-PFS medjana kienet ta' 9.2 xhur fil-grupp ta' trastuzumab flimkien ma' docetaxel u 14.2 xhur fil-grupp ta' trastuzumab emtansine (proporzjon ta' periklu, 0.59; p = 0.035), b'segwitu medjan ta' madwar 14-il xahar fiż-żewġ gruppi.
English: All patients were previously treated with HER2-directed therapies (trastuzumab and lapatinib), and chemotherapy (anthracycline, taxane, and capecitabine) in the neoadjuvant, adjuvant, locally advanced, or metastatic setting.
Maltese: Il-pazjenti kollha kienu ttrattati minn qabel b'terapiji mmirati lejn HER2 (trastuzumab u lapatinib), u kimoterapija (anthracycline, taxane, u capecitabine) f'ambjent neoawżiljarju, awżiljarju, avanzat lokalment, jew metastatiku.
English: Kadcyla is for intravenous use.
Maltese: Kadcyla (trastuzumab emtansine)
English: A Phase III, randomised, multicentre, international, open-label clinical study was conducted in patients with HER2-positive unresectable locally advanced breast cancer (LABC) or MBC who had received prior taxane and trastuzumab-based therapy, including patients who received prior therapy with trastuzumab and a taxane in the adjuvant setting and who relapsed during or within six months of completing adjuvant therapy.
Maltese: III, randomised, multiċentriku, internazzjonali u open-label fuq pazjenti b'kanċer tas-sider avanzat lokalment (LABC - locally advanced breast cancer), li ma jistax jitneħħa jew MBC pożittivi għal HER2 li kienu rċevew terapija minn qabel ibbażata fuq taxane u trastuzumab, inkluż pazjenti li rċevew terapija minn qabel b'trastuzumab u taxane fl-ambjent awżiljari u li rkadew matul jew fi żmien sitt xhur wara li lestew it-terapija awżiljarja.
English: Gastrointestinal disorders Stomatitis,
Maltese: Disturbi gastro-intestinali
English: All but 5 patients were women; 3 men were included in the trastuzumab arm and 2 in the trastuzumab emtansine arm. 22.5 percent of patients were enrolled in North America, 54.2% in Europe and 23.3% throughout the rest of the world.
Maltese: Il-pazjenti kollha minbarra 5 kienu nisa; 3 irġiel kienu inklużi fil-grupp ta' trastuzumab u 2 fil-grupp ta' trastuzumab emtansine. 22.5 fil-mija tal-pazjenti kienu rreġistrati fl-Amerika ta' Fuq, 54.2% fl-Ewropa u 23.3% madwar il-kumplament tad-dinja.
English: ADRs were reported using NCI-CTCAE for assessment of toxicity.
Maltese: L-ADRs kienu rrappurtati bl-użu ta' NCI-CTCAE għall-valutazzjoni tat-tossiċità.
English: Left ventricular ejection fraction (LVEF) < 40% has been observed in patients treated with trastuzumab emtansine, and therefore symptomatic congestive heart failure (CHF) is a potential risk (see section 4.8).
Maltese: Porzjon imbuttat 'il barra mill-ventrikolu tax-xellug (LVEF - left ventricular ejection fraction) ta' < 40% ġie osservat f'pazjenti ttrattati bi trastuzumab emtansine, u għalhekk insuffiċjenza konġestiva tal-qalb (CHF - congestive heart failure) sintomatika hija riskju potenzjali (ara sezzjoni 4.8).
English: Dose Modifications for Patients with MBC Adverse reaction Severity
Maltese: Modifikazzjonijiet fid-Doża għal Pazjenti b'EBC Reazzjoni avversa Severità
English: Grade 3 and 4 increased transaminases were reported in 1.5% of patients with EBC.
Maltese: Żidiet fittransaminases ta' Grad 3 u 4 kienu rrappurtati f'1.5% tal-pazjenti b'EBC.
English: Treatment of patients with hepatic impairment should be undertaken with caution (see sections 4.2 and 5.2).
Maltese: Ittrattament ta' pazjenti b'indeboliment epatiku għandu jsir b'attenzjoni (ara sezzjonijiet 4.2 u 5.2).
English: Kadcyla, trastuzumab emtansine, is a HER2-targeted antibody-drug conjugate which contains the humanised anti-HER2 IgG1, trastuzumab, covalently linked to the microtubule inhibitor DM1 (a maytansine derivative) via the stable thioether linker MCC (4-[N-maleimidomethyl] cyclohexane-1-carboxylate).
Maltese: DM1 (derivattiv ta' maytansine) permezz tal-molekula stabbli li teħel ma' thioether, MCC (4-[N-maleimidomethyl] cyclohexane-1-carboxylate).
English: Sodium chloride 4.5 mg/mL (0.45%) solution for infusion may be used without a polyethersulfone (PES) 0.20 or 0.22-μm in-line filter.
Maltese: Soluzzjoni għall-infużjoni ta' 4.5 mg/mL (0.45%) sodium chloride tista' tintuża mingħajr filtru fil-pajp ta' 0.20 jew 0.22-μm magħmul minn polyethersulfone (PES).
English: Patients with thrombocytopenia (≤ 100,000/mm3) and patients on anti-coagulant treatment (e.g. warfarin, heparin, low molecular weight heparins) should be monitored closely while on trastuzumab emtansine treatment.
Maltese: 3) u pazjenti fuq trattament kontra l-koagulazzjoni taddemm (eż. warfarin, heparin, heparins ta' piż molekulari baxx) għandhom jiġu mmonitorjati mill-qrib waqt li jkunu qed jirċievu trattament b'trastuzumab emtansine.
English: Hepatotoxicity, Hepatic failure, Nodular regenerative hyperplasia, Portal hypertension
Maltese: Tossiċità tal-fwied, Insuffiċjenza talfwied, Iperplasija riġenerattiva nodulari, Pressjoni portali għolja
English: Dyspepsia, Gingival
Maltese: Newtropenija, Lewkopenija
English: Grade 4 at any time < 25,000/mm3
Maltese: Grad 4 fi kwalunkwe ħin < 25,000/mm
English: Treatment of patients with hepatic impairment should be undertaken with caution due to known hepatotoxicity observed with trastuzumab emtansine (see section 4.4 and 5.2).
Maltese: It-trattament ta' pazjenti b'indeboliment epatiku għandu jsir b'attenzjoni minħabba epatotossiċità magħrufa osservata b'trastuzumab emtansine (ara sezzjoni 4.4 u 5.2).
English: Kadcyla contains the active substance trastuzumab emtansine, which is made up of two parts that are linked together: · trastuzumab - a monoclonal antibody that binds selectively to an antigen (a target protein) called human epidermal growth factor receptor 2 (HER2).
Maltese: • trastuzumab - antikorp monoklonali li jeħel b'mod selettiv ma' antiġen (proteina immirata) imsejħa ir-riċettur 2 tal-fattur tat-tkabbir epidermali uman (HER2 - human epidermal growth factor receptor 2).
English: The majority of the patients (76.9%) had received an anthracycline-containing neoadjuvant chemotherapy regimen.19.5% percent of patients received another HER2-targeted agent in addition to trastuzumab as a component of neoadjuvant therapy; 93.8% of these patients received pertuzumab.
Maltese: 19.5% tal-pazjenti kienu rċevew sustanza oħra mmirata lejn HER2 flimkien ma' trastuzumab bħala komponent ta' terapija neoawżiljarja; 93.8% ta' dawn il-pazjenti rċevew pertuzumab.
English: Kadcyla (trastuzumab emtansine) and Herceptin (trastuzumab) are two very different products with different active substances never to be used interchangeably.
Maltese: Kadcyla (trastuzumab emtansine) u Herceptin (trastuzumab) huma żewġ prodotti differenti ħafna b'sustanzi attivi differenti li qatt m'għandhom jintużaw minflok xulxin.
English: · The first infusion will be given to you over 90 minutes.
Maltese: Id-doża tal-bidu għandha tingħata bħala infużjoni fil-vini ta' 90 minuta.
English: Another rare abnormality that can occur in the liver is a condition known as nodular regenerative hyperplasia (NRH).
Maltese: Anormalità rari oħra li tista' sseħħ fil-fwied hija kondizzjoni magħrufa bħala iperplasija nodulari riġenerattiva (NRH - nodular regenerative hyperplasia).
English: No reproductive and developmental toxicology studies have been conducted with trastuzumab emtansine.
Maltese: Ma sarux studji dwar it-tossiċità fuq is-sistema riproduttiva u l-iżvilupp b'trastuzumab emtansine.
English: Peripheral neuropathy, mainly as Grade 1 and predominantly sensory, was reported in clinical trials of trastuzumab emtansine.
Maltese: Newropatija periferali, l-aktar ta' Grad 1 u fil-biċca l-kbira sensorjali, kienet irrappurtata fi studji kliniċi bi trastuzumab emtansine.
English: In a sensitivity analysis censoring patients at the time of cross-over, the hazard ratio was 0.69 (95% CI 0.59, 0.82).
Maltese: F'analiżi tas-sensittività li tiċċensura pazjenti meta jaqilbu, il-proporzjon ta' periklu kien ta' 0.69 (CI ta' 95% 0.59, 0.82).
English: In clinical studies, the incidence and severity of thrombocytopenia were higher in Asian patients (see section 4.8).
Maltese: Fi studji kliniċi, l-inċidenza u s-severità ta' tromboċitopenija kienu ogħla f'pazjenti Asjatiċi (ara sezzjoni 4.8).
English: Infusion-related reactions were reported in 1.6% of patients with EBC, with no Grade 3 or 4 events reported.
Maltese: Reazzjonijiet relatati mal-infużjoni kienu rrappurtati f'1.6% tal-pazjenti b'EBC, bl-ebda rapport ta' avvenimenti ta' Grad 3 jew 4.
English: Left ventricular dysfunction was reported in 2.2% of patients in MBC clinical studies with trastuzumab emtansine.
Maltese: Disfunzjoni tal-ventrikolu tax-xellug kienet irrappurtata fi 2.2% tal-pazjenti b'MBC fl-istudji kliniċi dwar MBC b'trastuzumab emtansine.
English: In the event of decreased platelet count to Grade 3 or greater (< 50,000/mm3), do not administer trastuzumab emtansine until platelet counts recover to Grade 1 (≥ 75,000/mm3) (see section 4.2).
Maltese: F'każ ta' għadd ta' plejtlits imnaqqas għal Grad 3 jew aktar (< 50,000/mm 3), tagħtix trastuzumab emtansine qabel ma l-għadd tal-plejtlits jirkupra għal Grad 1 (≥ 75,000/mm 3) (ara sezzjoni 4.2).
English: How to store Kadcyla
Maltese: X'fih Kadcyla
English: Kadcyla 160 mg powder for concentrate for solution for infusion Kadcyla is provided in 20 mL (160 mg) Type 1 glass vial closed with a grey-butyl rubber stopper coated with fluoro resin laminate, and sealed with an aluminium seal with a purple plastic flip-off cap.
Maltese: Kadcyla huwa pprovdut f'kunjett tal-ħġieġ tat-Tip 1 ta' 20 mL (160 mg) magħluq b'tapp griż tallastku butyl miksi b'kisja ta' fluoro-resin, u ssiġillat b'siġill tal-aluminju b'għatu tal-plastik vjola li jitqaċċat.
English: Glucose (5%) solution should not be used Sodium chloride 4.5 mg/mL (0.45%) solution for infusion may be used without a polyethersulfone (PES) 0.20 or 0.22-μm in-line filter.
Maltese: M'għandhiex tintuża soluzzjoni ta' glucose (5%). Soluzzjoni għall-infużjoni ta' 4.5 mg/mL (0.45%) sodium chloride tista' tintuża mingħajr filtru fil-pajp ta' 0.20 jew 0.22-μm magħmul minn polyethersulfone (PES).
English: The MAH shall agree the content and format of the Kadcyla (trastuzumab emtansine) educational material and a communication plan with the National Competent Authority in the Member State before Kadcyla (trastuzumab emtansine) is launched in each Member State.
Maltese: L-MAH għandu jiftieħem dwar il-kontenut u d-dehra tal-materjal edukattiv ta' Kadcyla (trastuzumab emtansine) u dwar pjan ta' komunikazzjoni mal-Awtorità Nazzjonali Kompetenti fl-Istat Membru qabel Kadcyla (trastuzumab emtansine) titqiegħed fis-suq f'kull Stat Membru.
English: Upon binding to HER2, trastuzumab emtansine undergoes receptor-mediated internalization and subsequent lysosomal degradation, resulting in release of DM1-containing cytotoxic catabolites (primarily lysine-MCC-DM1).
Maltese: Meta jeħel ma' HER2, trastuzumab emtansine jgħaddi minn internalizzazzjoni medjata mir-riċettur u wara dan degradazzjoni mil-lisosomi, li twassal għal reħa ta' kataboliti ċitotossiċi li fihom DM1 (primarjament lysine-MCC-DM1).
English: Trastuzumab emtansine was given intravenously at 3.6 mg/kg on Day 1 of a 21-day cycle.
Maltese: Trastuzumab emtansine ngħata fil-vini b'doża ta' 3.6 mg/kg fil-Jum 1 ta' ċiklu ta' 21 jum.