FrancophonIA/ELRC3.0 huggingface dataset:
English: Each 420mg vial of KANJINTI is reconstituted with 20 mL of sterile water for injections (not supplied).
Maltese: Kull kunjett ta' KANJINTI 420 mg huwa rikostitwit b'20 mL ta' ilma għall-injezzjoni sterili (mhux ipprovdut).
English: Patients who had previously received anthracycline-based adjuvant chemotherapy were treated with paclitaxel (175 mg/m2 infused over 3 hours) with or without trastuzumab.
Maltese: Pazjenti li qabel kienu rċevew kimoterapija awżiljarja bbażata fuq anthracycline kienu ttrattati b'paclitaxel (175 mg/m2 mogħti bħala infużjoni fuq medda ta' 3 sigħat) bi jew mingħajr trastuzumab.
English: Hypoprothrombinaemia
Maltese: Ipoprotrombinemija
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 B-31 u NCCTG N9831.
English: 1Heart beat irregular
Maltese: 1Taħbit tal-qalb irregolari
English: The efficacy results from the BCIRG 006 are summarised in Tables 9 and 10.
Maltese: Ir-riżultati tal-effikaċja minn BCIRG 006 huma miġbura fil-qosor f'Tabelli 9 u 10.
English: Hazard Ratio versus AC→P (95% CI)
Maltese: Proporzjon ta' Periklu kontra AC→P (CI ta' 95%)
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-positive MBC, suggested that concomitant administration of trastuzumab had no effect on the single dose pharmacokinetics of docetaxel.
Maltese: Data minn studju JP16003, studju bi grupp wieħed ta' trastuzumab (doża għolja tal-bidu ta' 4 mg/kg fil-vini u 2 mg/kg fil-vini kull ġimgħa) u docetaxel (60 mg/m2 fil-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: In the neoadjuvant-adjuvant treatment setting, study MO16432, a multicentre randomised trial, was designed to investigate the clinical efficacy of concurrent administration of trastuzumab with neoadjuvant chemotherapy including both an anthracycline and a taxane, followed by adjuvant trastuzumab, up to a total treatment duration of 1 year.
Maltese: F'ambjent ta' trattament neoawżiljarju-awżiljarju, l-istudju MO16432, prova randomized b'aktar minn ċentru wieħed, kienet maħsuba biex tinvestiga l-effikaċja klinika ta' għoti ta' trastuzumab flimkien ma' kimoterapija neoawżiljarja inkluż kemm anthracycline kif ukoll taxane, segwit minn trastuzumab awżiljarju, sa tul ta' trattament totali ta' sena.
English: Pre-medication may be used to reduce risk of occurrence of these events.
Maltese: Medikazzjoni minn qabel tista' tintuża biex jitnaqqas ir-riskju ta' okkorrenza ta' dawn l-avvenimenti.
English: • dizziness
Maltese: • konġuntivite
English: In the pivotal trial BO22227, trastuzumab was administered concurrently with neoadjuvant chemotherapy that contained four cycles of epirubicin (cumulative dose 300 mg/m2); at a median follow-up exceeding 70 months, the incidence of cardiac failure/congestive cardiac failure was 0.3% in the trastuzumab intravenous arm.
Maltese: BO22227, trastuzumab ingħata flimkien ma' kimoterapija neoawżiljarja li kien fiha erba' ċikli ta' epirubicin (doża kumulattiva ta' 300 mg/m2); waqt segwitu medjan li jaqbeż 70 xahar, linċidenza ta' insuffiċjenza tal-qalb/insuffiċjenza konġestiva tal-qalb kienet ta' 0.3% fil-grupp ta' trastuzumab fil-vini.
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, pnewmonja, pulmonite, effużjoni fil-plewra, distress respiratorju, edima pulmonari akuta u insuffiċjenza respiratorja (ara sezzjoni 4.4).
English: Accurate and validated assay methods should be used (see sections 4.4 and 5.1).
Maltese: Għandhom jintużaw metodi ta' analiżi preċiżi u ġġustifikati (ara sezzjonijiet 4.4 u 5.1).
English: Paraesthesia
Maltese: Parasteżija
English: Do not use with glucose-containing solutions.
Maltese: Tużax ma' soluzzjonijiet li fihom il-glucose.
English: Monoclonal antibodies attach to specific proteins or antigens.
Maltese: Antikorpi monoklonali jeħlu ma' proteini jew antiġeni speċifiċi.
English: In the neoadjuvant setting, the experience of concurrent administration of trastuzumab and low dose anthracycline regimen is limited (see section 4.4).
Maltese: Fl-ambjent neoawżiljarju, l-esperjenza tal-għoti ta' trastuzumab flimkien ma' kors ta' doża baxxa ta' anthracycline hija limitata (ara sezzjoni 4.4).
English: • bruising
Maltese: • sturdament
English: Trastuzumab is designed to bind selectively to an antigen called human epidermal growth factor receptor 2 (HER2).
Maltese: Trastuzumab huwa ddisinjat biex jeħel b'mod selettiv ma' antiġen imsejjaħ riċettur tal-fattur tat-tkabbir epidermali uman 2 (HER2 - human epidermal growth factor receptor 2).
English: Distant recurrence No. patients with event p = 0.0008
Maltese: Numru ta' pazjenti blavveniment p = 0.0008
English: The presence of anti-trastuzumab antibodies had no impact on the 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: Haematotoxicity
Maltese: Tossiċità ematoloġika
English: Median duration of response (months) (range) Median TTP (months) (95%CI)
Maltese: Rata ta' Respons (CI ta' 95%) Tul medjan tarrispons (xhur) (CI ta' 95%)
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: In the NSABP B-31 and NCCTG N9831 studies trastuzumab was administered in combination with paclitaxel, following AC chemotherapy.
Maltese: Fl-istudji NSABP B-31 u NCCTG N9831 trastuzumab ingħata flimkien ma' paclitaxel, wara kimoterapija AC.
English: +Anaphylactic reaction
Maltese: +Reazzjoni anafilattika
English: 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: Il-ammont xieraq ta' soluzzjoni għandu jittella' mill-kunjett u jiżdied ma' borża tal-infużjoni li fiha 250 mL ta' soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9%) sodium chloride.
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, disturbi fir-ritmu tal-qalb (palpitazzjonijiet, ritmu mhux normali tal-qalb jew taħbit irregolari tal-qalb), nefħa tal-wiċċ u x-xufftejn, raxx u tħossok għajjien/a.
English: Amongst the most serious and/or common adverse reactions reported in trastuzumab 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' trastuzumab hemm disfunzjoni kardijaka, reazzjonijiet relatati mal-infużjoni, tossiċità ematoloġika (b'mod partikolari newtropenija), infezzjonijiet u reazzjonijiet pulmonari avversi.
English: • acute accumulation of fluid in the lungs
Maltese: • akkumulazzjoni akuta ta' fluwidu fil-pulmun
English: Infection
Maltese: Disġewżja
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 ttrattati b'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 malmediċini l-oħra għall-kanċer capecitabine jew 5-fluorouracil u cisplatin.
English: In the ToGA (BO18255) trial, patients whose tumours were either IHC3+ or FISH positive were defined as HER2 positive and thus included in the trial.
Maltese: Fil-prova ToGA (BO18255), pazjenti li t-tumuri tagħhom kienu pożittivi għal IHC3+ jew għal FISH, kienu definiti bħala pożittivi għal HER2 u għalhekk kienu nklużi fil-prova.
English: Hazard Ratio vs AC→P (95% CI) p-value
Maltese: Proporzjon ta' Periklu kontra AC→P (CI ta' 95%) valur p
English: Table 1 Undesirable effects reported with intravenous trastuzumab monotherapy or in combination with chemotherapy in pivotal clinical trials (N = 8,386) and in post-marketing
Maltese: Effetti mhux mixtieqa rrappurtati b'trastuzumab fil-vini bħala monoterapija jew flimkien ma' kimoterapija fi provi kliniċi pivitali (N = 8,386) u wara t-tqegħid fis-suq
English: • capecitabine - 1,000 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 - 1,000 mg/m2 orali darbtejn kuljum għal 14-il ġurnata kull 3 ġimgħat għal 6 ċikli
English: Children and adolescents KANJINTI is not recommended for anyone under the age of 18 years.
Maltese: Tfal u adolexxenti KANJINTI mhux rakkomandat għall-persuni b'età inqas minn 18-il sena.
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: Disease-free survival - No. patients with event - No. patients without event P-value versus Observation Hazard Ratio versus Observation Recurrence-free survival - No. patients with event - No. patients without event P-value versus Observation Hazard Ratio versus Observation Distant disease-free survival - No. patients with event - No. patients without event P-value versus Observation Hazard Ratio versus Observation Overall survival (death) - No. patients with event - No. patients without event P-value versus Observation Hazard Ratio versus Observation
Maltese: Sopravivenza mingħajr il-marda - Numru ta' pazjenti blavveniment - Numru ta' pazjenti mingħajr l-avveniment Valur p kontra Osservazzjoni Proporzjoni ta' Periklu kontra Osservazzjoni Sopravivenza mingħajr ma terġa toħroġ il-marda - Numru ta' pazjenti blavveniment - Numru ta' pazjenti mingħajr l-avveniment Valur p kontra Osservazzjoni Proporzjoni ta' Periklu kontra Osservazzjoni Sopravivenza mingħajr metastasi - Numru ta' pazjenti blavveniment - Numru ta' pazjenti mingħajr l-avveniment Valur p kontra Osservazzjoni Proporzjoni ta' Periklu kontra Osservazzjoni Sopravivenza globali (mewt) - Numru ta' pazjenti blavveniment - Numru ta' pazjenti mingħajr l-avveniment Valur p kontra Osservazzjoni Proporzjoni ta' Periklu kontra Osservazzjoni
English: How to store KANJINTI
Maltese: X'fih KANJINTI
English: KANJINTI 150 mg powder for concentrate for solution for infusion
Maltese: KANJINTI 150 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: Glomerulonephritis membranous Not known Glomerulonephropathy
Maltese: Glomerulonefrite membranuża
English: In patients with EBC eligible for neoadjuvant-adjuvant treatment, KANJINTI should be used concurrently with anthracyclines only in chemotherapy-naive patients and only with low-dose anthracycline regimens i.e. maximum cumulative doses of doxorubicin 180 mg/m2 or epirubicin 360 mg/m2.
Maltese: F'pazjenti b'EBC eliġibbli għal trattament neoawżiljarju-awżiljarju, KANJINTI għandu jintuża flistess waqt ma' anthracyclines biss f'pazjenti li qatt ma ħadu kimoterapija qabel u biss b'korsijiet b'doża baxxa ta' anthracycline jiġifieri dożi kumulattivi massimi ta' doxorubicin 180 mg/m2 jew epirubicin 360 mg/m2.
English: 12 weeks.
Maltese: Tabella 12.
English: Headache
Maltese: Sirdat
English: This yields a 7.4 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab.
Maltese: Dan jagħti soluzzjoni ta' 7.4 mL għall-użu ta' doża waħda, li fih madwar 21 mg/mL ta' trastuzumab.
English: The loading dose should be administered as a 90-minute intravenous infusion.
Maltese: Id-doża ogħla tal-bidu għandha tingħata bħala infużjoni filvini fuq medda ta' 90 minuta.
English: KANJINTI 150 mg powder for concentrate for solution for infusion KANJINTI 420 mg powder for concentrate for solution for infusion trastuzumab
Maltese: KANJINTI 150 mg trab għal konċentrat għal soluzzjoni għall-infużjoni KANJINTI 420 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: Hazard Ratio vs AC→D (95% CI)
Maltese: Proporzjon ta' Periklu kontra AC→D (CI ta' 95%)
English: 2+ A weak to moderate complete membrane staining is detected in > 10% of the tumour cells.
Maltese: Tebgħa kompluta ħafifa sa moderata fil-membrana osservata f'> 10% taċ-ċelluli tat-tumur.
English: Onychoclasis
Maltese: Onikoklażi
English: Immune thrombocytopenia
Maltese: Glomerulonefropatija
English: The final OS results from the joint analysis of studies NSABP B-31 and NCCTG N9831 are summarised in table 8:
Maltese: Ir-riżultati finali ta' OS mill-analiżi konġunta tal-istudji NSABP B-31 u NCCTG N9831 huma miġbura fil-qosor f'tabella 8 taħt:
English: KANJINTI 420 mg powder for concentrate for solution for infusion
Maltese: KANJINTI 420 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: • tremor
Maltese: • suffejra
English: The bioactivity of D7D and the clinical impact of the elevation of this metabolite was unclear.
Maltese: Il-bioattività ta' D7D u l-impatt kliniku tal-elevazzjoni ta' dan il-metabolit ma kinux ċari.
English: Pharyngitis
Maltese: FARMAĊEWTIKU
English: Cardiomyopathy
Maltese: Kardjomijopatija
English: Early breast cancer (neoadjuvant-adjuvant setting)
Maltese: Kanċer bikri tas-sider (ambjent neoawżiljarju-awżiljarju)
English: KANJINTI 150 mg powder for concentrate for solution for infusion 20 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film and aluminium seal flip-off dust cover containing 150 mg of trastuzumab.
Maltese: U KWANTITATTIVA KANJINTI 150 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Kunjett wieħed fih 150 mg ta' trastuzumab, antikorp monoklonali
English: • cough
Maltese: • xokk
English: Reactions include chills, fever, dyspnoea, hypotension, wheezing, bronchospasm, tachycardia, reduced oxygen saturation, respiratory distress, rash, nausea, vomiting and headache (see section 4.4).
Maltese: Ir-reazzjonijiet jinkludu, sirdat, deni, qtugħ ta' nifs, pressjoni baxxa, tħarħir, bronkospażmu, takikardija, saturazzjoni ta' ossiġnu mnaqqsa, distress respiratorju, raxx, tqalligħ, rimettar, u uġigħ ta' ras (ara sezzjoni 4.4).
English: In patients with EBC an increase in the incidence of symptomatic and asymptomatic cardiac events was observed when trastuzumab was administered after anthracycline-containing chemotherapy compared to administration with a non-anthracycline regimen of docetaxel and carboplatin and was more marked when trastuzumab was administered concurrently with taxanes than when administered sequentially to taxanes.
Maltese: F'pazjenti b'EBC kienet osservata żieda fl-inċidenza ta' avvenimenti kardijaċi sintomatiċi u mhux sintomatiċi meta trastuzumab ingħata wara kimoterapija li fiha anthracycline meta mqabbel ma' għoti flimkien ma' kors ta' docetaxel u carboplatin li ma fihx anthracycline u kienet aktar evidenti meta trastuzumab ingħata flimkien ma' taxanes milli meta ingħata wara taxanes.
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' 2°C - 8°C fil-friġġ.
English: Strong complete, basolateral or lateral membranous reactivity in ≥ 10% of tumour cells
Maltese: Reattività qawwija, kompluta, bażolaterali jew laterali filmembrana f'≥ 10% taċ-ċelluli tat-tumur.
English: Neutropenic sepsis
Maltese: Sepsi newtropenika
English: Mucosal inflammation
Maltese: Disturbi psikjatriċi
English: Death (OS event) No. patients with event p < 0.0001
Maltese: Mewt (avveniment OS): Numru ta' pazjenti blavveniment p < 0.0001
English: Jaundice
Maltese: Kors
English: CLINICAL PARTICULARS 4.1 Therapeutic indications Breast cancer Metastatic breast cancer KANJINTI 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: KANJINTI huwa indikat għat-trattament ta' pazjenti adulti b'kanċer metastatiku tas-sider (MBCmetastatic breast cancer) pożittiv għal HER2:
English: Aseptic preparation, handling and storage:
Maltese: Preparazzjoni, immaniġġjar u ħażna asettiċi:
English: Traceability
Maltese: Traċċabbiltà
English: Monitoring may help to identify patients who develop cardiac dysfunction.
Maltese: Il-monitoraġġ jista' jgħin biex ikunu identifikati pazjenti li jiżviluppaw disfunzjoni kardijaka.
English: KANJINTI 420 mg powder for concentrate for solution for infusion 50 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film and aluminium seal flip-off dust cover containing 420 mg of trastuzumab.
Maltese: KANJINTI 420 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Kunjett wieħed fih 420 mg ta' trastuzumab, antikorp monoklonali
English: • abnormal heart rhythm
Maltese: • ritmu tal-qalb mhux normali
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' trattament 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: Table 16 Population predicted PK parameter values at steady-state for trastuzumab intravenous dosing regimens in MBC, EBC and AGC patients
Maltese: Valuri mbassra tal-parametru PK tal-popolazzjoni fi stat fiss għal korsijiet ta' dożaġg ta' trastuzumab fil-vini f'pazjenti b'MBC, EBC u AGC
English: Details of risk minimisation measures that are consistent with the EU Risk Management Plan are presented in “Warnings and precautions” (see section 4.4).
Maltese: Dettalji ta' miżuri ta' minimizzazzjoni tar-riskji li huma konsistenti mal-Pjan tal-Ġestjoni tar-Riskju tal-UE huma ppreżentati fi “Twissijiet speċjali u prekawzjonijiet għall-użu” (ara sezzjoni 4.4).
English: AGC.
Maltese: Ħakk
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: The median duration of follow-up was 2.9 years in the AC→D arm and 3.0 years in each of the AC→DH and DCarbH arms.
Maltese: It-tul medjan ta' segwitu kien ta' 2.9 snin fil-grupp AC→D u ta' 3.0 snin fil-gruppi AC→DH u DCarbH.
English: • abnormally low oxygen levels in the blood
Maltese: • livelli għolja ta' pottassju
English: KANJINTI should not be diluted with glucose solutions since these cause aggregation of the protein.
Maltese: KANJINTI m'għandux jiġi dilwit b'soluzzjonijiet ta' glucose għaliex dawn jistgħu jikkawżaw aggregazzjoni tal-proteina.
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: Orthopnoea
Maltese: Eċċimosi
English: Disease-free survival No. patients with event (%)
Maltese: Numru ta' pazjenti blavveniment (%)
English: If you receive KANJINTI 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: KANJINTI flimkien ma' xi mediċina oħra għat-trattament tal-kanċer, bħal paclitaxel, docetaxel, inibitur ta' aromatase, capecitabine, 5-fluorouracil, jew cisplatin, għandek taqra wkoll ilfuljett ta' tagħrif għal dawn il-prodotti.
English: - in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.
Maltese: - flimkien ma' kimoterapija awżiljarja li tikkonsisti minn docetaxel u carboplatin.
English: • You have early breast cancer, with high levels of a protein called HER2.
Maltese: • Għandek kanċer bikri tas-sider, b'livelli għolja ta' proteina msejħa HER2.
English: General considerations
Maltese: Konsiderazzjonijiet ġenerali
English: If possible, physicians should avoid anthracycline-based therapy for up to 7 months after stopping KANJINTI.
Maltese: Jekk possibbli, it-tobba għandhom jevitaw terapija bbażata fuq anthracycline għal sa 7 xhur wara l-waqfien ta' KANJINTI.
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' trattament b'trastuzumab komplew fuq it-terapija mingħajr aktar avvenimenti kardijaċi kliniċi.
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: The efficacy results from the joint analysis of the NSABP B-31 and NCCTG N9831 trials at the time of the definitive analysis of DFS* are summarised in Table 7.
Maltese: Ir-riżultati tal-effikaċja mill-analiżi konġunta tal-provi NSABP B-31 u NCCTG N9831 fil-ħin talanaliżi definittiva ta' DFS* huma miġbura fil-qosor f'Tabella 7.
English: Clinically significant interactions between trastuzumab and the concomitant medicinal products used in clinical trials have not been observed.
Maltese: Ma kinux osservati interazzjonijiet klinikament sinifikanti bejn trastuzumab u l-prodotti mediċinali mogħtija fl-istess waqt użati fil-provi kliniċi.
English: • prepared in a laminar flow hood or biological safety cabinet using standard precautions for the safe handling of intravenous agents.
Maltese: • tiġi ppreparata f'kabinett ta' fluss laminari jew armarju tas-sigurtà bijoloġika bl-użu tal prekawzjonijiet standard għall-immaniġġjar sikur ta' sustanzi għall-użu fil-vini.
English: • jaundice
Maltese: • dardir