FrancophonIA/ELRC3.0 huggingface dataset:
English: Lapatinib is predominantly eliminated through metabolism by CYP3A4/5.
Maltese: Lapitinib huwa l-biċċa l-kbira eliminat permezz tal-metaboliżmu minn CYP3A4/5.
English: The safety of lapatinib has been evaluated as monotherapy or in combination with other chemotherapies for various cancers in more than 20,000 patients, including 198 patients who received lapatinib in combination with capecitabine, 149 patients who received lapatinib in combination with trastuzumab and 654 patients who received lapatinib in combination with letrozole (see section 5.1).
Maltese: Is-sigurtà ta' lapatinib ġiet evalwata bħala monoterapija jew flimkien ma' kimoterapiji oħra għal diversi kankri f'aktar minn 20,000 pazjent, inkluż 198 pazjenti li rċievew lapatinib flimkien ma' capecitabine, 149 pazjent li rċevew lapatinib flimkien ma' trastuzumab u 654 pazjent li rċevew lapatinib flimkien ma' letrozole (ara sezzjoni 5.1).
English: Measurements, including electrocardiograms (ECGs) and pharmacokinetic samples, were taken at baseline and at the same time points on Day 2 and Day 4.
Maltese: Il-kejl, inklużi elettrokardjogrammi (ECGs - electrocardiograms) u kampjuni farmakokinetiċi, ittieħdu fil-linja bażi u fl-istess punti ta' żmien f'Jum 2 u Jum 4.
English: Lapatinib, a 4-anilinoquinazoline, is an inhibitor of the intracellular tyrosine kinase domains of both EGFR (ErbB1) and of HER2 (ErbB2) receptors (estimated Ki app values of 3nM and 13nM, respectively) with a slow off-rate from these receptors (half-life greater than or equal to 300 minutes).
Maltese: Lapatinib li huwa 4-anilinoquinazoline, huwa impeditur ta' l-unitajiet globulari kemm tar-riċetturi EGFR (ErbB1) kif ukoll HER2 (ErbB2) (valuri Ki app stmati ta' 3nM u 13nM, rispettivament) ta' tyrosine kinase intraċellulari li jinħall bil-mod minn dawn ir-riċetturi (half-life aktar minn jew ta' 300 minuta).
English: †, cough
Maltese: 1, xhur
English: Tyverb 1500 mg / day + Letrozole 2.5 mg /day
Maltese: Tyverb 1500 mg / ġurnata + Letrozole 2.5 mg / ġurnata
English: Lapatinib did not significantly inhibit the following enzymes in human liver microsomes: CYP1A2, CYP2C9, CYP2C19, and CYP2D6 or UGT enzymes (in vitro IC50 values were greater than or equal to 6.9 µg/ml).
Maltese: CYP1A2, CYP2C9, CYP2C19, u CYP2D6 jew enzimi UGT (valuri IC50 in vitro kienu aktar minn jew ekwivalenti għal 6.9 µg/ml).
English: Patients were randomised to receive either oral lapatinib 1000 mg once daily plus trastuzumab 4 mg/kg administered as an intravenousloading dose, followed by 2 mg/kg intravenous weekly (N = 148), or oral lapatinib 1500 mg once daily (N = 148).
Maltese: Il-pazjenti kienu randomizzati sabiex jirċievu jew lapatinib orali 1000 mg darba kuljum flimkien ma' trastuzumab 4 mg/kg mogħti bħala loading dose fil-vini, segwit minn 2 mg/kg fil-vini kull ġimgħa (N = 148), jew lapatinib orali 1500 mg darba kuljum (N = 148).
English: Co-administration of Tyverb with strong inhibitors of CYP3A4 (e.g. ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole, nefazodone) should be avoided.
Maltese: (e.ż. ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole, nefazodone) għandha tiġi evitata.
English: Lapatinib inhibits CYP2C8 in vitro at clinically relevant concentrations.
Maltese: Lapatinib jimpedixxi CYP2C8 in vitro f'konċentrazzjonijiet klinikament rilevanti.
English: The results for the pharmacodynamics population (n=52) were consistent with those from the evaluable population (maximum ΔΔQTcF (90% CI) of 7.91 ms (4.13, 11.68) observed 10 hours after ingestion of the third dose of lapatinib 2000 mg).
Maltese: Ir-riżultati għall-popolazzjoni farmakodinamika (n=52) kienu konsistenti ma' dawk millpopolazzjoni li setgħet tiġi evalwata (ΔΔQTcF massimu (CI ta' 90%) ta' 7.91 ms (4.13, 11.68) osservat 10 siegħa wara l-inġestjoni tat-tielet doża ta' lapatinib 2000 mg).
English: Diarrhoea occurred in approximately 65 % of patients who received lapatinib in combination with capecitabine, in 64 % of patients who received lapatinib in combination with letrozole and in 62 % of patients who received lapatinib in combination with trastuzumab.
Maltese: Kien hemm dijarea f'bejn wieħed u ieħor 65 % tal-pazjenti li rċievew kura b'lapatinib flimkien ma' capecitabine, f'64 % tal-pazjenti li rċevew lapatinib flimkien ma' letrozole u fi 62 % tal-pazjenti li rċevew lapatinib flimkien ma' trastuzumab.
English: The cumulative frequency in DQA1*02:01 and DRB1*07:01 allele carriers was 10.3% and in non-carriers was 0.5%.
Maltese: Il-frekwenza kumulattiva f'dawk li jġorru l-alleles DQA1*02:01 u DRB1*07:01 kienet ta' 10.3 % u f'dawk li ma jġorrux l-alleles kienet ta' 0.5 %.
English: Other medicines and Tyverb
Maltese: Mediċini oħra u Tyverb
English: Rash occurred in approximately 28 % of patients who received lapatinib in combination with capecitabine, in 45 % of patients who received lapatinib in combination with letrozole and in 23 % of patients who received lapatinib in combination with trastuzumab.
Maltese: Kien hemm raxx f'bejn wieħed u ieħor 28 % tal-pazjenti li rċievew kura b'lapatinib flimkien ma' capecitabine, f'45 % tal-pazjenti li rċevew lapatinib flimkien ma' letrozole u fi 23 % tal-pazjenti li rċevew lapatinib flimkien ma' trastuzumab.
English: Less than 2% of the administered oral dose (as lapatinib and metabolites) excreted in urine.
Maltese: Anqas minn 2 % tad-doża orali amministrata (bħala lapatinib u sustanzi tal-metaboliżmu) titneħħa flawrina.
English: LVEF decreases were reported in 6.7 % of patients who received lapatinib in combination with trastuzumab, as compared to 2.1 % of patients who received lapatinib alone.
Maltese: Tnaqqis fl-LVEF kien irrappurtat f'6.7 % tal-pazjenti li rċevew lapatinib flimkien ma' trastuzumab, meta mqabbel ma' 2.1 % tal-pazjenti li rċevew lapatinib waħdu.
English: When lapatinib is taken in combination with strong CYP3A4 inhibitors the QTc interval can be expected to be prolonged by 16.1 ms (12.6-20.3 ms) as demonstrated in a model-based prediction (see section 4.4).
Maltese: Meta lapatinib jittieħed flimkien ma' inibituri qawwija ta' CYP3A4 l-intervall tal-QTc jista' jkun mistenni li jittawwal b'16.1 ms (12.6-20.3 ms) kif muri waqt tbassir imsejjes fuq mudell (ara sezzjoni 4.4).
English: Gastrointestinal disorders Very common Diarrhoea, which may lead to dehydration (see section 4.2 - dose delay and dose reduction - other toxicities and section 4.4), nausea, vomiting, dyspepsia*, stomatitis*, constipation*, abdominal pain*.
Maltese: Dijarea, li tista' twassal għal deidratazzjoni (ara sezzjoni 4.2posponiment tad-doża u tnaqqis fid-doża - tossiċitajiet oħra u sezzjoni 4.4), dardir, rimettar, dispepsja*, stomatite*, stitikezza*, uġigħ addominali*.
English: There is no specific antidote for the inhibition of EGFR (ErbB1) and/or HER2 (ErbB2) tyrosine phosphorylation.
Maltese: M'hemm l-ebda antidot speċifiku għall-impediment ta' l-introduzzjoni tal-grupp fosfat f'tyrosine ta' EGFR (ErbB1) u/jew HER2 (ErbB2).
English: • in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting (see section 5.1).
Maltese: • flimkien ma capecitabine għall-pazjenti b'kanċer avanzat tas-sider jew marda metastatika bi progressjoni wara li tkun diġà ingħatat terapija, li kienet tinkludi anthracyclines u taxanes u terapija bi trastuzumab fi sfond ta' metastasi (ara sezzjoni 5.1).
English: In a large, randomised clinical trial of Tyverb monotherapy (n=1,194), the cumulative frequency of severe liver injury (ALT >5 times the upper limit of normal, NCI CTCAE grade 3) at 1 year of treatment was 2.8% overall.
Maltese: Fi studju kliniku każwali kbir, ta' monoterapija b'Tyverb (n = 1,194), il-frekwenza kumulattiva ta' ħsara qawwija fil-fwied (ALT > 5 darbiet l-ogħla limitu tan-normal, NCI CTCAE grad 3) wara l-ewwel sena ta' kura kienet ta' 2.8 % globalment.
English: Lapatinib was studied in pregnant rats and rabbits given oral doses of 30, 60, and 120 mg/kg/day.
Maltese: Lapainib kien studjat f'firien u fniek tqal li ingħatawlhom dożi orali ta' 30, 60, u 120 mg/kg/kuljum.
English: Table 4 Progression-free survival and overall survival data (Tyverb / trastuzumab)
Maltese: Tabella 4 Sopravivenza mingħajr progressjoni tal-marda u dejta dwar is-sopravivenza globali (Tyverb / trastuzumab)
English: • drink plenty of fluids (8 to 10 glasses a day), such as water, sports drinks or other clear liquids
Maltese: • ixrob ħafna fluwidi (8 sa 10 tazzi kuljum), bħall-ilma, xarbiet tal-isports jew likwidi ċari oħrajn
English: Co-administration of Tyverb with irinotecan (when administered as part of the FOLFIRI regimen) resulted in an approximate 40% increase in the AUC of SN-38, the active metabolite of irinotecan.
Maltese: FOLFIRI) irriżulta f'żieda ta' bejn wieħed u ieħor 40 % fl-AUC ta' SN-38, il-metabolit attiv ta' irinotecan.
English: In healthy volunteers receiving carbamazepine, a CYP3A4 inducer, at 100 mg twice daily for 3 days and 200 mg twice daily for 17 days, systemic exposure to lapatinib was decreased approximately 72%.
Maltese: F'voluntiera b'saħħithom li kienu qed jirċievu carbamazepine, induttur ta' CYP3A4, f'doża ta' 100 mg darbtejn kuljum għal 3 ijiem u 200 mg darbtejn kuljum għal 17-il ġurnata, esponiment sistemiku għal lapatinib naqas bejn wieħed u ieħor 72 %.
English: LVEF decreases were reported in 2.5 % of patients who received lapatinib in combination with capecitabine, as compared to 1.0 % with capecitabine alone.
Maltese: Tnaqqis fl-LVEF kien irrappurtat f'2.5 % tal-pazjenti li rċievew lapatinib flimkien ma' capecitabine, meta mqabbla ma' 1.0 % b'capacitabine waħdu.
English: In a single case of a patient who took 9000 mg of Tyverb, sinus tachycardia (with otherwise normal ECG) was also observed.
Maltese: F'każ wieħed fejn pazjent ħa 9000 mg ta' Tyverb, kien ukoll osservat sinus takikardja (mill-bqija b'ECG normali).
English: capecitabine (2500 mg/m2/day, days 1-14 q21 days)
Maltese: Capecitabine (2500 mg/m2/ġurnata, ġranet 1-14 kull 21 ġurnata)
English: In the evaluable population (n=37), the maximum mean ΔΔQTcF (90% CI) of 8.75 ms (4.08, 13.42) was observed 10 hours after ingestion of the third dose of lapatinib 2000 mg.
Maltese: Fil-popolazzjoni li setgħet tiġi evalwata (n=37), il-medja massima ta' ΔΔQTcF (CI ta' 90%) ta' 8.75 ms (4.08, 13.42) kienet osservata 10 sigħat wara l-inġestjoni tat-tielet doża ta' lapatinib 2000 mg.
English: b. P-value from Cox regression model, stratifying for site of disease and prior anti-adjuvant therapy at screening.
Maltese: b. Valur-P minn mudell ta' rigressjoni Cox, stratifikat għas-sit tal-marda u t-terapija aġġuvanti qabel l-iskrining.
English: The maximum oral dose of lapatinib that has been administered in clinical studies is 1800 mg once daily.
Maltese: Id-doża orali massima ta' lapatinib li kienet amministrata fi studji kliniċi hija ta' 1800 mg darba kuljum.
English: In the phase III clinical study of Tyverb in combination with letrozole, of the total number of hormone receptor positive metastatic breast cancer patients (Intent to treat population N= 642), 44 % were ≥ 65 years of age.
Maltese: III ta' Tyverb flimkien ma' letrozole, tan-numru totali ta' pazjenti b'kanċer metastatiku tas-sider pożittivi għar-riċettur ta' l-ormon (Popolazzjoni b'intenzjoni li tiġi kkurata N = 642), 44 % kellhom ≥ 65 sena.
English: Tyverb-induced diarrhoea is usually low-grade, with severe diarrhoea of NCI CTCAE grades 3 and 4 occurring in <10% and <1% of patients, respectively.
Maltese: Dijarea kkawżata minn Tyverb normalment hija ta' grad baxx, b'dijarea severa ta' NCI CTCAE grad 3 u 4 isseħħ f'< 10 % u < 1 % tal-pazjenti, rispettivament.
English: Bottles 3 years
Maltese: Fliexken 3 snin
English: Concomitant treatment with inducers of CYP3A4 should be avoided due to risk of decreased exposure to lapatinib (see section 4.5).
Maltese: Kura konkomitanti b'indutturi ta' CYP3A4 għandha tiġi evitata minħabba riskju ta' tnaqqis flesponiment għal lapatinib (ara sezzjoni 4.5).
English: However, when lapatinib was administered in combination with trastuzumab in the metastatic setting, the incidence of cardiac events including LVEF decreases was higher (7%) versus the lapatinib alone arm (2%) in the pivotal trial.
Maltese: Madankollu, meta lapatinib ingħata flimkien ma' trastuzumab f'sitwazzjoni metastatika, linċidenza ta' avvenimenti tal-qalb inkluż tnaqqis fl-LVEF kienet ogħla (7 %) meta mqabbla mal-grupp b'lapatinib waħdu (2 %) fil-prova pivitali.
English: 70 film-coated tablets 84 film-coated tablets 105 film-coated tablets 140 film-coated tablets
Maltese: 70 pillola miksija b'rita 84 pillola miksija b'rita 104 pillola miksija b'rita 140 pillola miksija b'rita
English: Number (%) with event Kaplan-Meier estimate, months a
Maltese: Numru (%) li kellhom lavveniment Stima
English: Lapatinib has also been shown in vitro to inhibit these efflux transporters, as well as the hepatic uptake transporter OATP 1B1, at clinically relevant concentrations (IC50 values were equal to 2.3 µg/ml).
Maltese: Lapatinib in vitro intwera wkoll li jimpedixxi dawn it-trasportaturi ta' l-effluss, kif ukoll ittrasportatur OATP 1B1 ta' l-assorbiment epatiku, f'konċentrazzjonijiet klinikament rilevanti (valuri ta' IC50 kienu ta' 2.3 µg/ml).
English: Patients were randomised to either Tyverb 1250 mg once daily (continuously) plus capecitabine (2000 mg/m2/day on days 1-14 every 21 days), or trastuzumab (loading dose of 8mg/kg followed by 6mg/kg q3 weekly infusions) plus capecitabine (2500mg/m2/day, days 1-14, every 21 days).
Maltese: Il-pazjenti ntagħżlu b'mod każwali biex jew jingħataw Tyverb 1250 mg darba kuljum (kontinwament) u capecitabine (2000 mg/m2/ġurnata filġranet 1-14 kull 21 ġurnata), jew inkella trastuzumab (doża akbar ta' 8mg/kg fil-bidu segwita minn infużjonijiet ta' 6 mg/kg darba kull 3 ġimgħat) u capecitabine (2500mg/m2/ġurnata, ġranet 1-14, kull
English: The clinical relevance of this effect has not been evaluated.
Maltese: Ir-rilevanza klinika ta' dan leffett ma ġietx evalwata.
English: • in combination with trastuzumab for patients with hormone receptor-negative metastatic disease that has progressed on prior trastuzumab therapy(ies) in combination with chemotherapy (see section 5.1).
Maltese: • flimkien ma' trastuzumab għal pazjenti b'marda metastatika negattiva għar-riċetturi tal-ormoni li tkun avvanzat wara terapija/i preċedenti bi trastuzumab flimkien ma' kimoterapija (ara Sezzjoni 5.1).
English: In studies across the clinical development programme for lapatinib, cardiac events including LVEF decreases were reported in approximately 1% of patients.
Maltese: Fi studji mifruxa mal-programm ta' żvilupp kliniku ta' lapatinib, avvenimenti tal-qalb inkluż tnaqqis fl-LVEF kienu rrappurtati f'madwar 1 % tal-pazjenti.
English: Subgroup analysis results based on predefined stratification factor (hormone receptor status) is also shown in Table 5.
Maltese: Ir-riżultati ta' analiżi tas-sottogruppi abbażi ta' fattur ta' stratifikazzjoni predefinit (status tar-riċettur tal-ormoni) huma murija wkoll f'Tabella 5.
English: Component of a multipack, cannot to be sold separately.
Maltese: Jagħmel parti minn pakkett multiplu, ma jistax jinbiegħ separatament.
English: Table 5 Summary of PFS and OS in studies with hormone receptor negative
Maltese: Sommarju tal-PFS u tal-OS fi studji b'riċettur tal-ormoni negattiv
English: • St John's Wort - a herb extract used to treat depression
Maltese: • St John's Wort - estratt mill-ħxejjex użat għall-kura tad-depressjoni
English: Concomitant treatment with inhibitors or inducers of CYP3A4
Maltese: Kura konkomitanti b'inibituri jew indutturi ta' CYP3A4
English: In healthy volunteers receiving ketoconazole, a strong CYP3A4 inhibitor, at 200 mg twice daily for 7 days, systemic exposure to lapatinib (100 mg daily) was increased approximately 3.6-fold, and half-life increased 1.7-fold.
Maltese: F'voluntiera b'saħħithom li kienu qed jirċievu ketoconazole, impeditur qawwi ta' CYP3A4, f'doża ta' 200 mg darbtejn kuljum għal 7 ijiem, esponiment sistemiku għal lapatinib (100 mg kuljum) żdied bejn wieħed u ieħor għal 3.6 darbiet, u l-half-life żdiedet għal 1.7 drabi.
English: There is a positive relationship between lapatinib plasma concentrations and ΔΔQTcF.
Maltese: Teżisti relazzjoni pożittiva bejn il-konċentrazzjonijiet ta' lapatinib fil-plażma u ΔΔQTcF.
English: Tyverb (1250 mg/day) + capecitabine (2000 mg/m2/day, days 1-14 q21 days)
Maltese: Tyverb (1250 mg/ġurnata)+ capecitabine (2000 mg/m2/ġurnata, ġranet 1-14 kull 21 ġurnata)
English: • quinidine, digoxin - medicines used to treat certain heart problems
Maltese: • quinidine, digoxin - mediċini li jintużaw biex jikkuraw ċerti problemi fil-qalb
English: The independent assessment of the data also demonstrated that Tyverb when given in combination with capecitabine significantly increased time to progression (Hazard Ratio 0.57 [95 % CI 0.43, 0.77] p=0.0001) compared to capecitabine alone.
Maltese: Assessjar independenti tad-dejta wera wkoll li Tyverb meta ngħata flimkien ma' capecitabine, żied b'mod sinifikanti iż-żmien sa l-avvanz (Proporzjon ta' periklu 0.57 [95 % CI 0.43, 0.77] p=0.0001) meta mqabbel ma' capecitabine waħdu.
English: Lapatinib was not clastogenic or mutagenic in a battery of assays including the Chinese hamster chromosome aberration assay, the Ames assay, human lymphocyte chromosome aberration assay and an in vivo rat bone marrow chromosome aberration assay.
Maltese: Lapatinib ma kienx klastoġeniku jew mutaġeniku f'għadd kbir ta' analiżi inkluż l-analiżi ta' l-aberrazzjoni tal-kromosoma tal-ħamster Ċiniż, l-analiżi Ames, l-analiżi ta' l-aberrazzjoni tal-kromosoma limfoċita umana u analiżi in vitro ta' l-aberrazzjoni tal-kromosoma tal-mudullun ta' l-għadam tal-far.
English: • headache
Maltese: • fwawar
English: Effects of lapatinib on other medicinal products
Maltese: Effetti ta' lapatinib fuq prodotti mediċinali oħra
English: Lapatinib has in terms of objective responses demonstrated modest activity in the treatment of established CNS metastases.
Maltese: F'termini ta' risponsi oġġettivi, Lapatinib wera attività modesta fil-kura ta' metastażi tas-CNS stabbilita.
English: • skin rash (including itchy, bumpy rash)
Maltese: • raxx fil-ġilda (li jinkludi ħakk, raxx imqabbeż)
English: Tyverb should be discontinued in patients with symptoms associated with decreased left ventricular ejection fraction (LVEF) that are National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade 3 or greater or if their LVEF drops below the institutions lower limit of normal (see section 4.4).
Maltese: Tyverb m'għandux jibqa' jingħata lill-pazjenti b'sintomi assoċjati ma' tnaqqis fil-porzjon imbuttat 'il barra mill-ventrikulu tan-naħa tax-xellug (LVEF) li huma Kriteriji ta' Terminoloġija Komuni għal Reazzjonijiet Avversi ta' l-Istitut Nazzjonali tal-Kanċer (NCI CTCAE) ta' grad 3 jew akbar jew jekk lLVEF tagħhom jonqos aktar mill-limitu l-aktar baxx tan-normal ta' l-istituzzjoni (ara sezzjoni 4.4).
English: In patients who took up to 5000 mg of lapatinib, symptoms observed include known lapatinib associated events (see section 4.8) and in some cases sore scalp and/or mucosal inflammation.
Maltese: Is-sintomi osservati f'pazjenti li ħadu sa 5000 mg ta' lapatinib, is-sintomi osservati jinkludu eventi assoċjati u magħrufa għal lapatinib (ara sezzjoni 4.8) u f'xi każi uġigħ fil-qorriegħa u/jew infjammazzjoni mukosali.
English: Lapatinib is predominantly metabolised by CYP3A (see section 5.2).
Maltese: Lapatinib huwa l-biċċa l-kbira mmetabolizzat permezz ta' CYP3A (ara sezzjoni 5.2).
English: Table 3 Analyses of investigator-assessed progression-free survival and overall survival
Maltese: Tabella 3 Analiżi tas-sopravivenza ħielsa mill-progressjoni u s-sopravivenza globali stmati mill-investigatur
English: (95% CI), p-value b
Maltese: Proporzjon ta' periklu (95% CI) valur-p b
English: The safety and efficacy of Tyverb in children below the age of 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Tyverb fi tfal b'età inqas minn 18-il sena għadhom ma ġewx determinati s'issa.
English: Symptomatic LVEF decreases were observed in approximately 0.3% of patients who received lapatinib monotherapy or in combination with other anti-cancer medicinal products.
Maltese: Tnaqqis fl-LVEF fejn intwerew sintomi kien osservat f'bejn wieħed u ieħor 0.3 % tal-pazjenti li rċievew lapatinib waħdu jew flimkien ma' prodotti mediċinali oħra kontra l-kanċer.
English: 140 film-coated tablets Multipack: 140 (2 packs of 70) film-coated tablets.
Maltese: Pakketti multipli fihom 140 (żewġ pakketi ta' 70) pillola miksija b'rita.
English: Tyverb dosing should be interrupted in patients with diarrhoea which is NCI CTCAE grade 3 or grade 1 or 2 with complicating features (moderate to severe abdominal cramping, nausea or vomiting greater than or equal to NCI CTCAE grade 2, decreased performance status, fever, sepsis, neutropenia, frank bleeding or dehydration) (see sections 4.4 and 4.8).
Maltese: Id-dożaġġ ta' Tyverb għandu jitwaqqaf f'pazjenti b'dijarea li hija ta' NCI CTCAE grad 3 jew grad 1 jew 2 b'karatteristiċi li jikkumplikaw (brim addominali moderat sa sever, dardir jew rimettar aktar minn jew ugwali għal NCI CTCAE grad 2, tnaqqis fl-istat ta' eżekuzzjoni, deni, sepsi, newtropenija, demm frisk fl-ippurgar jew deidratazzjoni) (ara sezzjonijiet 4.4 u 4.8).
English: Co-administration of Tyverb with medicinal products with narrow therapeutic windows that are substrates of CYP2C8 (e.g. repaglinide) should be avoided (see sections 4.4 and 5.2).
Maltese: L-amministrazzjoni ta' Tyverb flimkien ma' prodotti medicinali b'indiċi terapewtiċi dojoq li huma sustrati ta' CYP2C8 (e.ż. repaglinide) għandha tiġi evitata (ara sezzjonijiet 4.4 u 5.2).
English: Diarrhoea, including severe diarrhoea, has been reported with Tyverb treatment (see section 4.8).
Maltese: Dijarea, inkluż dijarea serja kienet irrappurtata f'kura b'Tyverb (ara sezzjoni 4.8).
English: There are limited data on the use of Tyverb / capecitabine and Tyverb / trastuzumab in patients aged ≥ 65 years.
Maltese: Hemm dejta limitata dwar l-użu ta' Tyverb / capecitabine u Tyverb / trastuzumab f'pazjenti li għandom ≥ 65 sena.
English: A concentration dependent increase in QTcF (maximum mean ΔΔQTcF 8.75 ms; 90% CI 4.08, 13.42) was observed in a dedicated QT study in patients with advanced solid tumours (see section 4.4).
Maltese: Fi studju dedikat dwar QT f'pazjenti b'tumuri solidi avanzati kienet osservata żjieda dipendenti millkonċentrazzjoni fi QTcF (medja massima ta' ΔΔQTcF 8.75 ms; CI ta' 90% 4.08, 13.42) (ara sezzjoni 4.4).
English: Administration of lapatinib in patients with hepatic impairment should be undertaken with caution (see sections 4.2 and 4.4).
Maltese: L-amministrazzjoni ta' lapatinib f'pazjenti b'indeboliment epatiku għandha ssir b'attenzjoni (ara sezzjonijiet 4.2 u 4.4).
English: There were no teratogenic effects; however, minor anomalies (left-sided umbilical artery, cervical rib and precocious ossification) occurred in rats at ≥60 mg/kg/day (4 times the expected human clinical exposure).
Maltese: Ma kienx hemm effetti teratoġeniċi; madankollu seħħew anomaliji żgħar (arterja taż-żokra fuq in-naħa tax-xellug, kustilja ċervikali u ossifikazzjoni prekoċi) fil-firien f'doża ta' ≥ 60 mg/kg/kuljum (4 darbiet aktar mill-esponiment kliniku uman mistenni).
English: Interstitial lung disease / pneumonitis
Maltese: Marda tal-interstizju tal-pulmun / pulmonite
English: • pulmonary arterial hypertension (increased blood pressure in the arteries (blood vessels) of the lungs)
Maltese: • pressjoni għolja arterjali pulmonary (żieda fil-pressjoni tad-demm fl-arterji (kanali tad-demm) tal-pulmun)
English: Pre-planned OS analysis (conducted at the time of the final PFS analysis, 03 June 2008) Median follow-up (yrs)
Maltese: Analiżi OS finali (analiżi post-hoc), 07 t'Awwissu 2013)
English: The most common adverse reactions (>25%) during therapy with lapatinib were gastrointestinal events (such as diarrhoea, nausea, and vomiting) and rash.
Maltese: L-aktar reazzjonijiet avversi komuni (> 25 %) waqt kura b'lapatinib kienu avvenimenti gastrointestinali (bħal dijarea, dardir, u rimettar) u raxx.