FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: No, kad se lapatinib primjenjivao u kombinaciji s trastuzumabom u metastatskom okruženju, incidencija kardioloških događaja uključujući smanjenje LVEF bila je viša (7%) u odnosu na skupinu koja je primala samo lapatinib (2%) u pivotalnom ispitivanju.
English: Co-administration of lapatinib with intravenous paclitaxel increased the exposure of paclitaxel by 23%, due to lapatinib inhibition of CYP2C8 and/or Pgp.
Croatian: Istodobna primjena lapatiniba i intravenskog paklitaksela povećava izloženost paklitakselu za 23% zbog inhibicije CYP2C8 i/ili Pgp-a lapatinibom.
English: This previous treatment for metastatic breast cancer must have included trastuzumab.
Croatian: To je prethodno liječenje metastatskog raka dojke moralo uključivati trastuzumab.
English: Prescribing physicians are advised to perform a skin examination prior to treatment and regularly during treatment.
Croatian: Liječnicima propisivačima se preporučuje da izvrše pregled kože bolesnika prije početka liječenja te ih redovito prate tijekom liječenja.
English: Tyverb is supplied in either blisters packs or bottles:
Croatian: Tyverb je dostupan u blisterima ili u bocama:
English: Lapatinib effect on CNS metastasis
Croatian: Učinak lapatiniba na metastaze u CNS-u
English: Decreased left ventricular ejection fraction (see section 4.2 - dose reduction - cardiac events and section 4.4).
Croatian: Smanjenje ejekcijske frakcije lijeve klijetke (vidjeti dio 4.2 - smanjenje doze - srčani događaji i dio 4.4).
English: Lapatinib was studied in pregnant rats and rabbits given oral doses of 30, 60, and 120 mg/kg/day.
Croatian: Lapatinib je ispitivan na trudnim ženkama štakora i kunića kojima su dane oralne doze od 30, 60 i 120 mg/kg/dan.
English: • tiredness, feeling weak
Croatian: • umor, osjećaj slabosti
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).
Croatian: Lapatinib nije značajno inhibirao sljedeće enzime u mikrosomima ljudske jetre: CYP1A2, CYP2C9, CYP2C19 i CYP2D6 ili UGT enzime (in vitro IC50 vrijednosti bile su veće od ili jednake 6,9 μg/ml).
English: However, a few cases of acute renal failure have been reported secondary to severe dehydration due to diarrhoea.
Croatian: Ipak, prijavljeno je nekoliko slučajeva akutnog zatajenja bubrega nakon teške dehidracije uslijed proljeva.
English: Daily dosing of 1250 mg produces steady state geometric mean (coefficient of variation) Cmax values of 2.43 (76%) µg/ml and AUC values of 36.2 (79%) µg*hr/ml.
Croatian: Dnevno doziranje 1250 mg daje u stanju dinamičke ravnoteže geometrijske srednje vrijednosti (koeficijent varijacije) Cmax od 2,43 (76%) μg/ml i AUC vrijednosti od 36,2 (79%) μg*hr/ml.
English: The growth inhibitory effects of lapatinib were evaluated in trastuzumab-conditioned cell lines.
Croatian: Inhibitorni učinci lapatiniba na rast procjenjivani su na staničnim linijama kondicioniranim trastuzumabom.
English: - The other ingredients are: microcrystalline cellulose, povidone (K30), sodium starch glycolate (Type A), magnesium stearate, hypromellose, titanium dioxide (E171), macrogol (400), polysorbate 80, iron oxide yellow (E172), and iron oxide red (E172).
Croatian: - Pomoćne tvari su: mikrokristalična celuloza, povidon (K30), natrijev škroboglikolat (vrsta A), magnezijev stearat, hipromeloza, titanijev dioksid (E171), makrogol (400), polisorbat 80, žuti željezov oksid (E172), i crveni željezov oksid (E172).
English: - The active substance in Tyverb is lapatinib.
Croatian: - Djelatna tvar u lijeku Tyverb je lapatinib.
English: Lapatinib undergoes extensive metabolism, primarily by CYP3A4 and CYP3A5, with minor contributions from CYP2C19 and CYP2C8 to a variety of oxidated metabolites, none of which account for more than 14% of the dose recovered in the faeces or 10% of lapatinib concentration in plasma.
Croatian: Lapatinib se opsežno metabolizira, prvenstveno pomoću CYP3A4 i CYP3A5, s manjim doprinosom CYP2C19 i CYP2C8, do niza oksidiranih metabolita od kojih niti jedan ne čini više od 14% doze koja se nađe u stolici ili 10% koncentracije lapatiniba u plazmi.
English: (95% CI), p-value b
Croatian: (95% CI), p vrijednost b
English: Immune system disorders Rare
Croatian: Poremećaji imunološkog sustava Rijetko
English: Bottles Tyverb is also available in plastic bottles containing 70, 84, 105 or 140 tablets.
Croatian: Boce Tyverb je dostupan i u plastičnim bocama koje sadrže 70, 84, 105 ili 140 tableta.
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).
Croatian: Sigurnost lapatiniba procjenjivana je u monoterapiji ili u kombinaciji s drugim kemoterapijama za različite vrste karcinoma u više od 20 000 bolesnika, uključujući 198 bolesnika koji su primali lapatinib u kombinaciji s kapecitabinom, 149 bolesnika koji su primali lapatinib u kombinaciji s trastuzumabom i 654 bolesnika koji su primali lapatinib u kombinaciji s letrozolom (vidjeti dio 5.1).
English: • if you have any liver problems
Croatian: • ako imate bilo kakvih problema s jetrom
English: Tyverb is prescribed to be taken in combination with another anti-cancer medicine.
Croatian: Tyverb se propisuje za liječenje u kombinaciji s drugim antitumorskim lijekovima.
English: Systemic exposure to lapatinib is increased when administered with food.
Croatian: Sistemska izloženost lapatinibu povećava se kada se uzima s hranom.
English: • topotecan, paclitaxel, irinotecan, docetaxel - medicines used to treat certain types of cancer
Croatian: • topotekan, paklitaksel, irinotekan, docetaksel - lijekovi koji se primjenjuju u liječenju određenih tipova raka
English: The primary route of excretion for lapatinib and its metabolites is in faeces.
Croatian: Primarni put izlučivanja lapatiniba i njegovih metabolita je stolicom.
English: Recovery of unchanged lapatinib in faeces accounts for a median 27% (range 3 to 67%) of an oral dose.
Croatian: Ponovna pojava nepromijenjenog lapatiniba u stolici odgovara prosječno 27% (raspon 3 do 67%) oralne doze.
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%.
Croatian: U zdravih dobrovoljaca koji su primali karbamazepin, induktor CYP3A4, pri dozi od 100 mg dvaput dnevno tijekom 3 dana i 200 mg dvaput dnevno tijekom 17 dana, sistemska izloženost lapatinibu bila je smanjena za oko 72%.
English: • rash, dry skin, itching
Croatian: • osip, suha koža, svrbež
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).
Croatian: Lapatinib, 4-anilinokinazolin je inhibitor intracelularnih tirozin kinaznih domena i EFGR (ErbB1) i HER2 (ErbB2) receptora (utvrđene Ki app vrijednosti 3nM i 13nM, po istom redoslijedu) s polaganom stopom otpuštanja s ovih receptora (poluvijek dulji ili jednak 300 minuta).
English: Most cases of diarrhoea were grade 1 or 2 and did not result in discontinuation of treatment with lapatinib.
Croatian: Većina slučajeva proljeva bila je 1. ili 2. stupnja te nije za posljedicu imala prekid liječenja lapatinibom.
English: Observed adverse reactions included dyspnoea, cardiac failure and palpitations.
Croatian: Primijećene nuspojave uključivale su dispneju, zatajenje srca i palpitacije.
English: Food effects on lapatinib exposure
Croatian: Učinci hrane na izloženost lapatinibu
English: • rosuvastatin - a medicine used to treat high cholesterol
Croatian: • rosuvastatin - lijek koji se primjenjuje u liječenju visokog kolesterola
English: Randomisation was stratified by prior trastuzumab treatment and number of prior treatments for metastatic disease.
Croatian: Randomizacija je stratificirana prema prethodnom liječenju trastuzumabom i broju prethodnih liječenja metastatske bolesti.
English: It cannot be excluded that lapatinib will affect the pharmacokinetics of substrates of BCRP (e.g. topotecan) and OATP1B1 (e.g. rosuvastatin) (see section 5.2).
Croatian: Ne može se isključiti utjecaj lapatiniba na farmakokinetiku supstrata BCRP (npr. topotekan) i OATP1B1 (npr. rosuvastatin) (vidjeti dio 5.2).
English: The bioavailability and thereby the plasma concentrations of lapatinib are increased by food, in relation to the content and timing of the meal.
Croatian: Bioraspoloživost, stoga i koncentracije lapatiniba u plazmi, povećavaju se prilikom jela, ovisno o sastavu i vremenu obroka.
English: a. Estimate of the treatment hazard ratio, where <1 indicates a lower risk with letrozole 2.5 mg + lapatinib 1500 mg compared with letrozole 2.5 mg + placebo.
Croatian: Procjena omjera hazarda liječenja, gdje < 1 ukazuje na manji rizik s letrozol 2,5 mg + lapatinib 1500 mg u usporedbi s letrozol 2,5 mg + placebo.
English: Furthermore, depending on type of food the bioavailability is approximately 2-3 times higher when lapatinib is taken 1 hour after food compared with 1 hour before the first meal of the day (see sections 4.2 and 5.2).
Croatian: Nadalje, ovisno o vrsti hrane, bioraspoloživost je približno 2-3 puta veća kada se lapatinib uzme 1 sat nakon jela u usporedbi s uzimanjem 1 sat prije prvog obroka u danu (vidjeti dijelove 4.2 i
English: Rash was generally low grade and did not result in discontinuation of treatment with lapatinib.
Croatian: Osip je općenito bio niskog stupnja težine i nije rezultirao prekidom liječenja lapatinibom.
English: The recommended dose of capecitabine is 2000 mg/m2/day taken in 2 doses 12 hours apart on days 1-14 in a 21 day cycle (see section 5.1).
Croatian: Preporučena doza kapecitabina je 2000 mg/m2/dan, podijeljeno u 2 doze u razmaku od 12 sati, od 1. do 14. dana u 21-dnevnom ciklusu (vidjeti dio 5.1).
English: Table 3 Analyses of investigator-assessed progression-free survival and overall survival
Croatian: Tablica 3 Analiza prema procijeni ispitivača o preživljenju bez progresije bolesti i ukupnom preživljenju
English: Grapefruit juice may inhibit CYP3A4 in the gut wall and increase the bioavailability of lapatinib and should therefore be avoided during treatment with Tyverb.
Croatian: Sok od grejpa može inhibirati CYP3A4 u stijenki crijeva i povisiti bioraspoloživost lapatiniba te ga je stoga potrebno izbjegavati tijekom liječenja lijekom Tyverb.
English: Tyverb is prescribed in combination with an aromatase inhibitor, for patients with hormone sensitive metastatic breast cancer (breast cancer that is more likely to grow in the presence of hormones), who are not currently intended for chemotherapy.
Croatian: Tyverb se propisuje u kombinaciji s inhibitorom aromataze, za bolesnike s metastatskim rakom dojke osjetljivim na hormone (rak dojke koji za koji je više vjerojatno da će rasti u prisustvu hormona), a za koje trenutno nije namijenjena kemoterapija.
English: In the Tyverb plus capecitabine arm 8 patients (3.2%) experienced CNS as site of first progression, compared with 12 patients (4.8%) in the trastuzumab plus capecitabine arm.
Croatian: U skupini Tyverb plus kapecitabin 8 bolesnika (3,2%) je imalo CNS kao mjesto prve progresije u usporedbi s 12 bolesnika (4,8%) u skupini trastuzumab plus kapecitabin.
English: Lapatinib AUC values were approximately 3- and 4-fold higher (Cmax approximately 2.5 and 3-fold higher) when administered with a low fat (5% fat [500 calories]) or with a high fat (50% fat [1,000 calories]) meal, respectively, as compared with administration in the fasted state.
Croatian: AUC vrijednosti lapatiniba bile su oko 3 do 4 puta više (Cmax oko 2,5 i 3 puta više) pri unosu s obrokom s niskim sadržajem masnoća (5% masnoća [500 kalorija]) ili obrokom s visokim sadržajem masnoća (50% masnoća [1000 kalorija], u usporedbi s primjenom u stanju gladovanja.
English: The pharmacokinetics of lapatinib were examined in patients with moderate (n = 8) or severe (n = 4) hepatic impairment (Child-Pugh scores of 7-9, or greater than 9, respectively) and in 8 healthy control patients.
Croatian: Farmakokinetika lapatiniba ispitivana je u ispitanika s umjerenim (n=8) ili teškim (n = 4) oštećenjem funkcije jetre (Child-Pugh zbroj 7-9, odnosno viši od 9) i u 8 zdravih kontrolnih ispitanika.
English: It is especially important to tell your doctor if you are taking, or have recently taken any of the following medicines.
Croatian: Osobito je važno obavijestiti svog liječnika ako uzimate ili ste nedavno uzimali neki od dolje navedenih lijekova.
English: The cumulative frequency in DQA1*02:01 and DRB1*07:01 allele carriers was 10.3% and in non-carriers was 0.5%.
Croatian: Kumulativna učestalost kod nositelja DQA1*02:01 i DRB1*07:01 alela bila je 10,3%, a kod osoba koje nisu nositelji je iznosila 0,5%.
English: Patients who carry the HLA alleles DQA1*02:01 and DRB1*07:01 have increased risk of Tyverb-associated hepatotoxicity.
Croatian: Bolesnici koji nose HLA alele DQA1*02:01 i DRB1*07:01 imaju povišen rizik od hepatotoksičnosti povezane s lijekom Tyverb.
English: Relative to dosing 1 hour before a low fat breakfast, mean AUC values were approximately 2- and 3-fold higher when lapatinib was administered 1 hour after a low fat or high fat meal, respectively.
Croatian: U odnosu na doziranje 1 sat prije doručka s niskim udjelom masnoća, srednje vrijednosti AUC bile su 2 do 3 puta više kada se lapatinib primjenjivao 1 sat nakon obroka s niskim odnosno visokim udjelom masnoća.
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).
Croatian: Nije bilo teratogenih učinaka, međutim, manje anomalije (pupčana arterija na lijevoj strani, vratno rebro i prijevremena osifikacija) pojavile su se kod štakora pri dozi ≥ 60 mg/kg/dan (4 puta više od očekivane kliničke izloženosti kod ljudi).
English: In the clinical study LVEF was monitored at approximately eight week intervals during treatment with Tyverb to ensure it did not decline to below the institutions lower limit of normal.
Croatian: U kliničkom ispitivanju LVEF je praćena tijekom liječenja lapatinibom, u intervalima od približno osam tjedana, kako bi se osiguralo da njena vrijednost ne padne ispod utvrđene donje granice normalnih vrijednosti.
English: Palmar-plantar erythrodysesthesia (PPE) was also common (>25%) when lapatinib was administered in combination with capecitabine.
Croatian: Palmarno-plantarna eritrodizestezija bila je česta (> 25%) i pri primjeni kombinacije lapatiniba i kapecitabina.
English: Oval, biconvex, yellow film-coated tablets, with “GS XJG” debossed on one side.
Croatian: Ovalne, bikonveksne, filmom obložene tablete žute boje, s utisnutom oznakom „GS XJG“ na jednoj strani.
English: Grapefruit juice should be avoided during treatment with Tyverb (see section 4.5).
Croatian: Potrebno je izbjegavati sok od grejpa tijekom liječenja lijekom Tyverb (vidjeti dio 4.5).
English: Lapatinib has been associated with reports of decreases in LVEF (see section 4.8).
Croatian: Lapatinib je povezan s prijavljenim smanjenjem LVEF-a (vidjeti dio 4.8).
English: Women of childbearing potential should be advised to use adequate contraception and avoid becoming pregnant while receiving treatment with Tyverb and for at least 5 days after the last dose.
Croatian: Ženama u reproduktivnoj dobi mora se savjetovati primjena odgovarajuće kontracepcije kako bi izbjegle trudnoću tijekom liječenja lijekom Tyverb i još najmanje 5 dana nakon posljednje doze.
English: • verapamil - a medicine used to treat high blood pressure or heart problems (angina)
Croatian: • verapamil - lijek koji se primjenjuje u liječenju visokog krvnog tlaka ili srčanih poremećaja
English: Tell your doctor as soon as possible if you get any of these symptoms.
Croatian: Obavijestite svog liječnika što je prije moguće ako Vam se pojavi bilo koji od tih simptoma.
English: Dosing of lapatinib one hour after a meal results in approximately 2-3 times higher systemic exposure, compared to dosing one hour before a meal (see sections 4.5 and 5.2).
Croatian: Doziranje lapatiniba jedan sat nakon obroka rezultira približno 2-3 puta većom sistemskom izloženosti u usporedbi s doziranjem jedan sat prije obroka (vidjeti dijelove 4.5 i
English: Tyverb is used to treat certain types of breast cancer (HER2-overexpressing) which have spread beyond the original tumour or to other organs (advanced or metastatic breast cancer).
Croatian: Tyverb se koristi u liječenju određenih vrsta raka dojke (s prekomjerno izraženim HER2) koji se proširio izvan mjesta početnog tumora ili na druge organe (uznapredovali ili metastatski rak dojke).
English: At the start of therapy, the patients bowel pattern and any other symptoms (e.g. fever, cramping pain, nausea, vomiting, dizziness and thirst) should be determined, to allow identification of changes during treatment and to help identify patients at greater risk of diarrhoea.
Croatian: Na početku liječenja potrebno je utvrditi motilitet crijeva bolesnika i bilo koje druge simptome (npr. vrućicu, bol tipa grčeva, mučninu, povraćanje, omaglicu i žeđ) kako bi bilo moguće uočiti bilo kakve promjene tijekom liječenja i lakše identificirati bolesnike s povišenim rizikom od pojave proljeva.
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.
Croatian: U velikom, randomiziranom kliničkom ispitivanju monoterapije lijekom Tyverb (n=1194), kumulativna učestalost teških oštećenja jetre (ALT > 5 puta iznad gornje granice normale, 3. stupanj prema NCI CTCAE) po isteku 1. godine liječenja bila je ukupno 2,8%.
English: • eat low-fat, high protein foods instead of fatty or spicy foods
Croatian: • jedite hranu sa smanjenim udjelom masnoća i bogatu bjelančevinama umjesto masne i začinjene hrane
English: Ventricular arrhythmias/Torsades de Pointes, electrocardiogram QT prolonged**
Croatian: Ventrikulske aritmije/Torsade de Pointes, produljenje QT intervala u elektrokardiogramu**.
English: Other uncommon side effects include:
Croatian: Ostale manje česte nuspojave uključuju:
English: Lapatinib retained significant activity against HER2-amplified breast cancer cell lines selected for long-term growth in trastuzumab-containing medium in vitro and was synergistic in combination with trastuzumab in these cell lines.
Croatian: Lapatinib je in vitro zadržao značajnu aktivnost prema HER2 amplificiranim staničnim linijama raka dojke selektiranim za dugoročan rast u mediju koji sadrži trastuzumab te je u tim staničnim linijama pokazao sinergistički učinak u kombinaciji s trastuzumabom.
English: b. Pike estimate of the treatment hazard ratio, <1 indicates a lower risk for Tyverb plus capecitabine compared with Trastuzumab plus capecitabine.
Croatian: b. Najviša vrijednost procjene omjera hazarda za liječenje, < 1 znači niži rizik za Tyverb plus kapecitabin u usporedbi s trastuzumab plus kapecitabin.
English: Tell your doctor immediately if you get any of these symptoms.
Croatian: Odmah obavijestite svog liječnika ako primijetite bilo koji od ovih simptoma.
English: Lapatinib is predominantly metabolised by CYP3A (see section 5.2).
Croatian: Lapatinib se većinom metabolizira pomoću CYP3A (vidjeti dio 5.2).
English: • an effect on how your heart works
Croatian: • utjecaj na rad srca
English: • in combination with an aromatase inhibitor for postmenopausal women with hormone receptor positive metastatic disease, not currently intended for chemotherapy.
Croatian: • u kombinaciji s inhibitorom aromataze za žene u postmenopauzi s metastatskom bolesti uz pozitivne hormonske receptore, a koje trenutno nisu kandidati za kemoterapiju.
English: Take special care with Tyverb
Croatian: Budite posebno oprezni s lijekom Tyverb
English: In rats, the incidence of benign haemangioma of the mesenteric lymph nodes was higher in some groups than in concurrent controls.
Croatian: Incidencija benignih hemangioma mezenteričnih limfnih čvorova u štakora, u nekim skupinama bila je veća nego u usporednim kontrolama.
English: Severe cases of diarrhoea may require administration of oral or intravenous electrolytes and fluids, use of antibiotics such as fluoroquinolones (especially if diarrhoea is persistent beyond 24 hours, there is fever, or grade 3 or 4 neutropenia) and interruption or discontinuation of Tyverb therapy (see section 4.2 - dose delay and dose reduction -diarrhoea).
Croatian: Teški slučajevi proljeva mogu zahtijevati primjenu elektrolita i tekućine peroralnim ili intravenskim putem, primjenu antibiotika kao što su fluorokinoloni (posebno ako proljev potraje duže od 24 sata, ako je praćen vrućicom ili neutropenijom 3. ili 4. stupnja), te pauzu ili prekid liječenja lijekom Tyverb (vidjeti dio 4.2 - odgađanje i smanjenje doze - proljev).
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).
Croatian: O koncentraciji ovisno povećanje QTcF (maksimalna srednja vrijednost ΔΔQTcF je 8,75 ms; 90% CI 4,08; 13,42) zabilježeno je u posebnom ispitivanju QT intervala u bolesnika s uznapredovalim solidnim tumorima (vidjeti dio 4.4).
English: OUTER CARTON (28-DAY, MULTIPACK)
Croatian: VANJSKA KUTIJA (28 DANA, VIŠESTRUKO PAKIRANJE)
English: Lapatinib produced a maximum mean concentration of 3920 (3450-4460) ng/ml (geometric mean/95% CI), exceeding the geometric mean Cmax.ss and 95% CI values observed following the approved dosing regimens.
Croatian: Maksimalna prosječna koncentracija lapatiniba od 3920 (3450-4460) ng/ml (geometrijska srednja vrijednost/95% CI) premašuje geometrijsku srednju vrijednost Cmax.ss i vrijednosti 95% CI koje su opažene tijekom odobrenih režima doziranja.
English: • wash with a soap-free cleanser
Croatian: • za kupanje koristite sredstvo za čišćenje bez sapuna
English: There was also an increase in renal infarcts and papillary necrosis in female rats at exposures 7 and 10-fold compared to humans given 1250 mg of lapatinib once daily.
Croatian: Također je zabilježen i porast incidencije infarkta bubrega i papilarne nekroze u ženki štakora pri izloženosti 7 i 10 puta većoj nego u ljudi pri primjeni 1250 mg lapatiniba jednom dnevno.
English: Caution should be taken if Tyverb is administered to patients with conditions that could result in prolongation of QTc (including hypokalemia, hypomagnesemia, and congenital long QT syndrome), co-administration of other medicinal product known to cause QT prolongation, or conditions that increase the exposure of lapatinib, such as co-administration of strong CYP3A4 inhibitors.
Croatian: Potreban je oprez ukoliko se Tyverb primjenjuje u bolesnika sa stanjima koja mogu rezultirati produljenjem QTc intervala (uključujući hipokalijemiju, hipomagnezijemiju, i kongenitalni sindrom produljenog QT intervala), kod istodobne primjene drugih lijekova za koje je poznato da produljuju QT interval, ili u stanjima koja povećavaju izloženost lapatinibu, kao što je istodobna primjena snažnih inhibitora CYP3A4.
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).
Croatian: • u kombinaciji s trastuzumabom za bolesnike s metastatskom bolesti uz negativne hormonske receptore koja je progredirala na prethodnoj terapiji (terapijama) trastuzumabom u kombinaciji s kemoterapijom (vidjeti dio 5.1).