FrancophonIA/ELRC3.0 huggingface dataset:
English: Tyverb is prescribed in combination with capecitabine, for patients who have had treatment for advanced or metastatic breast cancer before.
Croatian: Tyverb se propisuje u kombinaciji s kapecitabinom, za bolesnike koji su prethodno liječeni zbog uznapredovalog ili metastatskog raka dojke.
English: Table 2 Overall survival data from Study EGF100151 (Tyverb / capecitabine)
Croatian: Tablica 2 Podaci o ukupnoj stopi preživljenja iz studije EGF100151 (Tyverb/kapecitabin)
English: †, dyspnoea
Croatian: †, dispneja
English: Lapatinib inhibits the transport proteins BCRP and OATP1B1 in vitro.
Croatian: Lapatinib inhibira prijenosne proteine BCRP i OATP1B1 in vitro.
English: • nefazodone - a medicine used to treat depression
Croatian: • nefazodon - lijek koji se primjenjuje u liječenju depresije
English: Tell your doctor if any of these side effects get severe or troublesome.
Croatian: Obavijestite svog liječnika ako ovi simptomi poprime teži oblik ili počnu stvarati probleme.
English: Table 6 Progression free survival data from Study EGF30008 (Tyverb / letrozole)
Croatian: Tablica 6 Podaci o preživljenju bez progresije bolesti iz ispitivanja EGF30008 (Tyverb/letrozol)
English: Tyverb treatment should only be initiated by a physician experienced in the administration of anti-cancer medicinal products.
Croatian: Liječenje lijekom Tyverb smije započeti isključivo liječnik s iskustvom u primjeni antineoplastičnih lijekova.
English: Tyverb should be discontinued in patients who experience pulmonary symptoms which are NCI CTCAE grade 3 or greater (see section 4.4).
Croatian: Primjenu lijeka Tyverb potrebno je prekinuti u bolesnika koji imaju plućne simptome, a koji su prema NCI CTCAE kriterijima 3. ili višeg stupnja (vidjeti dio 4.4).
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).
Croatian: • u kombinaciji s kapecitabinom za bolesnike s uznapredovalom ili metastatskom bolesti koja je progredirala nakon prethodnog liječenja koje je moralo uključivati antracikline i taksane te nakon liječenja metastatske bolesti trastuzumabom (vidjeti dio 5.1).
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*.
Croatian: Proljev, koji može dovesti do dehidracije (vidjeti dio 4.2 - odgađanje doze i smanjenje doze - druge toksičnosti i dio 4.4), mučnina, povraćanje, dispepsija*, stomatitis*, konstipacija*, bol u abdomenu*.
English: The primary endpoint was time to progression (TTP).
Croatian: Primarni ishod ispitivanja bilo je vrijeme do progresije bolesti.
English: Each pack of Tyverb contains 70 film-coated tablets in foil blisters (polyamide / aluminium / polyvinyl chloride / aluminium) of 10 tablets each.
Croatian: Svako pakiranje lijeka Tyverb sadrži 70 filmom obloženih tableta u blisterima od folije (poliamid/ aluminij/ polivinilklorid/ aluminij), po 10 tableta u svakom.
English: In patients with HER2-overexpressing MBC, investigator-determined progression-free survival (PFS) was significantly greater with letrozole plus Tyverb compared with letrozole plus placebo.
Croatian: U bolesnica s HER2-prekomjernom ekspresijom i metastatskim karcinomom dojke preživljenje bez progresije bolesti (PFS) određeno od strane ispitivača bilo je značajno veće za letrozol plus Tyverb nasuprot letrozol plus palcebo.
English: Tell your doctor if you are taking, or have recently taken, any of these.
Croatian: Obavijestite svog liječnika ako uzimate ili ste nedavno uzimali neki od ovih lijekova.
English: • ritonavir, saquinavir - medicines used to treat HIV
Croatian: • ritonavir, sakvinavir - lijekovi koji se primjenjuju u liječenju infekcije virusom HIV
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.
Croatian: Proljev se pojavio u oko 65% bolesnika koji su primali lapatinib u kombinaciji s kapecitabinom, u 64% bolesnika koji su primali lapatinib u kombinaciji s letrozolom i 62% bolesnika koji su primali lapatinib u kombinaciji s trastuzumabom.
English: Concomitant treatment with strong inhibitors of CYP3A4 should be avoided due to risk of increased exposure to lapatinib (see section 4.5).
Croatian: Potrebno je izbjegavati istodobno liječenje snažnim inhibitorima CYP3A4 zbog rizika od povećane izloženosti lapatinibu (vidjeti dio 4.5).
English: 140 film-coated tablets Multipack: 140 (2 packs of 70) film-coated tablets.
Croatian: Višestruko pakiranje: 140 (2 pakiranja od 70) filmom obloženih tableta.
English: There are no adequate data from the use of Tyverb in women of childbearing potential.
Croatian: Nema odgovarajućih podataka o primjeni lijeka Tyverb u žena reproduktivne dobi.
English: • if you have lung disease
Croatian: • ako imate bolest pluća
English: The following adverse reactions have been reported to have a causal association with lapatinib alone or lapatinib in combination with capecitabine, trastuzumab or letrozole.
Croatian: Prijavljene su sljedeće nuspojave kao uzročno povezane s lapatinibom u monoterapiji ili lapatinibom u kombinaciji s kapecitabinom, trastuzumabom ili letrozolom.
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).
Croatian: Primjenu lijeka Tyverb potrebno je prekinuti u bolesnika sa simptomima povezanim sa smanjenom ejekcijskom frakcijom lijeve klijetke (LVEF), 3. ili višeg stupnja prema Zajedničkim terminološkim kriterijima za nuspojave Nacionalnog instituta za tumore (NCI CTCAE), ili ako se vrijednost ejekcijske frakcije lijeve klijetke (LVEF) spusti ispod utvrđene donje granice normalnih vrijednosti (vidjeti dio 4.4).
English: Very common Insomnia*
Croatian: Insomnija*
English: The Phase III study (EGF30008) was randomised, double-blind, and placebo controlled.
Croatian: Ispitivanje faze III (EGF30008) koje je bilo randomizirano, dvostruko slijepo i placebom kontrolirano je uključilo bolesnice koje ranije nisu liječene zbog metastatske bolesti.
English: Multipacks contain 140 (2 packs of 70) film-coated tablets.
Croatian: Višestruka pakiranja, koja sadrže 140 (2 pakiranja po 70) filmom obloženih tableta.
English: • cough, shortness of breath
Croatian: • kašalj, nedostatak zraka
English: Each foil has a perforation down the middle to allow the blisters to be separated into a daily dose of 5 tablets.
Croatian: Svaka folija ima perforaciju po sredini kako bi omogućila odvajanje dijela blistera u dnevnu dozu od 5 tableta.
English: Number of TTP events 121 Median TTP, weeks Hazard Ratio (95% CI) p value
Croatian: Broj TTP događaja Medijan vremena do progresije bolesti, tjedni Omjer hazarda (95% CI) p vrijednost
English: Patients were randomised to letrozole 2.5 mg once daily plus Tyverb 1500 mg once daily or letrozole with placebo.
Croatian: Bolesnice su randomizirane kako bi primale letrozol 2,5 mg jednom dnevno plus Tyverb 1500 mg jednom dnevno ili letrozol plus placebo.
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.
Croatian: Osip se pojavio u oko 28% bolesnika koji su primali lapatinib u kombinaciji s kapecitabinom u 45% bolesnika koji su primali lapatinib u kombinaciji s letrozolom i u 23% bolesnika koji su primali lapatinib u kombinaciji s trastuzumabom.
English: Serious skin reactions have been seen with Tyverb.
Croatian: Ozbiljne kožne reakcije primijećene su pri primjeni lijeka Tyverb.
English: Each foil has a perforation down the middle to allow the blisters to be separated into a daily dose of 6 tablets.
Croatian: Svaka folija ima perforaciju po sredini kako bi omogućila odvajanje dijela blistera u dnevnu dozu od 6 tableta.
English: Tyverb 1500 mg / day + Letrozole 2.5 mg /day N=111
Croatian: Tyverb 1500 mg / dan + Letrozol 2,5 mg /dan N = 111
English: †, cough
Croatian: †, kašalj
English: • repaglinide - a medicine used to treat diabetes
Croatian: • repaglinid - lijek koji se primjenjuje u liječenju šećerne bolesti
English: Systemic exposure to lapatinib is also affected by the timing of administration in relation to food intake.
Croatian: Na sistemsku izloženost lapatinibu utječe vrijeme njegove primjene u odnosu na vrijeme uzimanja obroka.
English: Lapatinib inhibits CYP3A4 in vitro at clinically relevant concentrations.
Croatian: Lapatinib inhibira CYP3A4 in vitro pri klinički značajnim koncentracijama.
English: No dose adjustment is necessary in patients with mild to moderate renal impairment.
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim do umjerenim oštećenjem funkcije bubrega.
English: Left ventricular ejection fraction (LVEF) decreases have been reported in approximately 1% of patients receiving lapatinib and were asymptomatic in more than 70% of cases.
Croatian: Smanjenje ejekcijske frakcije lijeve klijetke (LVEF) prijavljeno je u oko 1% bolesnika pri liječenju lapatinibom, a koji su bili bez simptoma u više od 70% slučajeva.
English: Concomitant treatment with substances that increase gastric pH should be avoided, as lapatinib solubility and absorption may decrease.
Croatian: Potrebno je izbjegavati istodobnu primjenu s tvarima koje povisuju pH vrijednost želuca, s obzirom da može doći do smanjenja topljivosti i apsorpcije lapatiniba.
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).
Croatian: Bolesnici su randomizirani na peroralnu primjenu lapatiniba u dozi od 1000 mg jednom dnevno u kombinaciji s intravenskom udarnom dozom trastuzumaba od 4 mg/kg, nakon čega je slijedila intravenska doza od 2 mg/kg jednom tjedno (N = 148), ili na peroralnu primjenu lapatiniba u dozi od 1500 mg jednom dnevno (N = 148).
English: How to store Tyverb
Croatian: Kako čuvati Tyverb
English: Interstitial lung disease/pneumonitis.
Croatian: Intersticijska bolest pluća/pneumonitis.
English: 70 film-coated tablets 84 film-coated tablets
Croatian: Filmom obložena tableta 70 filmom obloženih tableta 84 filmom obloženih tableta
English: Iron oxide yellow (E172) Iron oxide red (E172)
Croatian: Ovojnica tablete hipromeloza titanijev dioksid (E171) makrogol (400) polisorbat 80 željezov oksid, žuti (E172) željezov oksid, crveni (E172)
English: Tyverb / aromatase inhibitor combination posology
Croatian: Doziranje pri kombinaciji Tyverb/inhibitor aromataze
English: Concomitant treatment with inducers of CYP3A4 should be avoided due to risk of decreased exposure to lapatinib (see section 4.5).
Croatian: Potrebno je izbjegavati istodobno liječenje induktorima CYP3A4 zbog rizika od smanjene izloženosti lapatinibu (vidjeti dio 4.5).
English: Your doctor will run tests to check that your heart is working properly before and during your treatment with Tyverb.
Croatian: Liječnik će provesti pretrage u svrhu provjere rada Vašeg srca prije i tijekom liječenja lijekom Tyverb.
English: Patients were randomised to receive either Tyverb 1250 mg once daily (continuously) plus capecitabine (2000 mg/m2/day on days 1-14 every 21 days), or to receive capecitabine alone
Croatian: Bolesnici su bili randomizirani da primaju ili Tyverb 1250 mg jednom dnevno (kontinuirano) plus kapecitabin (2000 mg/m2/dan od 1. do 14. dana svakih 21 dan), ili da primaju samo kapecitabin
English: Tyverb dosing should be permanently discontinued in patients with diarrhoea which is NCI CTCAE grade 4.
Croatian: Primjenu lijeka Tyverb potrebno je trajno prekinuti u bolesnika s proljevom 4. stupnja po NCI CTCAE.
English: Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
Croatian: Daljnje zbrinjavanje je potrebno ukoliko je klinički indicirano ili ga preporučuje
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.
Croatian: Smanjenje LVEF prijavljeno je u 6,7% bolesnika koji su primali lapatinib u kombinaciji s trastuzumabom, u odnosu na 2,1% bolesnika koji su primali samo lapatinib.
English: Interstitial lung disease / pneumonitis
Croatian: Intersticijska bolest pluća / pneumonitis
English: Lapatinib inhibits the transport protein Pgp in vitro at clinically relevant concentrations.
Croatian: Lapatinib in vitro inhibira transportni protein Pgp u klinički značajnim koncentracijama.
English: Co-administration of Tyverb with known inducers of CYP3A4 (e.g. rifampicin, rifabutin, carbamazepine, phenytoin or Hypericum perforatum [St John's Wort]) should be avoided.
Croatian: Potrebno je izbjegavati istodobnu primjenu lijeka Tyverb s poznatim induktorima CYP3A4 (npr. rifampicin, rifabutin, karbamazepin, fenitoin ili gospina trava).
English: Patients should be monitored for symptoms of pulmonary toxicity (dyspnoea, cough, fever) and treatment discontinued in patients who experience symptoms which are NCI CTCAE grade 3 or greater.
Croatian: Potrebno je pratiti bolesnike kako bi se uočili simptomi plućne toksičnosti (dispneja, kašalj, vrućica) i liječenje prekinuti u bolesnika koji prema Zajedničkim terminološkim kriterijima za nuspojave Nacionalnog instituta za tumore imaju simptome 3. ili višeg stupnja.
English: • phenytoin, carbamazepine - medicines used to treat seizures
Croatian: • fenitoin, karbamazepin - lijekovi koji se primjenjuju u liječenju epileptičkih napadaja
English: If you are prescribed Tyverb in combination with an aromatase inhibitor, the usual dose is 6 Tyverb tablets a day, as a single dose.
Croatian: Ukoliko Vam je propisan Tyverb u kombinaciji s inhibitorom aromataze, uobičajena doza je 6 tableta lijeka Tyverb na dan, u jednoj dozi.
English: Please refer to the full prescribing information of the co-administered aromatase inhibitor for dosing details.
Croatian: Za informacije o doziranju istodobno primijenjenog inhibitora aromataze pogledajte njegove cjelokupne informacije o propisivanju.
English: Serious cutaneous reactions have been reported with Tyverb.
Croatian: Prijavljene su ozbiljne kožne reakcije pri primjeni lijeka Tyverb.
English: Tyverb 250 mg tablets lapatinib
Croatian: Tyverb 250 mg tablete lapatinib
English: • if you have inflammation of the lung
Croatian: • ako imate upalu pluća
English: Tyverb may be reintroduced at a lower dose (reduced from 1000 mg/day to 750 mg/day, from 1250 mg/day to 1000 mg/day or from 1500 mg/day to 1250 mg/day) when diarrhoea resolves to grade 1 or less.
Croatian: Liječenje lijekom Tyverb može se ponovo započeti u manjoj dozi (smanjenoj sa 1000 mg/dan na 750 mg/dan, sa 1250 mg/dan na 1000 mg/dan ili sa 1500 mg/dan na 1250 mg/dan) kad se proljevi ublaže na 1. stupanj ili nestanu.
English: Microcrystalline cellulose Povidone (K30)
Croatian: Jezgra tablete celuloza, mikrokristalična povidon (K30) natrijev škroboglikolat, vrste
English: The recommended dose of Tyverb is 1000 mg (i.e. four tablets) once daily continuously.
Croatian: Preporučena doza lijeka Tyverb je 1000 mg (tj. četiri tablete) jednom dnevno kontinuirano.
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.
Croatian: Simptomatsko smanjenje LVEF primijećeno je u oko 0,3% bolesnika koji su primali monoterapiju lapatinibom ili lapatinib u kombinaciji s drugim antitumorskim lijekovima.
English: The clinical status of the patient and the safety profile of lapatinib should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills.
Croatian: Kada se razmatra bolesnikova sposobnost izvođenja zadataka koji zahtijevaju prosudbene, motoričke i kognitivne vještine, potrebno je imati u vidu klinički status bolesnika i sigurnosni profil lapatiniba.
English: LVEF decreases were reported in 3.1 % of patients who received lapatinib in combination with letrozole as compared to 1.3 % of patients receiving letrozole plus placebo.
Croatian: Smanjenje LVEF prijavljeno je u 3,1% bolesnika koji su primali lapatinib u kombinaciji s letrozolom u usporedbi s 1,3% bolesnika koji su primali letrozol i placebo.
English: Interstitial lung disease and pneumonitis
Croatian: Intersticijska bolest pluća i pneumonitis
English: The recommended dose of Tyverb is 1250 mg (i.e. five tablets) once daily continuously.
Croatian: Preporučena doza lijeka Tyverb je 1250 mg (tj. pet tableta) jednom dnevno kontinuirano.
English: • a skin reaction on the palms of the hands or soles of the feet (including tingling, numbness,
Croatian: • kožnu reakciju na dlanovima ili tabanima (uključujući trnce, utrnulost, bol, otečenost ili crvenilo)
English: Subjects who had not received prior trastuzumab* N
Croatian: Ispitanici koji su prethodno nisu primili trastuzumab* N
English: Table 4 Progression-free survival and overall survival data (Tyverb / trastuzumab)
Croatian: Tablica 4 Podaci o preživljenju bez progresije bolesti i ukupnom preživljenju (Tyverb / trastuzumab)
English: Subgroup analysis results based on predefined stratification factor (hormone receptor status) is also shown in Table 5.
Croatian: Sažetak ishoda djelotvornosti i podataka o ukupnom preživljenju nalazi se u Tablici 4. U Tablici 5 nalaze se rezultati analize podskupina na temelju unaprijed zadanog faktora stratifikacije (status hormonskih receptora).
English: • use fragrance free, hypoallergenic beauty products
Croatian: • koristite hipoalergijske, kozmetičke preparate bez mirisa
English: Lapatinib inhibits CYP2C8 in vitro at clinically relevant concentrations.
Croatian: Lapatinib inhibira CYP2C8 in vitro pri klinički značajnim koncentracijama.
English: Administration of lapatinib in patients with hepatic impairment should be undertaken with caution (see sections 4.2 and 4.4).
Croatian: Potreban je oprez pri primjeni lapatiniba u bolesnika s oštećenjem funkcije jetre (vidjeti dijelove 4.2 i 4.4).
English: Co-administration of Tyverb with orally administered medicinal products with narrow therapeutic windows that are substrates of CYP3A4 (e.g. cisapride, pimozide and quinidine) should be avoided (see sections 4.4 and 5.2).
Croatian: Potrebno je izbjegavati istodobnu primjenu lijeka Tyverb s lijekovima za peroralnu primjenu uske terapijske širine koji su supstrati CYP3A4 (npr. cisaprid, pimozid i kinidin) (vidjeti dijelove 4.4 i 5.2).
English: Caution is warranted if Tyverb is prescribed to patients with moderate or severe hepatic impairment and to patients with severe renal impairment (see sections 4.2 and 5.2).
Croatian: Neophodan je oprez pri primjeni lijeka Tyverb u bolesnika s umjerenim do teškim oštećenjem funkcije jetre i bolesnika s teškim oštećenjem funkcije bubrega (vidjeti dijelove 4.2 i 5.2).
English: If you are prescribed Tyverb in combination with trastuzumab, the usual dose is 4 Tyverb tablets a day, as a single dose.
Croatian: Ukoliko Vam je propisan Tyverb u kombinaciji s trastuzumabom, uobičajena doza je 4 tablete lijeka Tyverb na dan, u jednoj dozi.
English: Concomitant treatment with substances that increase gastric pH should be avoided, as lapatinib solubility and absorption may decrease (see section 4.5).
Croatian: Potrebno je izbjegavati istodobno liječenje tvarima koje povisuju pH želuca, s obzirom da može doći do smanjenja topljivosti i apsorpcije lapatiniba (vidjeti dio 4.5).
English: Tyverb is prescribed in combination with trastuzumab, for patients who have hormone receptornegative metastatic breast cancer and have had other treatment for advanced or metastatic breast cancer before.
Croatian: Tyverb se propisuje u kombinaciji s trastuzumabom, za bolesnike s metastatskim rakom dojke negativnim na hormonske receptore koji su prethodno liječeni drugim lijekovima za uznapredovali ili metastatski rak dojke.
English: If you are prescribed Tyverb in combination with capecitabine, the usual dose is 5 Tyverb tablets a day, as a single dose.
Croatian: Ukoliko Vam je propisan Tyverb u kombinaciji s kapecitabinom, uobičajena doza je 5 tableta lijeka Tyverb na dan, u jednoj dozi.
English: LVEF was evaluated in all patients (using echocardiogram [Echo] or multi gated acquisition scan [MUGA]) prior to initiation of treatment with Tyverb to ensure baseline LVEF was within the institutions normal limits.
Croatian: Ejekcijska frakcija lijeve klijetke (LVEF) je procjenjivana u svih bolesnika (ultrazvukom ili radionuklidnom ventrikulografijom [MUGA]) prije početka liječenja lijekom Tyverb, kako bi se utvrdilo da je početna vrijednost unutar utvrđenih granica normalnih vrijednosti.
English: Proactive management of diarrhoea with anti-diarrhoeal medicinal product is important.
Croatian: Važno je proaktivno zbrinjavanje proljeva antidijaroicima.
English: Tyverb may be restarted at a reduced dose (750 mg/day when administered with trastuzumab, 1000 mg/day when administered with capecitabine or 1250 mg/day when administered with an aromatase inhibitor) after a minimum of 2 weeks and if the LVEF recovers to normal and the patient is asymptomatic.
Croatian: S primjenom lijeka Tyverb može se ponovno započeti smanjenom dozom (750 mg/dan kad se primjenjuje s trastuzumabom, 1000 mg/dan kada se primjenjuje s kapecitabinom ili 1250 mg/dan kada se primjenjuje s inhibitorom aromataze) nakon najmanje 2 tjedna te ako se vrijednost ejekcijske frakcije lijeve klijetke vrati u normalu, a bolesnik nema simptoma.
English: ITT population N
Croatian: Populacija planirana za liječenje N
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).
Croatian: Potrebno je izbjegavati istodobnu primjenu lijeka Tyverb i lijekova uske terapijske širine koji su supstrati CYP2C8 (npr. repaglinid) (vidjeti dijelove 4.4 i 5.2).
English: Co-administration of Tyverb with orally administered medicinal products with narrow therapeutic windows that are substrates of CYP3A4 and /or CYP2C8 should be avoided (see section 4.5).
Croatian: Potrebno je izbjegavati istodobnu primjenu lijeka Tyverb s lijekovima za peroralnu primjenu uske terapijske širine koji su supstrati CYP3A4 i/ili CYP2C8 (vidjeti dio 4.5).
English: Diarrhoea, including severe diarrhoea, has been reported with Tyverb treatment (see section 4.8).
Croatian: Prijavljeni su slučajevi proljeva, uključujući teški oblik proljeva, pri primjeni lijeka Tyverb (vidjeti dio 4.8).
English: Diarrhoea
Croatian: Anoreksija
English: Subjects who had received prior trastuzumab* N
Croatian: Ispitanici koji su prethodno primili trastuzumab* N
English: Each film-coated tablet contains lapatinib ditosylate monohydrate, equivalent to 250 mg lapatinib.
Croatian: Svaka filmom obložena tableta sadrži 250 mg lapatiniba u obliku lapatinibditosilat hidrata.
English: Tyverb should be discontinued if changes in liver function are severe and patients should not be retreated (see section 4.4).
Croatian: U slučaju teškog oštećenja funkcije jetre, primjenu lijeka Tyverb potrebno je prekinuti, a liječenje se ne smije više započinjati (vidjeti dio 4.4).
English: The recommended dose of Tyverb is 1500 mg (i.e. six tablets) once daily continuously.
Croatian: Preporučena doza lijeka Tyverb je 1500 mg (tj. šest tableta) jednom dnevno kontinuirano.
English: Median (95%
Croatian: Medijan (95% CI)