FrancophonIA/ELRC3.0 huggingface dataset:
English: †, back pain*
Croatian: †, bol u leđima*
English: In vitro studies indicate that lapatinib is a substrate for the transporters BCRP (ABCG1) and p-glycoprotein (ABCB1).
Croatian: In vitro ispitivanja pokazuju da je lapatinib supstrat za prijenosne proteine BCRP (ABCG1) i p-glikoprotein (ABCB1).
English: No overall differences in efficacy and safety of the combination of Tyverb and letrozole were observed between these patients and patients < 65 years of age.
Croatian: Sveukupno, nije primijećena razlika u djelotvornosti i sigurnosti primjene kombinacije Tyverba i letrozola između ovih bolesnica i bolesnica u dobi
English: The study was halted based on the results of a pre-specified interim analysis that showed an improvement in TTP for patients receiving Tyverb plus capecitabine.
Croatian: Ispitivanje je zaustavljeno na osnovi rezultata prespecificirane privremene analize koja je pokazala produljenje vremena do progresije bolesti za bolesnike koji su primali Tyverb plus kapecitabin.
English: What you need to know before you take Tyverb
Croatian: Što morate znati prije nego počnete uzimati Tyverb Nemojte uzimati Tyverb
English: Lapatinib inhibits CYP3A (Ki 0.6 to 2.3 µg/ml) and CYP2C8 (0.3 µg/ml) in vitro at clinically relevant concentrations.
Croatian: Lapatinib inhibira CYP3A (Ki 0,6 do 2,3 μg/ml) i CYP2C8 (0,3 μg/ml) in vitro u klinički značajnim koncentracijama.
English: 70 film-coated tablets 84 film-coated tablets 105 film-coated tablets 140 film-coated tablets
Croatian: 70 filmom obloženih tableta 84 filmom obložene tablete 105 filmom obloženih tableta 140 filmom obloženih tableta
English: Tyverb film-coated tablets are oval, biconvex, yellow film-coated, with ‘GS XJG' marked on one side.
Croatian: Tyverb filmom obložene tablete su ovalne, bikonveksne, žute filmom obložene tablete, s oznakom „GS XJG“ na jednoj strani.
English: (2500 mg/m2/day on days 1-14 every 21 days).
Croatian: (2500 mg/m2/dan od 1. do 14. dana svakih 21 dan).
English: telithromycin - medicines used to treat infections
Croatian: telitromicin - lijekovi koji se primjenjuju u liječenju infekcija
English: In the HER2-negative population, there was no benefit in PFS when letrozole plus Tyverb was compared with letrozole plus placebo (see Table 6).
Croatian: U populaciji HER2-negativnih ispitanica nije bilo dobiti u preživljenju bez progresije bolesti kada se uspoređivao letrozol plus Tyverb s letrozolom plus placebo (vidjeti Tablicu 6).
English: Median (95% CI) Stratified Hazard ratio b
Croatian: Medijan (95% CI) Stratificirani omjer hazarda b
English: Co-administration of lapatinib with intravenously administered docetaxel did not significantly affect the AUC or Cmax of either active substance.
Croatian: Istodobna primjena lapatiniba i intravenskog docetaksela nije značajno utjecala na AUC ili Cmax bilo koje od aktivnih supstanci.
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).
Croatian: Rezultati za farmakodinamičku populaciju (n=52) su bili konzistentni s onima iz ocjenjive populacije (maksimum ΔΔQTcF (90% CI) od 7,91 ms (4,13; 11,68) je zabilježen 10 sati nakon ingestije treće doze lapatiniba od 2000 mg).
English: The efficacy and safety of Tyverb in combination with capecitabine in breast cancer patients with good performance status was evaluated in a randomised, phase III study.
Croatian: Djelotvornost i sigurnost lijeka Tyverb u kombinaciji s kapecitabinom u bolesnika s rakom dojke dobrog općeg stanja procjenjivana je u fazi III randomiziranog ispitivanja.
English: OUTER CARTON (14 DAY, SINGLE PACK)
Croatian: VANJSKA KUTIJA (14 DANA, POJEDINAČNO PAKIRANJE)
English: Caution is advised in patients with severe renal impairment as there is no experience of Tyverb in this population (see section 5.2).
Croatian: Potreban je oprez u bolesnika s teškim oštećenjem funkcije bubrega obzirom da nema podataka o primjeni lijeka Tyverb u ovoj populaciji bolesnika (vidjeti dio 5.2).
English: Tyverb is also supplied in high density polyethylene bottles (HDPE) with a child resistant polypropylene closure containing 70, 84, 105 or 140 film-coated tablets.
Croatian: Tyverb je dostupan i u bocama od polietilena visoke gustoće (HDPE) s polipropilenskim zatvaračem sigurnim za djecu koje sadrže 70, 84, 105 ili 140 filmom obloženih tableta.
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.
Croatian: U zdravih dobrovoljaca koji su primali ketokonazol, koji je snažan inhibitor CYP3A4, pri dozi od 200 mg dvaput dnevno tijekom 7 dana, sistemska izloženost lapatinibu (100 mg dnevno) bila je povećana za oko 3,6 puta, a poluvijek je bio povećan za 1,7 puta.
English: Eligible patients were women with Stage IV ErbB2 gene amplified (or protein overexpressing) metastatic breast cancer who had been exposed to treatment with anthracyclines and taxanes.
Croatian: Prihvatljivi bolesnici bile su žene s metastatskim karcinomom dojke stadija IV s amplifikacijom ErbB2 gena (ili prekomjernom ekspresijom proteina), koje su bile izložene liječenju antraciklinima i taksanima.
English: • Your doctor will also carry out tests to check your heart and liver function before and during treatment with Tyverb.
Croatian: • Liječnik će Vam također raditi pretrage kako bi provjerio rad srca i jetre prije i tijekom liječenja lijekom Tyverb.
English: Response rate, % (95% CI)
Croatian: Stopa odgovora, % (95% CI)
English: LVEF decreases resolved or improved in more than 70 % of cases, in approximately 60 % of these on discontinuation of treatment with lapatinib, and in approximately 40 % of cases lapatinib was continued.
Croatian: Vrijednosti LVEF se vratila u raspon normalnih vrijednosti ili poboljšala u više od 70% slučajeva, od čega u oko 60% nakon prekida liječenja lapatinibom, a u oko 40% slučajeva se lapatinib nastavio primjenjivati.
English: Tell your doctor if you get a skin rash.
Croatian: Obavijestite svog liječnika ukoliko dobijete osip na koži.
English: Caution should be taken if Tyverb is to be administered to patients with conditions that could impair left ventricular function (including coadministration with potentially cardiotoxic medicinal products).
Croatian: Potreban je oprez pri primjeni lijeka Tyverb u bolesnika koji pate od stanja koja mogu oštetiti funkciju lijeve klijetke (uključujući istodobnu primjenu potencijalno kardiotoksičnih lijekova).
English: Discontinuation or interruption of dosing with Tyverb may be considered when a patient develops toxicity greater than or equal to grade 2 on the NCI CTCAE.
Croatian: Prekid ili pauza u liječenju lijekom Tyverb razmatra se kada bolesnik razvije toksičnost 2. ili višeg stupnja prema NCI CTCAE.
English: In rabbits, lapatinib was associated with maternal toxicity at 60 and 120 mg/kg/day (8% and 23% of the expected human clinical exposure, respectively) and abortions at 120 mg/kg/day.
Croatian: Kod kunića, lapatinib je bio povezan s toksičnošću za majke pri 60 i 120 mg/kg/dan (8% odnosno 23% očekivane kliničke izloženosti kod ljudi) te pobačajem pri 120 mg/kg/dan.
English: It is not known whether lapatinib is excreted in human milk.
Croatian: Nije poznato izlučuje li se lapatinib u majčino mlijeko u ljudi.
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.
Croatian: Lapatinib se nije pokazao klastogenim ili mutagenim u seriji analiza, uključujući analizu kromosomske aberacije kod kineskog hrčka, Amesov test, analizu kromosomske aberacije limfocita u ljudi i in vivo analizu kromosomske aberacije koštane srži u štakora.
English: Your doctor will advise you whether an alternative is available.
Croatian: Liječnik će Vam reći postoji li neki drugi lijek.
English: There is more advice on reducing the risk of skin rash at the end of section 4.
Croatian: Više informacija o načinima smanjivanja rizika za nastanak kožnog osipa pogledajte na kraju odjeljka 4.
English: Tell your doctor if any of these apply to you.
Croatian: Obavijestite svog liječnika ukoliko se nešto od navedenog odnosi na Vas.
English: EU/1/07/440/001 70 tablets EU/1/07/440/003 84 tablets
Croatian: EU/1/07/440/001 70 tableta EU/1/07/440/003 84 tableta
English: There are no adequate data from the use of Tyverb in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni lijeka Tyverb u trudnoći.
English: How to take Tyverb
Croatian: Kako uzimati Tyverb
English: Number of subjects who died Median overall survival, weeks Hazard Ratio (95% CI) p value
Croatian: Broj umrlih ispitanika Medijan ukupnog preživljenja, tjedni Omjer hazarda (95% CI) p vrijednost
English: Each pack of Tyverb contains 70 or 84 tablets in aluminium foil blisters of 10 or 12 tablets each.
Croatian: Svako pakiranje Tyverba sadrži 70 ili 84 tablete u blisterima od aluminijske folije, svaki sa 10 ili 12 tableta.
English: Co-administration of lapatinib with orally administered digoxin resulted in an approximate 80% increase in the AUC of digoxin.
Croatian: Istodobna primjena lapatiniba i peroralno primijenjenog digoksina rezultirala je povećanjem AUC za digoksin od približno 80%.
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).
Croatian: Lapatinib je također in vitro pokazao inhibiciju ovih efluksnih prijenosnih proteina, kao i jetrenog prijenosnog proteina za pohranu OATP 1B1 u klinički značajnim koncentracijama (IC50 vrijednosti bile su jednake 2,3 μg/ml).
English: • medicines that decrease stomach acidity - used to treat stomach ulcers or indigestion
Croatian: • lijekovi koji smanjuju kiselost želuca - koji se primjenjuju u liječenju čira na želucu ili probavnih smetnji.
English: Co-administration of Tyverb with moderate inhibitors of CYP3A4 should proceed with caution and clinical adverse reactions should be carefully monitored.
Croatian: Istodobnu primjenu lijeka Tyverb s umjerenim inhibitorima CYP3A4 potrebno je nastaviti s oprezom, uz pažljivo praćenje kliničkih nuspojava.
English: Effects of lapatinib on other medicinal products
Croatian: Učinci lapatiniba na druge lijekove
English: Lapatinib is a substrate for the transport proteins Pgp and BCRP.
Croatian: Lapatinib je supstrat za prijenosne proteine Pgp i BCRP.
English: Insufficient data are available in patients with hepatic impairment to provide a dose adjustment recommendation (see section 5.2).
Croatian: Ne postoje podaci o bolesnicima s oštećenjem funkcije jetre dostatni za izdavanje preporuka o prilagodbi doze (vidjeti dio 5.2).
English: • unusual hair loss or thinning
Croatian: • neuobičajen gubitak ili prorjeđivanje kose.
English: Each foil has a perforation down the middle and can be divided into two blisters with 5 or 6 tablets in each, depending on the pack size.
Croatian: Svaka folija ima perforaciju po sredini kao bi omogućila odvajanje u dva blistera od 5 ili 6 tableta, ovisno o veličini pakiranja.
English: There were no effects on male or female rat gonadal function, mating, or fertility at doses up to 120 mg/kg/day (females) and up to 180 mg/kg/day (males) (8 and 3 times the expected human clinical exposure, respectively).
Croatian: Nije bilo učinaka na funkciju gonada, parenje ili plodnost mužjaka ili ženke štakora pri dozama do 120 mg/kg/dan (ženke) i do 180 mg/kg/dan (mužjaci) (8 odnosno 3 puta više od očekivane kliničke izloženosti).
English: Effects of other medicinal products on lapatinib
Croatian: Učinci drugih lijekova na lapatinib
English: Tyverb is for oral use.
Croatian: Način primjene Tyverb je za peroralnu primjenu.
English: Also tell your doctor immediately if your diarrhoea worsens.
Croatian: Također bez odlaganja obavijestite svog liječnika ako se proljev pogorša.
English: Administration of Tyverb to patients with moderate to severe hepatic impairment should be undertaken with caution due to increased exposure to the medicinal product.
Croatian: Primjenu lijeka Tyverb u bolesnika s umjerenim do teškim oštećenjem funkcije jetre potrebno je provoditi s oprezom zbog povećane izloženosti lijeku.
English: Breast-feeding must be discontinued in women who are receiving therapy with Tyverb and for at least 5 days after the last dose.
Croatian: Dojenje se mora prekinuti kod žena koje se liječe lijekom Tyverb i još najmanje 5 dana nakon posljednje doze.
English: Serious cutaneous reactions, including Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)** Musculoskeletal and connective tissue disorders Very common Pain in extremity*
Croatian: Ozbiljne kožne reakcije, uključujući Stevens Johnsonov sindrom (SJS) i toksičnu epidermalnu nekrolizu (TEN)**.
English: Diarrhoea was the most common adverse reaction resulting in discontinuation of treatment when lapatinib was administered in combination with capecitabine, or with letrozole.
Croatian: Proljev je bio najčešća nuspojava koja je rezultirala prekidom liječenja pri primjeni lapatiniba u kombinaciji s kapecitabinom ili s letrozolom.
English: Patients eligible for enrolment had HER2-overexpressing, locally advanced or metastatic breast cancer, progressing after prior treatment that included taxanes, anthracyclines and trastuzumab.
Croatian: Bolesnici koji su ispunjavali kriterije za uključivanje pokazivali su prekomjernu ekspresiju HER2, imali su lokalno uznapredovao ili metastatski rak dojke, koji je napredovao nakon prethodnog liječenja koje je uključivalo taksane, antracikline i trastuzumab.
English: Tell your doctor if your diarrhoea continues.
Croatian: Obavijestite svog liječnika ukoliko se proljev nastavi.
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.
Croatian: Proljev izazvan lijekom Tyverb najčešće je niskog stupnja, dok se teški proljev 3. ili 4. stupnja prema NCI CTCAE pojavljuje u < 10%, odnosno < 1% bolesnika.
English: Do not breast-feed while taking Tyverb and for at least 5 days after the last dose.
Croatian: Nemojte dojiti ako uzimate Tyverb i još najmanje 5 dana nakon posljednje doze.
English: Randomisation was stratified by sites of disease and by time from discontinuation of prior adjuvant anti-oestrogen therapy.
Croatian: Bolesnice su randomizirane prema sijelu bolesti i prema vremenu od prekida prethodnog adjuvantnog antiestrogenskog liječenja.
English: The recommended dose of trastuzumab is 4 mg/kg administered as an intravenous loading dose, followed by 2 mg/kg intravenous weekly (see section 5.1).
Croatian: Preporučena doza trastuzumaba je 4 mg/kg, a primjenjuje se intravenski kao udarna doza, nakon čega slijedi intravenska doza od 2 mg/kg tjedno (vidjeti dio 5.1).
English: • quinidine, digoxin - medicines used to treat certain heart problems
Croatian: • kinidin, digoksin - lijekovi koji se primjenjuju u liječenju određenih problema sa srcem
English: The efficacy and safety of lapatinib in combination with trastuzumab in metastatic breast cancer were evaluated in a randomised trial.
Croatian: Djelotvornost i sigurnost lapatiniba u kombinaciji s trastuzumabom u liječenju metastatskog karcinoma dojke ocijenjeni su u randomiziranom ispitivanju.
English: Number (%) with event Kaplan-Meier estimate, months a
Croatian: Kaplan-Meier procjena, mjeseci a
English: If you get other side effects
Croatian: Ako primijetite druge nuspojave
English: The solubility of lapatinib is pH-dependent.
Croatian: Topljivost lapatiniba ovisna je o pH.
English: Please refer to the full prescribing information of trastuzumab.
Croatian: Molimo pogledajte cjelokupne informacije o propisivanju trastuzumaba.
English: Because of the possible side effects of Tyverb, your ability to drive or operate machines could be affected.
Croatian: Zbog mogućih nuspojava lijeka Tyverb može doći do utjecaja na sposobnost upravljanja vozilima ili rada na strojevima.
English: In addition, per the protocol, patients were to be reported by the investigators as having progressed on their most recent trastuzumab containing regimen in the metastatic setting.
Croatian: Osim toga, sukladno planu ispitivanja, ispitivači su morali prijaviti je li bolesnicima u metastatskom okruženju bolest progredirala na posljednjoj terapiji koja sadrži trastuzumab.
English: Available data suggest that no dose adjustment is necessary in patients with mild to moderate renal impairment.
Croatian: Dostupni podaci pokazuju da nije potrebna prilagodba doze u bolesnika s blagim do umjerenim oštećenjem funkcije bubrega.
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.
Croatian: U ocjenjivoj populaciji (n=37), maksimalna srednja vrijednost ΔΔQTcF (90% CI) od 8,75 ms (4,08; 13,42) je zabilježena 10 sati nakon ingestije treće doze lapatiniba od 2000 mg.
English: The safe use of Tyverb during breast-feeding has not been established.
Croatian: Sigurna primjena lijeka Tyverb tijekom dojenja nije utvrđena.
English: Table 1 Time to progression data from Study EGF100151 (Tyverb / capecitabine)
Croatian: Tablica 1 Vrijeme do progresije, podaci iz ispitivanja EGF100151 (Tyverb / kapecitabin)
English: Headache*
Croatian: Glavobolja*
English: PFS = progression-free survival; CI = confidence interval.
Croatian: Omjer hazarda (95% CI) P vrijednost PFS = preživljenje bez progresije; CI = interval pouzdanosti.
English: 8.9 mos (6.7, 11.8)
Croatian: 8,9 mjeseci (6,7; 11,8)
English: • cisapride - a medicine used to treat certain digestive system problems
Croatian: • cisaprid - lijek koji se primjenjuje u liječenju određenih problema probavnog sustava
English: Your doctor also needs to know before you take Tyverb:
Croatian: Prije nego počnete uzimati Tyverb Vaš liječnik također mora znati:
English: Very common Hot flush Respiratory, thoracic and mediastinal disorders Very common Epistaxis
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Vrlo često
English: Lapatinib inhibits ErbB-driven tumour cell growth in vitro and in various animal models.
Croatian: Lapatinib inhibira rast tumorskih stanica potaknut ErbB-om in vitro i na raznim životinjskim modelima.
English: Co-administration of Tyverb with orally administered midazolam resulted in an approximate 45% increase in the AUC of midazolam.
Croatian: Istodobna primjena lijeka Tyverb s oralnim midazolamom rezultira u povećanju AUC midazolama za približno 45%.
English: It is not known whether Tyverb passes into breast-milk.
Croatian: Nije poznato izlučuje li se Tyverb u majčino mlijeko.
English: Tyverb has been studied in combination with letrozole for the treatment of postmenopausal women with hormone receptor-positive (oestrogen receptor [ER] positive and / or progesterone receptor [PgR] positive) advanced or metastatic breast cancer.
Croatian: Tyverb je ispitivan u kombinaciji s letrozolom za liječenje hormonski pozitivnog (estrogen receptor [ER] pozitivni i/ili progesteron receptor [PgR] pozitivni) uznapredovalog ili metastatskog karcinoma dojke u postmenopauzalnih žena.
English: Lapatinib pharmacokinetics have not been specifically studied in patients with renal impairment or in patients undergoing haemodialysis.
Croatian: Farmakokinetika lapatiniba nije specifično ispitivana u bolesnika s oštećenjem funkcije bubrega ili u bolesnika na hemodijalizi.
English: LVEF should continue to be evaluated during treatment with Tyverb to ensure that LVEF does not decline to an unacceptable level (see section 4.2).
Croatian: Ejekcijska frakcija lijeve klijetke se procjenjuje tijekom liječenja lijekom Tyverb kako bi se utvrdilo da se ne smanjuje na neprihvatljivu razinu (vidjeti dio 4.2).
English: Tyverb / aromatase inhibitor combination posology Each pack of Tyverb contains 84 film-coated tablets in foil blisters (polyamide / aluminium / polyvinyl chloride / aluminium) of 12 tablets each.
Croatian: Doziranje kombinacije Tyverb / inhibitor aromataze Svako pakiranje lijeka Tyverb sadrži 84 filmom obložene tablete u blisterima od folije (poliamid/ aluminij/ polivinilklorid/ aluminij), po 12 tableta u svakom.
English: Co-administration of Tyverb with strong inhibitors of CYP3A4 (e.g. ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole, nefazodone) should be avoided.
Croatian: Potrebno je izbjegavati istodobnu primjenu lijeka Tyverb sa snažnim inhibitorima CYP3A4 (npr. ritonavir, sakvinavir, telitromicin, ketokonazol, itrakonazol, vorikonazol, posakonazol, nefazodon).
English: No additional adverse reactions were reported to be associated with lapatinib in combination with trastuzumab.
Croatian: Nisu prijavljene dodatne nuspojave povezane s lapatinibom primijenjenim u kombinaciji s trastuzumabom.
English: Symptomatic LVEF decreases were observed in approximately 0.3% of patients who received lapatinib.
Croatian: Simptomatsko smanjenje LVEF zabilježeno je u oko 0,3% bolesnika koji su primali lapatinib.
English: In oral carcinogenicity studies with lapatinib, severe skin lesions were seen at the highest doses tested which produced exposures based on AUC up to 2-fold in mice and male rats, and up to 15-fold in female rats, compared to humans given 1250 mg of lapatinib once daily.
Croatian: U ispitivanjima kancerogenosti najviših ispitivanih doza oralnog lapatiniba koje su rezultirale s AUC do 2 puta većom u miševa i mužjaka štakora te do 15 puta većom u ženki štakora primijećene su teške kožne lezije, u usporedbi s 1250 mg lapatiniba primijenjenog jednom dnevno u ljudi.
English: • pimozide - a medicine used to treat certain mental health problems
Croatian: • pimozid - lijek koji se primjenjuje u liječenju određenih psihičkih poremećaja
English: In the rat preand postnatal development study, a decrease in pup survival occurred between birth and postnatal day 21 at doses of 60 mg/kg/day or higher (5 times the expected human clinical exposure).
Croatian: Ispitivanja pre- i postnatalnog razvoja kod štakora pokazala su smanjenje u stopi preživljenja mladunčadi u razdoblju između poroda i 21. dana nakon poroda pri dozama od 60 mg/kg/dan ili više (5 puta više od očekivane kliničke izloženosti kod ljudi).
English: tyverb 250 mg [folding box only]
Croatian: tyverb 250 mg [samo kutija]
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).
Croatian: Primjenu lijeka Tyverb potrebno je prekinuti u bolesnika s proljevom 3. stupnja prema NCI CTCAE ili 1. ili 2. stupnja s obilježjima komplikacija (umjereni do teški grčevi u trbuhu, mučnina ili povraćanje 2. ili višeg stupnja prema NCI CTCA, smanjena funkcionalna sposobnost, vrućica, sepsa, neutropenija, svježa krv u stolici ili dehidracija) (vidjeti dijelove 4.4 i 4.8).
English: Please refer to the full prescribing information of capecitabine.
Croatian: Molimo pogledajte cjelokupne informacije o propisivanju kapecitabina.
English: Caution should be exercised when dosing lapatinib concurrently with medicinal products with narrow therapeutic windows that are substrates of Pgp, and a reduction in the dose of the Pgp substrate should be considered.
Croatian: Potreban je oprez kada se lapatinib primjenjuje istodobno s lijekovima uske terapijske širine koji su supstrati za Pgp, a smanjivanje doze
English: Decreased left ventricular ejection fraction and QT interval prolongation
Croatian: Smanjena ejekcijska frakcija lijeve klijetke i produljenje QT intervala