FrancophonIA/ELRC3.0 huggingface dataset:
English: There is no specific antidote for the inhibition of EGFR (ErbB1) and/or HER2 (ErbB2) tyrosine phosphorylation.
Slovenian: Specifičnega antidota za zaviranje EGFR (ErbB1) in/ali HER2 (ErbB2) tirozinske fosforilacije ni.
English: HER2 (ErbB2) overexpressing tumours are defined by IHC3+, or IHC2+ with gene amplification or gene amplification alone.
Slovenian: Tumorji s prekomerno ekspresijo HER2 (ErbB2) so opredeljeni z IHC3+ ali IHC2+ in amplifikacijo gena ali amplifikacijo gena samo.
English: The effect on human fertility is unknown.
Slovenian: Vpliv na plodnost pri človeku ni znan.
English: There were 952 patients with HER2-negative tumours, and a total of 115 patients whose tumour HER2 status was unconfirmed (no tumour sample, no assay result, or other reason).
Slovenian: 952 bolnic je imelo HER2negativne tumorje, pri 115 bolnicah pa HER2-status tumorja ni bil potrjen (ni bilo vzorca tumorja, ni bilo rezultata preizkusa ali zaradi drugih razlogov).
English: EU/1/07/440/004 70 tablets EU/1/07/440/005 140 tablets EU/1/07/440/006 84 tablets EU/1/07/440/007 105 tablets
Slovenian: EU/1/07/440/004 70 tablet EU/1/07/440/005 140 tablet EU/1/07/440/006 84 tablet EU/1/07/440/007 105 tablet
English: Tell your doctor or pharmacist if you notice any side effects not listed in this leaflet.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu.
English: • avoid herbal supplements (some may cause diarrhoea).
Slovenian: • izogibajte se zeliščnim dodatkom (nekateri od njih lahko povzročijo drisko).
English: b. P-value from Cox regression model, stratifying for site of disease and prior anti-adjuvant therapy at screening.
Slovenian: b. Vrednost p iz Coxovega regresijskega modela, stratificirano za mesto bolezni in predhodno anti-adjuvantno zdravljenje ob presejanju.
English: Peak plasma concentrations (Cmax) of lapatinib are achieved approximately 4 hours after administration.
Slovenian: Najvišje plazemske koncentracije (Cmax) lapatiniba so dosežene približno 4 ure po uporabi.
English: What you need to know before you take Tyverb
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Tyverb
English: A detrimental effect on such activities cannot be predicted from the pharmacology of lapatinib.
Slovenian: Škodljivega vpliva na tovrstne aktivnosti iz farmakologije lapatiniba ni mogoče predvideti.
English: • irregular heart-beat (change in the electrical activity of the heart)
Slovenian: • neenakomeren srčni utrip (sprememba v električni aktivnosti srca),
English: There is more advice on reducing the risk of skin rash at the end of section 4.
Slovenian: Več nasvetov o zmanjšanju tveganja izpuščaja na koži je na koncu poglavja 4.
English: PFS event is Progressed or Died and OS event is Died due to any cause.
Slovenian: Dogodek PFS je "napredovanje" ali "smrt", dogodek OS pa "smrt zaradi kakršnega koli vzroka".
English: Prescribing physicians are advised to perform a skin examination prior to treatment and regularly during treatment.
Slovenian: Zdravniki, ki predpisujejo to zdravilo, morajo pregled kože opraviti pred zdravljenjem in ga izvajati redno med zdravljenjem.
English: However, a few cases of acute renal failure have been reported secondary to severe dehydration due to diarrhoea.
Slovenian: Vendar je bilo opisanih nekaj primerov akutne odpovedi ledvic po hudi dehidraciji zaradi driske.
English: Of the 148 patients who received monotherapy treatment, 77 (52%) patients elected at the time of disease progression to receive combination treatment.
Slovenian: Od 148 bolnic, ki so prejemale monoterapijo, se jih je 77 (52 %) ob napredovanju bolezni odločilo za kombinirano zdravljenje.
English: • an effect on how your heart works
Slovenian: • vpliv na delovanje srca.
English: There was an increased incidence of cardiac toxicity, but these events were comparable in nature and severity to those reported from the lapatinib clinical programme (see section 4.4cardiac toxicity).
Slovenian: Incidenca kardiotoksičnih učinkov se je povečala, vendar so bili ti dogodki po naravi in izrazitosti primerljivi tistim, ki so bili opisani v kliničnem programu lapatiniba (glejte poglavje 4.4kardiotoksičnost).
English: If you do experience symptoms associated with this side effect, these are likely to include an irregular heartbeat and shortness of breath.
Slovenian: Če se pojavijo simptomi, povezani s tem neželenim učinkom, sta med njimi verjetna neredno bitje srca in kratka sapa.
English: • liver problems, which may cause itching, yellow eyes or skin (jaundice), or dark urine or pain or discomfort in the right upper area of the stomach.
Slovenian: • težave z jetri, ki lahko povzročijo srbenje, rumeno obarvanje očesnih beločnic ali kože (zlatenica), temen urin ali bolečino ali nelagodje v zgornjem desnem predelu trebuha.
English: Diarrhoea can be potentially life-threatening if accompanied by dehydration, renal insufficiency, neutropenia and/or electrolyte imbalances and fatal cases have been reported.
Slovenian: Driska je lahko smrtno nevarna, če jo spremljajo dehidracija, insuficienca ledvic, nevtropenija in/ali neravnovesje elektrolitov; opisani so bili primeri s smrtnim izidom.
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.
Slovenian: V kliničnih študijah so vrednost LVEF nadzirali v približno osemtedenskih intervalih med zdravljenjem z zdravilom Tyverb, da so zagotovili, da se vrednost ni zmanjšala pod spodnjo mejo normalne vrednosti.
English: A summary of efficacy endpoints and overall survival data is provided in Table 4.
Slovenian: Povzetek opazovanih dogodkov učinkovitosti in podatkov o celokupnem preživetju je prikazan v preglednici 4.
English: A randomised Phase III study (EGF111438) (N=540) compared the effect of the two regimens on the incidence of CNS as site of first relapse in women with HER2 overexpressing metastatic breast cancer.
Slovenian: Randomizirana študija III. faze (EGF111438) (n=540) je primerjala učinek obeh shem na incidenco osrednjega živčevja kot mesta prvega relapsa pri ženskah z metastatskim rakom dojke s čezmerno ekspresijo HER2.
English: The effect of lapatinib on the QT-interval was evaluated in a single-blind, placebo-controlled, single sequence (placebo and active treatment) crossover study in patients with advanced solid tumours (EGF114271) (n=58).
Slovenian: Učinek lapatiniba na interval QT so ocenjevali v enojno slepi, s placebom kontrolirani navzkrižni študiji z enim zaporednim zdravljenjem (placebo in aktivno zdravilo) pri bolnikih z napredovalimi solidnimi tumorji (v študiji EGF114271) (n=58).
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.
Slovenian: Študija je bila prekinjena na osnovi rezultatov vnaprej določene začasne analize, ki je pokazala izboljšanje časa do progresije pri bolnikih, ki so prejemali zdravilo Tyverb in kapecitabin.
English: • unusual wheezing, or difficulty in breathing
Slovenian: • neobičajno sopenje ali težko dihanje,
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).
Slovenian: Kadar se lapatinib jemlje v kombinaciji z močnim zaviralcem CYP3A4 se lahko pričakuje podaljšanje QTc intervala za 16,1 ms (12,6 - 20,3 ms), kot je pokazala napoved na osnovi modela (glejte poglavje 4.4).
English: At ≥60 mg/kg/day there were decreased foetal body weights, and minor skeletal variations.
Slovenian: Pri odmerkih ≥ 60 mg/kg/dan so poročali o zmanjšani telesni masi plodov in manjših skeletnih odstopanjih.
English: Data have shown that Tyverb combined with chemotherapy is less effective than trastuzumab when combined with chemotherapy.
Slovenian: Podatki so pokazali, da je zdravilo Tyverb v kombinaciji s kemoterapijo manj učinkovito kot trastuzumab v kombinaciji s kemoterapijo.
English: Dose delay and dose reduction
Slovenian: Odložitev zdravljenja in zmanjšanje odmerka
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.
Slovenian: Lapatinib je ohranil pomembno delovanje proti celičnim linijam raka dojke z amplifikacijo gena HER2, izbranim za dolgotrajno rast v mediju s trastuzumabom in vitro, ter je pri teh celičnih linijah deloval sinergistično v kombinaciji s trastuzumabom.
English: Pre-treatment with a proton pump inhibitor (esomeprazole) decreased lapatinib exposure by an average of 27% (range: 6% to 49%).
Slovenian: Predhodno zdravljenje z inhibitorjem protonske črpalke (esomeprazol) zmanjša izpostavljenost lapatinibu za povprečno 27 % (od 6 % do 49 %).
English: Your doctor will decide on the correct dose of Tyverb depending on the type of breast cancer being treated.
Slovenian: Zdravnik bo določil za vas pravi odmerek zdravila Tyverb glede na vrsto zdravljenega raka dojke.
English: • If you are pregnant or planning to become pregnant, tell your doctor.
Slovenian: • Če ste noseči ali nameravate zanositi, to povejte svojemu zdravniku.
English: Lapatinib has not been evaluated in patients with symptomatic cardiac failure.
Slovenian: Lapatiniba niso ocenjevali pri bolnikih s simptomatskim srčnim popuščanjem.
English: Diarrhoea generally occurs early during Tyverb treatment, with almost half of those patients with diarrhoea first experiencing it within 6 days.
Slovenian: Driska se po navadi pojavi zgodaj med zdravljenjem z zdravilom Tyverb; pri skoraj polovici teh bolnikov z drisko se je prvič pojavila v 6 dneh.
English: Final OS analysis (post-hoc analysis, 07 August 2013) Median follow-up (yrs) Deaths (%) Hazard ratio (95% CI), p-value Median values from Kaplan-Meier analysis; HR and p-values from Cox regression models adjusting for important prognostic factors.
Slovenian: Končna analiza celokupnega preživetja (post-hoc analiza, 07. avgust 2013) Mediano spremljanje (leta) Smrti (%) Razmerje ogroženosti (95 % IZ), vrednost p Mediane vrednosti iz Kaplan-Meierjeve analize; Razmerje ogroženosti in vrednosti p iz Coxovega regresijskega modela, korigirano za pomembne prognostične dejavnike.
English: During the 4-day treatment period, three doses of matching placebo were administered 12 hours apart in the morning and evening on Day 1 and in the morning on Day 2.
Slovenian: V 4-dnevnem obdobju zdravljenja so bolnikom odmerili tri odmerke ustreznega placeba z 12-urnim presledkom, in sicer 1. dan zjutraj in zvečer ter 2. dan zjutraj.
English: The study was halted as the interim analysis (N=475) showed a low incidence of CNS events and, superior efficacy of the trastuzumab plus capecitabine arm in terms of progression-free survival and overall survival (see results of final analysis in Table 3).
Slovenian: Študijo so ustavili, ko je vmesna analiza (n=475) pokazala majhno incidenco dogodkov na osrednjem živčevju in superiorno učinkovitost v kraku s kombinacijo trastuzumaba in kapecitabina glede preživetja brez napredovanja in celotnega preživetja (glejte rezultate končne analize v preglednici 3).
English: Your doctor will advise you about the dose of your other anti-cancer medicine, and how to take it.
Slovenian: Zdravnik vam bo povedal tudi za odmerek drugega zdravila proti raku in kako morate jemati to drugo zdravilo.
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).
Slovenian: - Druge sestavine so: mikrokristalna celuloza, povidon (K30), natrijev karboksimetilškrob (vrsta A), magnezijev stearat, hipromeloza, titanov dioksid (E171), makrogol (400), polisorbat 80, rumeni železov oksid (E172) in rdeči železov oksid (E172).
English: Bottles 3 years
Slovenian: Plastenke 3 leta
English: Inhibitors (ketoconazole, itraconazole, quinidine, verapamil, cyclosporine, and erythromycin) and inducers (rifampicin and St John's Wort) of these proteins may alter the exposure and/or distribution of lapatinib (see section 5.2).
Slovenian: Zaviralci (ketokonazol, itrakonazol, kinidin, verapamil, ciklosporin in eritromicin) in induktorji (rifampicin in šentjanževka) teh proteinov lahko spremenijo izpostavljenost in/ali porazdelitev lapatiniba (glejte poglavje 5.2).
English: Patients should be instructed to promptly report any change in bowel patterns.
Slovenian: Bolnikom je treba naročiti, naj takoj sporočijo kakršnekoli spremembe v ritmu odvajanja.
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.
Slovenian: Farmakokinetiko lapatiniba so raziskovali pri bolnikih z zmerno (n = 8) ali hudo (n = 4) okvaro jeter (ocena po Child-Pugh-u 7-9 oziroma večja od 9) in 8 zdravih kontrolnih bolnikih.
English: Investigator analysis on data at the end of enrolment is presented in Table 1.
Slovenian: Analiza podatkov, ki so jo naredili raziskovalci, je predstavljena v tabeli 1.
English: Tyverb has no influence on the ability to drive and use machines.
Slovenian: Zdravilo Tyverb nima vpliva na sposobnost vožnje in upravljanja strojev.
English: What Tyverb is and what it is used for What you need to know before you take Tyverb How to take Tyverb
Slovenian: Kaj je zdravilo Tyverb in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Tyverb Kako jemati zdravilo Tyverb Možni neželeni učinki
English: Component of a multipack, cannot to be sold separately.
Slovenian: Sestavni deli pakiranja po več enot ne smejo biti v prometu kot samostojna enota.
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.
Slovenian: Neodvisna ocena podatkov je tudi pokazala, da je zdravilo Tyverb pri uporabi v kombinaciji s kapecitabinom pomembno podaljšal čas do progresije (razmerje tveganj 0,57 [95 % interval zaupanja 0,43; 0,77] p=0,0001) v primerjavi s kapecitabinom samim.
English: In the HER2-overexpressing population, only 2 patients were enrolled who had received prior trastuzumab, 2 patients had received prior aromatase inhibitor therapy, and approximately half had received tamoxifen.
Slovenian: V populaciji s čezmerno ekspresijo HER2 sta bili vključeni le 2 bolnici, ki sta predhodno prejemali trastuzumab, 2 bolnici sta predhodno prejemali zaviralec aromataze in približno pol bolnic je prejemalo tamoksifen.
English: If you forget to take Tyverb
Slovenian: Če ste pozabili vzeti zdravilo Tyverb
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.
Slovenian: Vsak pretisni omot je po sredini preluknjan in ga je mogoče razdeliti na dva pretisna omota s 5 ali 6 tabletami, odvisno od velikosti pakiranja.
English: • topotecan, paclitaxel, irinotecan, docetaxel - medicines used to treat certain types of cancer
Slovenian: • topotekan, paklitaksel, irinotekan, docetaksel - zdravila za zdravljenje nekaterih vrst raka,
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.
Slovenian: Sok grenivke lahko zavre CYP3A4 v črevesni steni in poveča biološko uporabnost lapatiniba, zato se mu je med zdravljenjem z zdravilom Tyverb treba izogibati.
English: Randomisation was stratified by prior trastuzumab treatment and number of prior treatments for metastatic disease.
Slovenian: Randomizacija je bila stratificirana po predhodnem zdravljenju s trastuzumabom in številom predhodnih zdravljenj zaradi metastatske bolezni.
English: However, daily dosing of lapatinib results in achievement of steady state within 6 to 7 days, indicating an effective half-life of 24 hours.
Slovenian: Pri dnevnem odmerjanju lapatiniba je stanje dinamičnega ravnovesja doseženo v 6 do 7 dneh, kar kaže efektivni razpolovni čas 24 ur.
English: Lapatinib is highly bound (greater than 99%) to albumin and alpha-1 acid glycoprotein.
Slovenian: Lapatinib se v velikem obsegu (več kot 99 %) veže na albumin in alfa-1 kisli glikoprotein.
English: You are responsible to decide if you are able to drive a motor vehicle or perform other tasks that require increased concentration.
Slovenian: O svojih sposobnostih za vožnjo motornih vozil ali opravljanje opravil, ki zahtevajo zbranost, morate presoditi sami.
English: Subgroup analysis results based on predefined stratification factor (hormone receptor status) is also shown in Table 5.
Slovenian: Preglednica 5 prikazuje tudi analizo rezultatov podskupin po vnaprej opredeljenem stratifikacijskem dejavniku (stanje hormonskih receptorjev).
English: The most common adverse reactions (>25%) during therapy with lapatinib were gastrointestinal events (such as diarrhoea, nausea, and vomiting) and rash.
Slovenian: Najpogostejši neželeni učinki (> 25 %) med zdravljenjem z lapatinibom so bili gastrointestinalni učinki (npr. driska, navzea in bruhanje) in izpuščaj.
English: Effects of lapatinib on other medicinal products
Slovenian: Vpliv lapatiniba na druga zdravila
English: Lapatinib alone (N=148 )
Slovenian: Lapatinib sam (N=148)
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).
Slovenian: Lapatinib ni pomembneje zaviral naslednjih encimov v humanih jetrnih mikrosomih: CYP1A2, CYP2C9, CYP2C19 in CYP2D6 ali UGT encimov (in vitro IC50 vrednosti so bile večje ali enake 6,9 µg/ml).
English: Diarrhoea responds well to proactive management (see section 4.4).
Slovenian: Driska se je dobro odzvala na proaktivno zdravljenje (glejte poglavje 4.4).
English: Ventricular arrhythmias/Torsades de Pointes, electrocardiogram QT prolonged**
Slovenian: Pogostnost neznana ventrikularne aritmije/torsades de pointes, podaljšanje intervala QT na elektrokardiogramu**
English: In a single case of a patient who took 9000 mg of Tyverb, sinus tachycardia (with otherwise normal ECG) was also observed.
Slovenian: Pri enem samem bolniku, ki je vzel 9.000 mg zdravila Tyverb, so zabeležili tudi sinusno tahikardijo (s sicer normalnim EKG).
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.
Slovenian: Previdnost je potrebna v primeru sočasne uporabe lapatiniba in zdravil z ozkim terapevtskim oknom, ki so substrati Pgp; razmisliti je treba o zmanjšanju odmerka substrata Pgp.
English: The patients in the registration study were not previously treated with trastuzumab or an aromatase inhibitor (see sections 4.4. and 5.1).
Slovenian: Bolnice v registracijski študiji predhodno niso bile zdravljene s trastuzumabom ali zaviralcem aromataze (glejte poglavji 4.4 in 5.1).
English: Observed adverse reactions included dyspnoea, cardiac failure and palpitations.
Slovenian: Opaženi neželeni učinki so vključevali dispnejo, srčno popuščanje in palpitacije.
English: In studies across the clinical development programme for lapatinib, cardiac events including LVEF decreases were reported in approximately 1% of patients.
Slovenian: V študijah, izvedenih v programu kliničnega razvoja lapatiniba, so bili dogodki na srcu (vključno z zmanjšanjem LVEF) opisani pri približno 1 % bolnikov.
English: Proactive management of diarrhoea with anti-diarrhoeal medicinal product is important.
Slovenian: Pomembno je proaktivno zdravljenje driske z antidiaroiki.
English: An additional increase in peak exposure of lapatinib can be expected when lapatinib is taken repeatedly with food (see sections 4.2 and 5.2) or concomitantly with strong CYP3A4 inhibitors.
Slovenian: Dodatno povečanje največje izpostavljenosti lapatinibu se pričakuje pri ponavljajočem jemanju lapatiniba s hrano (glejte poglavji 4.2 in 5.2) in pri sočasnem jemanju z močnimi zaviralci CYP3A4.
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%.
Slovenian: Pri zdravih prostovoljcih, ki so prejemali karbamazepin, induktor CYP3A4, v odmerku 100 mg dvakrat na dan 3 dni in 200 mg dvakrat na dan 17 dni, se je sistemska izpostavljenost lapatinibu zmanjšala za približno 72 %.
English: Progression-free survival (PFS) was the primary endpoint of the study with response rate and overall survival (OS) as secondary endpoints.
Slovenian: Preživetje brez napredovanja (PFS-progression-free survival) je bilo primarni opazovani dogodek v študiji, delež odziva in celokupno preživetje (OS-overall survival) pa sta bila sekundarna opazovana dogodka.
English: OUTER CARTON (14 DAY PACK, PART OF 28 DAY MULTIPACK without blue box)
Slovenian: ŠKATLA (PAKIRANJE ZA 14-DNEVNO ZDRAVLJENJE, SESTAVNI DEL PAKIRANJA PO VEČ ENOT ZA 28-DNEVNO ZDRAVLJENJE brez modrega okenca)
English: Each film-coated tablet contains lapatinib ditosylate monohydrate, equivalent to 250 mg lapatinib.
Slovenian: Ena filmsko obložena tableta vsebuje lapatinibijev ditosilat monohidrat, kar ustreza 250 mg lapatiniba.
English: • Take Tyverb either at least one hour before or at least one hour after food.
Slovenian: • Zdravilo Tyverb vzemite vsaj eno uro pred ali vsaj eno uro po obroku ali prigrizku.
English: Your doctor will check your skin before and during treatment.
Slovenian: Zdravnik vam bo pred zdravljenjem in med zdravljenjem preverjal stanje kože.
English: Tyverb is indicated for the treatment of adult patients with breast cancer, whose tumours overexpress HER2 (ErbB2);
Slovenian: Zdravilo Tyverb je indicirano za zdravljenje odraslih bolnikov z rakom dojke s prekomerno izraženimi HER2 (ErbB2):
English: The relevance of these findings for humans is uncertain.
Slovenian: Pomen teh izsledkov za človeka ni gotov.
English: Measurements, including electrocardiograms (ECGs) and pharmacokinetic samples, were taken at baseline and at the same time points on Day 2 and Day 4.
Slovenian: Meritve, vključno s snemanjem elektrokardiograma (EKG), in jemanje vzorcev za farmakokinetične analize so opravili ob izhodišču in ob enakih časovnih točkah na 2. in 4. dan.
English: The safe use of Tyverb during breast-feeding has not been established.
Slovenian: Varnost uporabe zdravila Tyverb med dojenjem ni bila dokazana.
English: Systemic exposure (AUC) to lapatinib after a single oral 100 mg dose increased approximately 56% and 85% in patients with moderate and severe hepatic impairment, respectively.
Slovenian: Sistemska izpostavljenost (AUC) lapatinibu po enkratnem peroralnem odmerku 100 mg lapatiniba se je pri bolnikih z zmerno okvaro jeter povečala za približno 56 %, pri bolnikih s hudo okvaro jeter pa za 85 %.
English: Blister packs 2 years
Slovenian: Pretisni omoti 2 leti
English: Lapatinib was studied in pregnant rats and rabbits given oral doses of 30, 60, and 120 mg/kg/day.
Slovenian: Lapatinib so raziskovali pri brejih podganah in kunčicah, ki so ga prejemale peroralno v odmerkih 30, 60 in 120 mg/kg/dan.
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).
Slovenian: Poleg tega je, odvisno od vrste hrane, biološka uporabnost približno 2- do 3-krat večja pri uporabi lapatiniba 1 uro po jedi v primerjavi z uporabo lapatiniba 1 uro pred prvim dnevnim obrokom (glejte poglavji 4.2 in 5.2).