natgillin/translations-raw huggingface dataset:
Of the 148 patients who received monotherapy treatment, 77 (52%) patients elected at the time of disease progression to receive combination treatment. 
Od 148 bolnic, ki so prejemale monoterapijo, se jih je 77 (52 %) ob napredovanju bolezni odločilo za kombinirano zdravljenje.
• an effect on how your heart works 
• vpliv na delovanje srca.
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). 
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).
If you do experience symptoms associated with this side effect, these are likely to include an irregular heartbeat and shortness of breath. 
Če se pojavijo simptomi, povezani s tem neželenim učinkom, sta med njimi verjetna neredno bitje srca in kratka sapa.
• 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. 
• 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.
Diarrhoea can be potentially life-threatening if accompanied by dehydration, renal insufficiency, neutropenia and/or electrolyte imbalances and fatal cases have been reported. 
Driska je lahko smrtno nevarna, če jo spremljajo dehidracija, insuficienca ledvic, nevtropenija in/ali neravnovesje elektrolitov; opisani so bili primeri s smrtnim izidom.
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. 
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.
A summary of efficacy endpoints and overall survival data is provided in Table 4. 
Povzetek opazovanih dogodkov učinkovitosti in podatkov o celokupnem preživetju je prikazan v preglednici 4.
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. 
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.
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). 
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).
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. 
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.
• unusual wheezing, or difficulty in breathing 
• neobičajno sopenje ali težko dihanje,
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). 
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).
At ≥60 mg/kg/day there were decreased foetal body weights, and minor skeletal variations. 
Pri odmerkih ≥ 60 mg/kg/dan so poročali o zmanjšani telesni masi plodov in manjših skeletnih odstopanjih.
Data have shown that Tyverb combined with chemotherapy is less effective than trastuzumab when combined with chemotherapy. 
Podatki so pokazali, da je zdravilo Tyverb v kombinaciji s kemoterapijo manj učinkovito kot trastuzumab v kombinaciji s kemoterapijo.
Dose delay and dose reduction 
Odložitev zdravljenja in zmanjšanje odmerka
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. 
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.
Pre-treatment with a proton pump inhibitor (esomeprazole) decreased lapatinib exposure by an average of 27% (range: 6% to 49%). 
Predhodno zdravljenje z inhibitorjem protonske črpalke (esomeprazol) zmanjša izpostavljenost lapatinibu za povprečno 27 % (od 6 % do 49 %).
Your doctor will decide on the correct dose of Tyverb depending on the type of breast cancer being treated. 
Zdravnik bo določil za vas pravi odmerek zdravila Tyverb glede na vrsto zdravljenega raka dojke.
• If you are pregnant or planning to become pregnant, tell your doctor. 
• Če ste noseči ali nameravate zanositi, to povejte svojemu zdravniku.
Lapatinib has not been evaluated in patients with symptomatic cardiac failure. 
Lapatiniba niso ocenjevali pri bolnikih s simptomatskim srčnim popuščanjem.
Diarrhoea generally occurs early during Tyverb treatment, with almost half of those patients with diarrhoea first experiencing it within 6 days. 
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.
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. 
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.
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. 
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.
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). 
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).
Your doctor will advise you about the dose of your other anti-cancer medicine, and how to take it. 
Zdravnik vam bo povedal tudi za odmerek drugega zdravila proti raku in kako morate jemati to drugo zdravilo.
- 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). 
- 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).
Bottles 3 years 
Plastenke 3 leta
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). 
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).
Patients should be instructed to promptly report any change in bowel patterns. 
Bolnikom je treba naročiti, naj takoj sporočijo kakršnekoli spremembe v ritmu odvajanja.
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. 
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.
Investigator analysis on data at the end of enrolment is presented in Table 1. 
Analiza podatkov, ki so jo naredili raziskovalci, je predstavljena v tabeli 1.
Tyverb has no influence on the ability to drive and use machines. 
Zdravilo Tyverb nima vpliva na sposobnost vožnje in upravljanja strojev.
What Tyverb is and what it is used for What you need to know before you take Tyverb How to take Tyverb 
Kaj je zdravilo Tyverb in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Tyverb Kako jemati zdravilo Tyverb Možni neželeni učinki
Component of a multipack, cannot to be sold separately. 
Sestavni deli pakiranja po več enot ne smejo biti v prometu kot samostojna enota.
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. 
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.
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. 
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.
If you forget to take Tyverb 
Če ste pozabili vzeti zdravilo Tyverb
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. 
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.
• topotecan, paclitaxel, irinotecan, docetaxel - medicines used to treat certain types of cancer 
• topotekan, paklitaksel, irinotekan, docetaksel - zdravila za zdravljenje nekaterih vrst raka,
Grapefruit juice may inhibit CYP3A4 in the gut wall and increase the bioavailability of lapatinib and should therefore be avoided during treatment with Tyverb. 
Sok grenivke lahko zavre CYP3A4 v črevesni steni in poveča biološko uporabnost lapatiniba, zato se mu je med zdravljenjem z zdravilom Tyverb treba izogibati.
Randomisation was stratified by prior trastuzumab treatment and number of prior treatments for metastatic disease. 
Randomizacija je bila stratificirana po predhodnem zdravljenju s trastuzumabom in številom predhodnih zdravljenj zaradi metastatske bolezni.
However, daily dosing of lapatinib results in achievement of steady state within 6 to 7 days, indicating an effective half-life of 24 hours. 
Pri dnevnem odmerjanju lapatiniba je stanje dinamičnega ravnovesja doseženo v 6 do 7 dneh, kar kaže efektivni razpolovni čas 24 ur.
Lapatinib is highly bound (greater than 99%) to albumin and alpha-1 acid glycoprotein. 
Lapatinib se v velikem obsegu (več kot 99 %) veže na albumin in alfa-1 kisli glikoprotein.
You are responsible to decide if you are able to drive a motor vehicle or perform other tasks that require increased concentration. 
O svojih sposobnostih za vožnjo motornih vozil ali opravljanje opravil, ki zahtevajo zbranost, morate presoditi sami.
Subgroup analysis results based on predefined stratification factor (hormone receptor status) is also shown in Table 5. 
Preglednica 5 prikazuje tudi analizo rezultatov podskupin po vnaprej opredeljenem stratifikacijskem dejavniku (stanje hormonskih receptorjev).
The most common adverse reactions (>25%) during therapy with lapatinib were gastrointestinal events (such as diarrhoea, nausea, and vomiting) and rash. 
Najpogostejši neželeni učinki (> 25 %) med zdravljenjem z lapatinibom so bili gastrointestinalni učinki (npr. driska, navzea in bruhanje) in izpuščaj.
Effects of lapatinib on other medicinal products 
Vpliv lapatiniba na druga zdravila
Lapatinib alone (N=148 ) 
Lapatinib sam (N=148)
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). 
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).
Diarrhoea responds well to proactive management (see section 4.4). 
Driska se je dobro odzvala na proaktivno zdravljenje (glejte poglavje 4.4).
Ventricular arrhythmias/Torsades de Pointes, electrocardiogram QT prolonged** 
Pogostnost neznana ventrikularne aritmije/torsades de pointes, podaljšanje intervala QT na elektrokardiogramu**
In a single case of a patient who took 9000 mg of Tyverb, sinus tachycardia (with otherwise normal ECG) was also observed. 
Pri enem samem bolniku, ki je vzel 9.000 mg zdravila Tyverb, so zabeležili tudi sinusno tahikardijo (s sicer normalnim EKG).
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. 
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.
The patients in the registration study were not previously treated with trastuzumab or an aromatase inhibitor (see sections 4.4. and 5.1). 
Bolnice v registracijski študiji predhodno niso bile zdravljene s trastuzumabom ali zaviralcem aromataze (glejte poglavji 4.4 in 5.1).
Observed adverse reactions included dyspnoea, cardiac failure and palpitations. 
Opaženi neželeni učinki so vključevali dispnejo, srčno popuščanje in palpitacije.
In studies across the clinical development programme for lapatinib, cardiac events including LVEF decreases were reported in approximately 1% of patients. 
V študijah, izvedenih v programu kliničnega razvoja lapatiniba, so bili dogodki na srcu (vključno z zmanjšanjem LVEF) opisani pri približno 1 % bolnikov.
Proactive management of diarrhoea with anti-diarrhoeal medicinal product is important. 
Pomembno je proaktivno zdravljenje driske z antidiaroiki.
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. 
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.
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%. 
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 %.
Progression-free survival (PFS) was the primary endpoint of the study with response rate and overall survival (OS) as secondary endpoints. 
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.
OUTER CARTON (14 DAY PACK, PART OF 28 DAY MULTIPACK without blue box) 
ŠKATLA (PAKIRANJE ZA 14-DNEVNO ZDRAVLJENJE, SESTAVNI DEL PAKIRANJA PO VEČ ENOT ZA 28-DNEVNO ZDRAVLJENJE brez modrega okenca)
Each film-coated tablet contains lapatinib ditosylate monohydrate, equivalent to 250 mg lapatinib. 
Ena filmsko obložena tableta vsebuje lapatinibijev ditosilat monohidrat, kar ustreza 250 mg lapatiniba.
• Take Tyverb either at least one hour before or at least one hour after food. 
• Zdravilo Tyverb vzemite vsaj eno uro pred ali vsaj eno uro po obroku ali prigrizku.
Your doctor will check your skin before and during treatment. 
Zdravnik vam bo pred zdravljenjem in med zdravljenjem preverjal stanje kože.
Tyverb is indicated for the treatment of adult patients with breast cancer, whose tumours overexpress HER2 (ErbB2); 
Zdravilo Tyverb je indicirano za zdravljenje odraslih bolnikov z rakom dojke s prekomerno izraženimi HER2 (ErbB2):
The relevance of these findings for humans is uncertain. 
Pomen teh izsledkov za človeka ni gotov.
Measurements, including electrocardiograms (ECGs) and pharmacokinetic samples, were taken at baseline and at the same time points on Day 2 and Day 4. 
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.
The safe use of Tyverb during breast-feeding has not been established. 
Varnost uporabe zdravila Tyverb med dojenjem ni bila dokazana.
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. 
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 %.
Blister packs 2 years 
Pretisni omoti 2 leti
Lapatinib was studied in pregnant rats and rabbits given oral doses of 30, 60, and 120 mg/kg/day. 
Lapatinib so raziskovali pri brejih podganah in kunčicah, ki so ga prejemale peroralno v odmerkih 30, 60 in 120 mg/kg/dan.
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). 
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).
• Depending on the side effects you experience, your doctor may recommend lowering your dose or temporarily stopping your treatment. 
• Zdravnik vam lahko glede na neželene učinke, ki se vam pojavijo, predpiše manjši odmerek ali pa zdravljenje začasno prekine.
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). 
Varnost lapatiniba so vrednotili tako pri samostojnem zdravljenju kot pri uporabi v kombinaciji z drugimi kemoterapevtiki pri različnih vrstah raka pri več kot 20.000 bolnikih, vključno z 198 bolniki, ki so prejemali lapatinib skupaj s kapecitabinom, 149 bolniki, ki so prejemali lapatinib v kombinaciji s trastuzumabom in 654 bolniki, ki so prejemali lapatinib skupaj z letrozolom (glejte poglavje 5.1).
(95% CI), p-value b 
(95 % IZ), vrednost p b
The effect of Tyverb during pregnancy is not known. 
Vpliv zdravila Tyverb na nosečnost ni znan.
There are no adequate data from the use of Tyverb in pregnant women. 
Ni zadostnih podatkov o uporabi zdravila Tyverb pri nosečnicah.
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. 
Poleg tega so morali raziskovalci, po protokolu, pri bolnicah ugotoviti napredovanje med uporabo zadnje sheme s trastuzumabom pri zdravljenju bolezni z metastazami.
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). 
Zdravilo Tyverb uporabljamo za zdravljenje nekaterih vrst raka dojke (s čezmerno ekspresijo HER2), ki se je razširil zunaj prvotnega tumorja ali na druge organe (napredovali ali metastatski rak dojke).
Hepatotoxicity has occurred with Tyverb use and may in rare cases be fatal. 
Pri uporabi zdravila Tyverb so poročali o pojavu hepatotoksičnosti, ki je v redkih primerih lahko usodna.
Co-administration of Tyverb with irinotecan (when administered as part of the FOLFIRI regimen) resulted in an approximate 40% increase in the AUC of SN-38, the active metabolite of irinotecan. 
Sočasna uporaba zdravila Tyverb z irinotekanom (uporabljenim kot del sheme FOLFIRI) je za približno 40 % povečala AUC SN-38, aktivnega presnovka irinotekana.
An additional 75 patients were enrolled in the study between the time of the interim analysis and the end of the enrolment. 
Med časom vmesne analize in koncem vključevanja je bilo v študijo vključenih še nadaljnjih 75 bolnikov.
8.9 mos (6.7, 11.8) 
8,9 meseca (6,7; 11,8)
In rats, the incidence of benign haemangioma of the mesenteric lymph nodes was higher in some groups than in concurrent controls. 
Pri podganah je bila incidenca benignih hemangiomov mezenteričnih bezgavk v nekaterih skupinah večja kot pri sočasni kontrolni skupini.
• in combination with an aromatase inhibitor for postmenopausal women with hormone receptor positive metastatic disease, not currently intended for chemotherapy. 
• v kombinaciji z zaviralcem aromataze pri postmenopavzalnih ženskah z metastatsko boleznijo, pozitivno glede hormonskih receptorjev, ki trenutno niso namenjene za kemoterapijo.
8.2 wks (7.4, 9.3) 
8,2 tedna (7,4; 9,3)
• verapamil - a medicine used to treat high blood pressure or heart problems (angina) 
• verapamil - zdravilo za zdravljenje visokega krvnega tlaka ali težav s srcem (angine pektoris),
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. 
a. Ocena razmerja ogroženosti zdravljenja, pri čemer < 1 pomeni manjše tveganje z letrozolom 2,5 mg + lapatinibom 1500 mg v primerjavi z letrozolom 2,5 mg + placebom.
There are limited data on the use of Tyverb / capecitabine and Tyverb / trastuzumab in patients aged ≥ 65 years. 
Podatkov o uporabi kombinacij Tyverb/kapecitabin in Tyverb/trastuzumab pri bolnikih, starih ≥ 65 let, je malo.
The risk of lapatinib-induced hepatotoxicity was associated with carriage of the HLA alleles DQA1*02:01 and DRB1*07:01 (see section 4.4). 
Tveganje za hepatotoksičnost, povzročeno z lapatinibom, je povezano s prisotnostjo HLA-alelov DQA1*02:01 in DRB1*07:01 (glejte poglavje 4.4).
To minimise variability in the individual patient, administration of Tyverb should be standardised in relation to food intake, for example always to be taken one hour before a meal (see sections 4.5 and 5.2 for information on absorption). 
Zaradi zmanjšanja variabilnosti pri posameznem bolniku je treba jemanje zdravila Tyverb standardizirati glede na obrok hrane, na primer tako, da ga bolnik vedno jemlje pred obrokom (za podatke o absorpciji glejte poglavji 4.5 in 5.2).