natgillin/translations-raw huggingface dataset:
Table 7 Overall survival (OS) results from study EGF30008 (in the HER2-positive population only)
Preglednica 7 Rezultati celokupnega preživetja (OS - overall survival) v študiji EGF30008 (samo v HER2-pozitivni populaciji)
• if you have diarrhoea (see section 4).
• če imate drisko (glejte poglavje 4).
• swollen eyelids, lips or tongue
• oteklino očesnih vek, ustnic ali jezika,
17.2 mos (13.9, 19.2)
17,2 meseca (13,9; 19,2)
Lapatinib plus trastuzumab (N=148)
Lapatinib + trastuzumab (N=148)
Contact a doctor or pharmacist immediately.
Nemudoma se posvetujte z zdravnikom ali s farmacevtom.
At the time of the final PFS analysis (with median follow-up of 2.64 years), the overall survival data were not mature and there was no significant difference between treatment groups in the HER2-positive population; this had not changed with additional follow-up (>7.5 years median followup time; Table 7).
Ob času končne analize preživetja brez napredovanja (z medianim časom spremljanja 2,64 leta) podatki o celokupnem preživetju niso bili dozoreli in med zdravljenimi skupinami v HER2-pozitivni populaciji ni bilo značilne razlike; to se med nadaljnjim spremljanjem (mediani čas spremljanja > 7,5 leta, preglednica 7) ni spremenilo.
There is no specific antidote for the inhibition of EGFR (ErbB1) and/or HER2 (ErbB2) tyrosine phosphorylation.
Specifičnega antidota za zaviranje EGFR (ErbB1) in/ali HER2 (ErbB2) tirozinske fosforilacije ni.
HER2 (ErbB2) overexpressing tumours are defined by IHC3+, or IHC2+ with gene amplification or gene amplification alone.
Tumorji s prekomerno ekspresijo HER2 (ErbB2) so opredeljeni z IHC3+ ali IHC2+ in amplifikacijo gena ali amplifikacijo gena samo.
The effect on human fertility is unknown.
Vpliv na plodnost pri človeku ni znan.
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).
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).
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
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
Tell your doctor or pharmacist if you notice any side effects not listed in this leaflet.
Obvestite svojega zdravnika ali farmacevta, če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu.
• avoid herbal supplements (some may cause diarrhoea).
• izogibajte se zeliščnim dodatkom (nekateri od njih lahko povzročijo drisko).
b. P-value from Cox regression model, stratifying for site of disease and prior anti-adjuvant therapy at screening.
b. Vrednost p iz Coxovega regresijskega modela, stratificirano za mesto bolezni in predhodno anti-adjuvantno zdravljenje ob presejanju.
Peak plasma concentrations (Cmax) of lapatinib are achieved approximately 4 hours after administration.
Najvišje plazemske koncentracije (Cmax) lapatiniba so dosežene približno 4 ure po uporabi.
What you need to know before you take Tyverb
Kaj morate vedeti, preden boste vzeli zdravilo Tyverb
A detrimental effect on such activities cannot be predicted from the pharmacology of lapatinib.
Škodljivega vpliva na tovrstne aktivnosti iz farmakologije lapatiniba ni mogoče predvideti.
• irregular heart-beat (change in the electrical activity of the heart)
• neenakomeren srčni utrip (sprememba v električni aktivnosti srca),
There is more advice on reducing the risk of skin rash at the end of section 4.
Več nasvetov o zmanjšanju tveganja izpuščaja na koži je na koncu poglavja 4.
PFS event is Progressed or Died and OS event is Died due to any cause.
Dogodek PFS je "napredovanje" ali "smrt", dogodek OS pa "smrt zaradi kakršnega koli vzroka".
Prescribing physicians are advised to perform a skin examination prior to treatment and regularly during treatment.
Zdravniki, ki predpisujejo to zdravilo, morajo pregled kože opraviti pred zdravljenjem in ga izvajati redno med zdravljenjem.
However, a few cases of acute renal failure have been reported secondary to severe dehydration due to diarrhoea.
Vendar je bilo opisanih nekaj primerov akutne odpovedi ledvic po hudi dehidraciji zaradi driske.
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.