natgillin/translations-raw huggingface dataset:
Tell your doctor or pharmacist immediately if you become pregnant during treatment with Vargatef. 
Zdravniku ali farmacevtu takoj povejte, če boste med zdravljenjem z zdravilom Vargatef zanosili.
In vitro, CYP-dependent metabolism accounted for about 5 % compared to about 25 % ester cleavage. 
Delež od CYP odvisne presnove in vitro je približno 5 % v primerjavi s približno 25 % cepitve estra.
Based on the high inter-individual variability of exposure observed in the clinical LUME-Lung-1 trial these effects are not considered clinically relevant. 
Na podlagi velike variabilnosti izpostavljenosti med posamezniki, ki so jo opazili v kliničnem preskušanju LUME-Lung-1, našteti učinki ne veljajo za klinično pomembne.
In case of further persistence of the adverse reaction(s), i.e. if a patient does not tolerate 100 mg twice daily, treatment with Vargatef should be permanently discontinued. 
Kadar neželeni učinek/ učinki ne izginejo, tj. če bolnik ne prenaša odmerka po 100 mg dvakrat na dan, je treba zdravljenje z zdravilom Vargatef trajno ukiniti.
In patients on chronic low dose therapy with low molecular weight heparins or acetylsalicylic acid, no increased frequency of bleeding was observed. 
Pri bolnikih s stalnim zdravljenjem z majhnjimi odmerki nizkomolekularnih heparinov ali acetilsalicilno kislino niso opazili večje pogostnosti krvavitev.
Black ink: 
Črnilo:
Diarrhoea ≥ grade 3 despite anti-diarrhoeal treatment 
Navzea ≥ 3. stopnje kljub zdravljenju z antiemetiki
The population mean exposure to nintedanib was 33 - 50 % higher in Chinese, Taiwanese, and Indian patients and 16 % higher in Japanese patients while it was 16 - 22 % lower in Koreans compared to Caucasians (body weight corrected). 
Populacijska srednja izpostavljenost nintedanibu je bila od 33 % do 50 % večja pri Kitajcih, Tajvancih in Indijcih ter 16 % večja pri Japoncih, medtem ko je pri Korejcih od 16 % do 22 % manjša v primerjavi z belci (popravljena glede na telesno maso).
If you take more Vargatef than you should Contact your doctor or pharmacist immediately. 
Če ste vzeli večji odmerek zdravila Vargatef, kot bi smeli Takoj se posvetujte z zdravnikom ali farmacevtom.
However, no thorough QT-trial of nintedanib administered in combination with docetaxel was conducted. 
Vendar temeljitih preskušanj QT z nintedanibom v kombinaciji z docetakselom niso izvajali.
A pre-specified evaluation was performed in the population of adenocarcinoma patients considered to have entered the trial with a particularly poor treatment prognosis, namely, patients who progressed during or shortly after first-line therapy prior to trial entry. 
Izvedli so vnaprej opredeljeno analizo populacije bolnikov z adenokarcinomom, ki so imeli ob vstopu v preskušanje izjemno slabo prognozo zdravljenja, in sicer pri tistih, pri katerih se je napredovanje bolezni pojavilo med zdravljenjem prve izbire ali kmalu zatem, torej pred vstopom v preskušanje.
It is for adult patients whose NSCLC is of a certain type (“adenocarcinoma”) and who had already received one treatment with another medicine to treat this cancer but whose tumour started to grow again. 
Namenjeno je odraslim bolnikom, ki imajo določeno vrsto nedrobnoceličnega pljučnega raka (adenokarcinom) in so se predhodno že zdravili z drugim zdravilom proti raku, a je začel tumor ponovno rasti.
What you need to know before you take Vargatef 
Kaj morate vedeti, preden boste vzeli zdravilo Vargatef
The individual daily doses of nintedanib should not be increased beyond the recommended dose to make up for missed doses. 
Posameznih dnevnih priporočenih odmerkov nintedaniba ni dovoljeno povečati, zato da bi nadomestili pozabljene odmerke.
Women of childbearing potential being treated with Vargatef should be advised to avoid becoming pregnant while receiving this treatment and to use adequate contraception during and at least 3 months after the last dose of Vargatef. 
Ženskam v rodni dobi, ki se zdravijo z zdravilom Vargatef, je treba svetovati, naj med zdravljenjem s tem zdravilom ne zanosijo in naj uporabljajo ustrezno kontracepcijo med njegovim jemanjem in še vsaj 3 mesece po zadnjem odmerku.
Based on preclinical investigations there is no evidence for impairment of male fertility (see section 5.3). 
Na podlagi predkliničnih preiskav ni znakov za vpliv na plodnost pri moških (glejte poglavje 5.3).
However, the frequency of patients with gastrointestinal perforation was low. 
Vendar je bila pogostnost bolnikov s predrtjem prebavil majhna.
Do not take Vargatef on the same day as your chemotherapy treatment with docetaxel. 
Zdravila Vargatef ne vzemite istega dne, ko prejmete kemoterapijo z docetakselom.
Do not take Vargatef - if you are allergic to nintedanib, to peanut or soya, or to any of the other ingredients of this medicine (listed in section 6). 
Ne jemljite zdravila Vargatef - če ste alergični na nintedanib, arašide ali sojo, ali na katerokoli sestavino tega zdravila (navedeno v poglavju 6).
A study of male fertility and early embryonic development to implantation in rats did not reveal effects on the male reproductive tract and male fertility. 
Študija vpliva na sposobnost razmnoževanja pri samcih in zgodnjega razvoja zarodka do implantacije pri podganah ni razkrila učinkov na reproduktivni sistem niti na sposobnost razmnoževanja pri samcih.
As initial measure for the management of adverse reactions (see Tables 1 and 2) treatment with nintedanib should be temporarily interrupted until the specific adverse reaction has resolved to levels that allow continuation of therapy (to grade 1 or baseline). 
Začetni ukrep za obravnavo neželenih učinkov (glejte Preglednico 1 in 2) je začasna prekinitev zdravljenja z nintedanibom, dokler specifični neželeni učinek ne bo izzvenel do ravni, ki omogoča nadaljevanje zdravljenja (do 1. stopnje ali izhodiščnega stanja).
No correlation of the DCE-MRI response and subsequent clinically significant reduction in target lesion size was found, but DCE-MRI response was associated with disease stabilization. 
Korelacije odziva na DCE-MRI z naknadnimi klinično značilno zmanjšanimi velikostmi ciljnih lezij niso ugotovili, vendar je bil tovrsten odziv povezan s stabilizacijo bolezni.
As several other tyrosine kinase inhibitors are known to exert an effect on QT, caution should be exercised when administering nintedanib in patients who may develop QTc prolongation. 
Znano je, da nekateri drugi zaviralci tirozin kinaze vplivajo na interval QT, zato je pri dajanju nintedaniba bolnikom, pri katerih lahko pride do podaljšanja intervala QTc, potrebna previdnost.
Diarrhoea (very common, may affect more than 1 in 10 people) Diarrhoea may lead to a loss of fluid and important salts (electrolytes, such as sodium or potassium) in your body. 
driska (zelo pogosta, pojavi se lahko pri več kot 1 od 10 bolnikov) Driska lahko povzroči izgubo tekočine in pomembnih soli (elektrolitov, kot sta natrij in kalij) v telesu.
The rates of sepsis (1.3 %) and febrile neutropenia (7.5 %) were increased under treatment with nintedanib as compared to the placebo arm. 
Deleža sepse (1,3 %) in febrilne nevtropenije (7,5 %) sta bila pri zdravljenju z nintedanibom povečana v primerjavi s skupino s placebom.
Dose reduction 
Zmanjševanje odmerka
Diarrhoea occurred in 43.4 % (≥ grade 3: 6.3 %) of adenocarcinoma patients in the nintedanib arm. 
Driska se je pojavila pri 43,4 % (≥ 3. stopnje: 6,3 %) bolnikov z adenokarcinomom v skupini z nintedanibom.
Therefore, it is not recommended to treat these patients with Vargatef. 
Zato zdravljenje teh bolnikov z zdravilom Vargatef ni priporočljivo.
Vargatef contains soya The capsules contain soya lecithin. 
Zdravilo Vargatef vsebuje sojo Kapsule vsebujejo sojin lecitin.
In repeat dose toxicology studies in rats, adverse effects (e.g. thickening of epiphyseal plates, lesions of the incisors) were mostly related to the mechanism of action (i.e. VEGFR-2 inhibition) of nintedanib. 
V študijah toksičnosti po ponavljajočih se odmerkih pri podga nah so bili neželeni učinki (npr. odebelitev epifiznih ploščic, lezije sekalcev) večinoma povezani z mehanizmom delovanja (z zaviranjem VEGFR-2) nintedaniba.
Exposure increased in patients with hepatic impairment (Child Pugh A, Child Pugh B; see section 5.2). 
Izpostavljenost se je povečala pri bolnikih z jetrno okvaro (Child Pugh A, Child Pugh B; glejte poglavje 5.2).
Blood counts should be monitored during therapy, in particular during the combination treatment with docetaxel. 
Med zdravljenjem je treba spremljati krvno sliko, zlasti med kombiniranim zdravljenjem z docetakselom.
In the pivotal trial 1199.13, 85 patients (12.9 % of the patients with adenocarcinoma histology) were ≥ 70 years of age (median age: 72 years, range: 70 - 80 years) (see section 5.1). 
V ključnem preskušanju 1199.13 je bilo 85 bolnikov (12,9 % je imelo histologijo adenokarcinoma) starih ≥ 70 let (mediana starost: 72 let, razpon: 70 do 80 let) (glejte poglavje 5.1).
Patients with a recent history of myocardial infarction or stroke were excluded from this trial. 
Bolniki z miokardnim infarktom ali možgansko kapjo v nedavni anamnezi so bili iz tega preskušanja izključeni.
No adjustment of the initial dosing is required on the basis of a patient's age (see section 5.2). 
Začetnega odmerka ni treba prilagajati bolnikovi starosti (glejte poglavje 5.2).
Treatment with Vargatef should therefore only be initiated or - in case of perioperative interruption - resumed based on clinical judgement of adequate wound healing. 
Zdravilo Vargatef je zato dovoljeno uvesti (ali v primeru perioperativne prekinitve, nadaljevati njegovo jemanje) le na podlagi klinične ocene ustreznega celjenja ran.
Of note, pre-planned analyses according to histology showed statistically significant difference in OS between treatment arms in the adenocarcinoma population only (Table 4). 
Omembe vredno je, da so predhodno načrtovane analize glede na histologijo pokazale statistično značilno razliko v celokupnem preživetju zdravljenih skupin samo v populaciji bolnikov z adenokarcinomom (Preglednica 4).
Vargatef capsules must be taken orally, preferably with food, swallowed whole with water, and must not be chewed or crushed. 
Način uporabe Kapsule zdravila Vargatef je treba zaužiti cele z vodo, najbolje s hrano; ne sme se jih žvečiti ali drobiti.
It is important that the patient's blood counts are monitored during therapy, in particular during the combination treatment with docetaxel (see section 4.4). 
Med zdravljenjem je pomembno spremljati bolnikovo krvno sliko, zlasti med kombiniranim zdravljenjem z docetakselom (glejte poglavje 4.4).
Sepsis and febrile neutropenia have been reported as subsequent complications of neutropenia. 
O sepsi in febrilni nevtropeniji so poročali kot o zapletu, ki je sledil nevtropeniji.
Overall survival analysis in the overall population did not reach statistical significance (HR 0.94; 95 % CI: 0.83 - 1.05). 
Analiza celokupnega preživetja v celotni populaciji bolnikov ni dosegla statistične pomembnosti (RO: 0,94; 95 % IZ: 0,83; 1,05).
The efficacy and safety of Vargatef was investigated in 1314 adult patients with locally advanced, metastatic or recurrent NSCLC after one prior line of chemotherapy. 
Učinkovitost in varnost zdravila Vargatef so proučevali pri 1.314 odraslih bolnikih z lokalno napredovalim, metastatskim ali ponovljenim NSCLC po eni predhodni kemoterapiji.
Table 3 summarizes the frequencies of adverse drug reactions that were reported in the pivotal trial LUME-Lung 1 for patients with NSCLC of adenocarcinoma tumour histology (n = 320) or from the post-marketing period. 
Preglednica 3 prikazuje povzetek pogostnosti neželenih učinkov, o katerih so poročali v ključnem preskušanju LUME-Lung 1 za bolnike z NSCLC s histologijo adenokarcinoma (n = 320) ali iz obdobja trženja.
Myocardial infarction (see section 4.4) 
Srčne bolezni miokardni infarkt (glejte poglavje 4.4)
The values should be monitored as clinically indicated or periodically during treatment, i.e. in the combination phase with docetaxel at the beginning of each treatment cycle and monthly in case Vargatef is continued as monotherapy after discontinuation of docetaxel. 
Vrednosti je treba med zdravljenjem spremljati, kot je klinično indicirano ali periodično, to je v obdobju dajanja v kombinaciji z docetakselom na začetku vsakega terapevtskega cikla in nato mesečno, če bolniki jemanje zdravila Vargatef po ukinitvi docetaksela nadaljujejo kot monoterapijo.
In case your doctor has stopped your chemotherapy with docetaxel you should continue to take Vargatef twice daily. 
Če vas je zdravnik prenehal zdraviti s kemoterapijo z docetakselom, morate nadaljevati jemanje zdravila Vargatef 2-krat na dan.
This medicine is used in combination with another cancer medicine (docetaxel) to treat a cancer of the lung called non-small cell lung cancer (NSCLC). 
To zdravilo se uporablja v kombinaciji z drugim zdravilom za zdravljenje raka (docetaksel), ki se uporablja za zdravljenje vrste pljučnega raka imenovanega nedrobnocelični pljučni rak (non-small cell lung cancer - NSCLC).
Your doctor may reduce your recommended dose to 300 mg per day (two capsules of 150 mg). 
Zdravnik lahko vaš priporočeni odmerek zmanjša na 300 mg na dan (dve kapsuli po 150 mg).
- if you have high blood pressure - if you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall 
- če imate visok krvni tlak; - če imate ali ste imeli anevrizmo (razširitev in oslabitev stene krvne žile) ali raztrganino v steni krvne žile.
Hypersensitivity to nintedanib, to peanut or soya, or to any of the excipients listed in section 6.1. 
Preobčutljivost za nintedanib, arašide ali sojo ali katero koli pomožno snov, navedeno v poglavju 6.1.
Nintedanib binds competitively to the adenosine triphosphate (ATP) binding pocket of these receptors and blocks the intracellular signalling which is crucial for the proliferation and survival of endothelial as well as perivascular cells (pericytes and vascular smooth muscle cells). 
Nintedanib se kompetitivno veže na vezavno mesto adenozin trifosfata (ATP) teh receptorjev in zavira znotrajcelično signaliziranje, ki je odločilno za proliferacijo in preživetje endotelijskih in perivaskularnih celic (periciti in žilne gladkomišične celice).
Tumour angiogenesis is an essential feature contributing to tumour growth, progression and metastasis formation and is predominantly triggered by the release of pro-angiogenic factors secreted by the tumour cell (i.e. VEGF and bFGF) to attract host endothelial as well as perivascular cells to facilitate oxygen and nutrient supply through the host vascular system. 
Angiogeneza tumorja je bistvena lastnost, ki prispeva k njegovi rasti, napredovanju in nastajanju metastaz, in jo pretežno sproža sproščanje proangiogenskih dejavnikov, ki jih izločajo tumorske celice (VEGF in bFGF), ki privlačijo gostiteljske endotelijske in perivaskularne celice in tako olajšajo oskrbo s kisikom in hranili prek gostiteljskega žilnega sistema.
It is recommended to take the capsule with food, i.e. during or immediately before or after a meal. 
Kapsule je priporočljivo jemati s hrano, torej med obrokom, tik pred njim ali takoj po njem.
In a post-hoc analysis in adenocarcinoma patients having progressed and entered the trial ≥ 9 months since start of their first-line therapy the difference did not reach statistical significance (HR for OS: 0.89, 95 % CI 0.66 - 1.19). 
V post-hoc analizi pri bolnikih z napredovalim adenokarcinomom, ki so v preskušanje vstopili ≥ 9 mesecev od začetka zdravljenja v prvi liniji, razlika ni dosegla statistične pomembnosti (RO za CP: 0,89, 95 % IZ 0,66-1,19).
Nintedanib is a triple angiokinase inhibitor blocking vascular endothelial growth factor receptors (VEGFR 1-3), platelet-derived growth factor receptors (PDGFR α and ß) and fibroblast growth factor receptors (FGFR 1-3) kinase activity. 
Nintedanib je trojni zaviralec angiokinaze, ki zavira aktivnost kinaze receptorjev žilnega endotelijskega rastnega faktorja (vascular endothelial growth factor receptors - VEGFR 1-3), receptorje rastnega faktorja iz trombocitov (platelet-derived growth factor receptors - PDGFR α in ß) in receptorjev rastnega faktorja fibroblastov (fibroblast growth factor receptors - FGFR 1-3).
Exposure to nintedanib was not influenced by gender (body weight corrected), mild and moderate renal impairment (estimated by creatinine clearance), liver metastases, ECOG performance score, alcohol consumption, and P-gp genotype. 
Na izpostavljenost nintedanibu niso vplivali spol (prilagojen za telesno maso), blaga ali zmerna ledvična okvara (ocenjeno z očistkom kreatinina), metastaze v jetrih, rezultat zmogljivosti po ECOG, pitje alkohola in genotip P-gp.
However, based on the mechanism of action patients treated with Vargatef may have an increased risk of gastrointestinal perforations. 
Vendar zaradi mehanizma delovanja pri bolnikih, zdravljenih z zdravilom Vargatef, lahko obstaja povečano tveganje za predrtje prebavil.
Pregnancy testing should be conducted at least prior to treatment with Vargatef. 
Testiranje nosečnosti je treba opraviti že pred zdravljenjem z zdravilom Vargatef.
Febrile neutropenia and sepsis (common, may affect up to 1 in 10 people) Treatment with Vargatef may lead to a reduced number of a type of your white blood cells (neutropenia) which are important for the body´s reaction against bacterial or fungal infections. 
febrilna nevtropenija in sepsa (pogosti, pojavita se lahko pri največ 1 od 10 bolnikov) Zdravljenje z zdravilom Vargatef lahko zmanjša število vrste belih krvnih celic (nevtropenija), ki so pomembne za odziv telesa proti bakterijskim ali glivičnim okužbam.
If necessary, your doctor may further reduce your daily dose to 200 mg per day (two capsules of 100 mg). 
Če je potrebno, vam lahko zdravnik vaš dnevni odmerek znova zmanjša na 200 mg na dan (dve kapsuli po 100 mg).
Vargatef 100 mg soft capsules EU/1/14/954/001 
Vargatef 100 mg mehke kapsule EU/1/14/954/001
Vargatef is indicated in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy. 
Zdravilo Vargatef je indicirano v kombinaciji z docetakselom za zdravljenje odraslih bolnikov z lokalno napredovalim, metastatskim ali lokalno ponovljivim nedrobnoceličnim pljučnim rakom (non-small cell lung cancer - NSCLC) s histologijo adenokarcinoma po kemoterapiji prve izbire.
Particular caution should be exercised when treating patients with previous abdominal surgery or a recent history of a hollow organ perforation. 
Posebno pozornost zahteva zdravljenje bolnikov, ki so imeli predhodno abdominalno operacijo ali imajo v nedavni anamnezi predrtje votlega organa.
Based on population pharmacokinetic (PK) analyses, no a priori dose adjustments of Vargatef are necessary (see section 5.2). 
Na podlagi populacijskih farmakokinetičnih (FK) analiz odmerka zdravila Vargatef ni treba vnaprej prilagajati (glejte poglavje 5.2).
The HR for these patients for PFS and OS was 1.24 (95 % CI: 0.68, 2.28) and 1.09 (95 % CI: 0.70, 1.70), respectively. 
RO za te bolnike za PFS je bil 1,24 (95 % IZ: 0,68, 2,28), za celokupno preživetje pa 1,09 (95 % IZ: 0,70, 1,70).
Other information on drug-drug interactions 
Drugi podatki o medsebojnem delovanju zdravil
As expected via its mechanism of action perforation might occur in patients treated with nintedanib. 
Kot je zaradi mehanizma delovanja pričakovano, se lahko pri bolnikih, zdravljenih z nintedanibom, predrejo prebavila.
Efficacy results for trial LUME-Lung 1 for patients with adenocarcinoma tumour histology 
Izsledki o učinkovitosti v preskušanju LUME-Lung 1 za bolnike s histologijo adenokarcinoma
Stratified Log-Rank Test p-value* 
Vrednost p iz stratificiranega log-rang testa *
Neutropenia, febrile neutropenia and sepsis 
Nevtropenija, febrilna nevtropenija in sepsa
Drug-induced liver injury 
z zdravilom povzročena poškodba jeter
Inform your doctor immediately while taking this medicine - if you get diarrhoea. 
Zdravnika takoj obvestite, če boste med jemanjem tega zdravila: - dobili drisko.
Treatment with Vargatef should be initiated and supervised by a physician experienced in the use of anticancer therapies. 
Zdravljenje z zdravilom Vargatef mora uvesti in nadzirati zdravnik, ki ima izkušnje z uporabo onkoloških zdravil.
You need to pay special attention if you get the following side effects during treatment with Vargatef: 
Bodite posebno pozorni na pojav naslednjih neželenih učinkov med zdravljenjem z zdravilom Vargatef:
For information about special populations, recommended measures and dosing adjustments in case of liver enzyme and bilirubin elevations, see sections 4.4 and 4.2, respectively. 
Za informacije o priporočenih ukrepih in prilagajanje odmerjanja v primeru zvišanih ravni jetrnih encimov in bilirubina pri posebnih populacijah glejte poglavji 4.4 in 4.2.
Vargatef 150 mg soft capsules EU/1/14/954/004 
Vargatef 150 mg mehke kapsule EU/1/14/954/004
Treatment of patients with moderate (Child Pugh B) and severe (Child Pugh C) hepatic impairment with Vargatef is not recommended (see sections 4.4 and 5.2). 
Zdravljenja bolnikov z zmerno (Child Pugh B) in hudo (Child Pugh C) jetrno okvaro z zdravilom Vargatef ni priporočeno (glejte poglavji 4.4 in 5.2).
Vargatef should be discontinued in patients with life-threatening venous thromboembolic reactions. 
Uporabo zdravila Vargatef je treba ukiniti pri bolnikih z življenje ogrožajočimi venskimi trombemboličnimi reakcijami.
If co-administered with nintedanib, potent P-gp inhibitors (e.g. ketoconazole or erythromycin) may increase exposure to nintedanib. 
Pri sočasnem dajanju z nintedanibom pa lahko močni zaviralci P-gp (npr. ketokonazol ali eritromicin) povečajo izpostavljenost nintedanibu.
In the clinical trial (LUME-Lung 1; see section 5.1) with Vargatef, the frequency of bleeding in both treatment arms was comparable (see section 4.8). 
V kliničnem preskušanju (LUME-Lung 1; glejte poglavje 5.1) zdravila Vargatef je bila pogostnost krvavitve pri obeh zdravljenih skupinah primerljiva
Elevation of AST and/or ALT values to > 5 x ULN 
Povečane vrednosti AST in/ali ALT na > 5 x ULN
In the overall population, 16.0 % of the patients had disease stage < IIIB/IV, 22.4 %, had disease stage IIIB and 61.6 % had disease stage IV. 9.2 % of the patients entered the trial with locally recurrent disease stage as had been evaluated at baseline. 
V celotni populaciji je 16,0 % bolnikov imelo bolezen stopnje < IIIB/IV, 22,4 % bolezen stopnje IIIB in 61,6 % jih je imelo bolezen stopnje IV. 9,2 % bolnikov je vstopilo v preskušanje z lokalno ponovljeno boleznijo na stopnji izhodiščne ocene.
Since the effect of nintedanib on the metabolism and efficacy of contraceptives has not been investigated, barrier methods should be applied as a second form of contraception, to avoid pregnancy. 
Ker učinka nintedaniba na presnovo in učinkovitost kontraceptivov niso proučevali, je treba kot drugo obliko kontracepcije uporabiti še pregradno metodo.
After food intake, nintedanib exposure increased by approximately 20 % compared to administration under fasted conditions (CI: 95.3 - 152.5 %) and absorption was delayed (median tmax fasted: 2.00 hours; fed: 3.98 h). 
Po vnosu hrane se je izpostavljenost nintedanibu povečala za približno 20 % v primerjavi z uporabo na tešče (IZ: 95,3 do 152,5 %), absorpcija pa je bila upočasnjena (mediana tmax na tešče: 2,00 uri; s hrano: 3,98 ure).
Urinary excretion of the unchanged active substance within 48 h was about 0.05 % of the dose (31.5 % gCV) after oral and about 1.4 % of dose (24.2 % gCV) after intravenous administration; the renal clearance was 20 mL/min (32.6 % gCV). 
V 48 urah se je s sečem izločilo približno 0,05 % odmerka nespremenjene zdravilne učinkovine (31,5 % gCV) po peroralnem zaužitju in približno 1,4 % odmerka (24,2 % gCV) po intravenskem vnosu; ledvični očistek je bil 20 ml/min (32,6 % gCV).
Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE31 
Farmakoterapevtska skupina: zdravila proti novotvorbam, zaviralci proteinskih kinaz; oznaka ATC: L01XE31.
Stable brain metastasis 
Stabilne metastaze v možganih