FrancophonIA/ELRC3.0 huggingface dataset:
English: Sepsis and febrile neutropenia have been reported as subsequent complications of neutropenia.
Slovenian: O sepsi in febrilni nevtropeniji so poročali kot o zapletu, ki je sledil nevtropeniji.
English: Overall survival analysis in the overall population did not reach statistical significance (HR 0.94; 95 % CI: 0.83 - 1.05).
Slovenian: Analiza celokupnega preživetja v celotni populaciji bolnikov ni dosegla statistične pomembnosti (RO: 0,94; 95 % IZ: 0,83; 1,05).
English: 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.
Slovenian: Učinkovitost in varnost zdravila Vargatef so proučevali pri 1.314 odraslih bolnikih z lokalno napredovalim, metastatskim ali ponovljenim NSCLC po eni predhodni kemoterapiji.
English: 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.
Slovenian: 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.
English: Myocardial infarction (see section 4.4)
Slovenian: Srčne bolezni miokardni infarkt (glejte poglavje 4.4)
English: 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.
Slovenian: 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.
English: In case your doctor has stopped your chemotherapy with docetaxel you should continue to take Vargatef twice daily.
Slovenian: Če vas je zdravnik prenehal zdraviti s kemoterapijo z docetakselom, morate nadaljevati jemanje zdravila Vargatef 2-krat na dan.
English: 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).
Slovenian: 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).
English: Your doctor may reduce your recommended dose to 300 mg per day (two capsules of 150 mg).
Slovenian: Zdravnik lahko vaš priporočeni odmerek zmanjša na 300 mg na dan (dve kapsuli po 150 mg).
English: - 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
Slovenian: - če imate visok krvni tlak; - če imate ali ste imeli anevrizmo (razširitev in oslabitev stene krvne žile) ali raztrganino v steni krvne žile.
English: Hypersensitivity to nintedanib, to peanut or soya, or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost za nintedanib, arašide ali sojo ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: It is recommended to take the capsule with food, i.e. during or immediately before or after a meal.
Slovenian: Kapsule je priporočljivo jemati s hrano, torej med obrokom, tik pred njim ali takoj po njem.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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).
English: 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.
Slovenian: 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.
English: However, based on the mechanism of action patients treated with Vargatef may have an increased risk of gastrointestinal perforations.
Slovenian: Vendar zaradi mehanizma delovanja pri bolnikih, zdravljenih z zdravilom Vargatef, lahko obstaja povečano tveganje za predrtje prebavil.
English: Pregnancy testing should be conducted at least prior to treatment with Vargatef.
Slovenian: Testiranje nosečnosti je treba opraviti že pred zdravljenjem z zdravilom Vargatef.
English: 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.
Slovenian: 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.
English: If necessary, your doctor may further reduce your daily dose to 200 mg per day (two capsules of 100 mg).
Slovenian: Če je potrebno, vam lahko zdravnik vaš dnevni odmerek znova zmanjša na 200 mg na dan (dve kapsuli po 100 mg).
English: Vargatef 100 mg soft capsules EU/1/14/954/001
Slovenian: Vargatef 100 mg mehke kapsule EU/1/14/954/001
English: 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.
Slovenian: 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.
English: Particular caution should be exercised when treating patients with previous abdominal surgery or a recent history of a hollow organ perforation.
Slovenian: Posebno pozornost zahteva zdravljenje bolnikov, ki so imeli predhodno abdominalno operacijo ali imajo v nedavni anamnezi predrtje votlega organa.
English: Based on population pharmacokinetic (PK) analyses, no a priori dose adjustments of Vargatef are necessary (see section 5.2).
Slovenian: Na podlagi populacijskih farmakokinetičnih (FK) analiz odmerka zdravila Vargatef ni treba vnaprej prilagajati (glejte poglavje 5.2).
English: 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.
Slovenian: 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).
English: Other information on drug-drug interactions
Slovenian: Drugi podatki o medsebojnem delovanju zdravil
English: As expected via its mechanism of action perforation might occur in patients treated with nintedanib.
Slovenian: Kot je zaradi mehanizma delovanja pričakovano, se lahko pri bolnikih, zdravljenih z nintedanibom, predrejo prebavila.
English: Efficacy results for trial LUME-Lung 1 for patients with adenocarcinoma tumour histology
Slovenian: Izsledki o učinkovitosti v preskušanju LUME-Lung 1 za bolnike s histologijo adenokarcinoma
English: Stratified Log-Rank Test p-value*
Slovenian: Vrednost p iz stratificiranega log-rang testa *
English: Neutropenia, febrile neutropenia and sepsis
Slovenian: Nevtropenija, febrilna nevtropenija in sepsa
English: Drug-induced liver injury
Slovenian: z zdravilom povzročena poškodba jeter
English: Inform your doctor immediately while taking this medicine - if you get diarrhoea.
Slovenian: Zdravnika takoj obvestite, če boste med jemanjem tega zdravila: - dobili drisko.
English: Treatment with Vargatef should be initiated and supervised by a physician experienced in the use of anticancer therapies.
Slovenian: Zdravljenje z zdravilom Vargatef mora uvesti in nadzirati zdravnik, ki ima izkušnje z uporabo onkoloških zdravil.
English: You need to pay special attention if you get the following side effects during treatment with Vargatef:
Slovenian: Bodite posebno pozorni na pojav naslednjih neželenih učinkov med zdravljenjem z zdravilom Vargatef:
English: 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.
Slovenian: 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.
English: Vargatef 150 mg soft capsules EU/1/14/954/004
Slovenian: Vargatef 150 mg mehke kapsule EU/1/14/954/004
English: 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).
Slovenian: 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).
English: Vargatef should be discontinued in patients with life-threatening venous thromboembolic reactions.
Slovenian: Uporabo zdravila Vargatef je treba ukiniti pri bolnikih z življenje ogrožajočimi venskimi trombemboličnimi reakcijami.
English: If co-administered with nintedanib, potent P-gp inhibitors (e.g. ketoconazole or erythromycin) may increase exposure to nintedanib.
Slovenian: Pri sočasnem dajanju z nintedanibom pa lahko močni zaviralci P-gp (npr. ketokonazol ali eritromicin) povečajo izpostavljenost nintedanibu.
English: 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).
Slovenian: V kliničnem preskušanju (LUME-Lung 1; glejte poglavje 5.1) zdravila Vargatef je bila pogostnost krvavitve pri obeh zdravljenih skupinah primerljiva
English: Elevation of AST and/or ALT values to > 5 x ULN
Slovenian: Povečane vrednosti AST in/ali ALT na > 5 x ULN
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Ker učinka nintedaniba na presnovo in učinkovitost kontraceptivov niso proučevali, je treba kot drugo obliko kontracepcije uporabiti še pregradno metodo.
English: 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).
Slovenian: 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).
English: 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).
Slovenian: 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).
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE31
Slovenian: Farmakoterapevtska skupina: zdravila proti novotvorbam, zaviralci proteinskih kinaz; oznaka ATC: L01XE31.
English: Stable brain metastasis
Slovenian: Stabilne metastaze v možganih
English: Single arm study to examine whether genetic/genomic markers (alone or combined with clinical covariates) could be used to predict overall survival (OS) in NSCLC patients eligible for treatment with nintedanib.
Slovenian: 2. študijo z eno skupino z namenom ugotoviti, če bi pregled genetskih/genomskih markerjev (izoliranih ali v kombinaciji s kliničnimi sočasnimi spremenljivkami), lahko uporablja za napoved celokupnega preživetja (CP) med bolniki z NSCLC, primernimi za zdravljenje z zdravilom nintedanib.
English: In a dedicated single dose phase I trial and compared to healthy subjects, exposure to nintedanib based on Cmax and AUC was 2.2-fold higher in volunteers with mild hepatic impairment (Child Pugh A; 90 % CI 1.3 - 3.7 for Cmax and 1.2 - 3.8 for AUC, respectively).
Slovenian: V namenskem preskušanju z enojnim odmerkom faze I in v primerjavi z zdravimi osebami, je bila izpostavljenost nintedanibu na podlagi Cmax in AUC 2,2-krat večja pri prostovoljcih z blago jetrno okvaro (Child Pugh A; 90-% IZ 1,3 - 3,7 za Cmax oz. 1,2 - 3,8 za AUC).
English: The safety data provided in the sections below are based on the global, double-blind randomised pivotal phase 3 trial 1199.13 (LUME-Lung 1) comparing treatment with nintedanib plus docetaxel against placebo plus docetaxel in patients with locally advanced, or metastatic, or recurrent NSCLC after first-line chemotherapy and based on data observed during the post-marketing period.
Slovenian: V spodnjih poglavjih navajamo podatke o varnosti, ki temeljijo na globalnem, dvojno slepem randomiziranem ključnem preskušanju 3. faze 1199.13 (LUME-Lung 1), v katerem so primerjali zdravljenje z nintedanibom in docetakselom s placebom in docetakselom pri bolnikih z lokalno napredovalim ali metastatskim ali ponovljivim NSCLC po kemoterapiji prve izbire in na podlagi podatkov, opaženih v obdobju trženja.
English: Nintedanib may cause foetal harm in humans (see section 5.3).
Slovenian: Nintedanib lahko poškoduje človeški plod (glejte poglavje 5.3).
English: If you forget to take Vargatef
Slovenian: Če ste pozabili vzeti zdravilo Vargatef
English: If you cannot tolerate the recommended dose of 400 mg per day because of side effects (see section 4), your doctor may reduce the daily dose of Vargatef.
Slovenian: Če zaradi neželenih učinkov ne prenašate priporočenega odmerka 400 mg zdravila Vargatef na dan (glejte 4. poglavje), lahko zdravnik zmanjša vaš dnevni odmerek.
English: iron oxide yellow (E172)
Slovenian: rumeni železov oksid (E172)
English: Recommended dose adjustments for Vargatef (nintedanib) in case of AST and/or ALT and bilirubin elevations
Slovenian: Prilagajanje priporočenega odmerka za zdravilo Vargatef (nintedanib) v primeru povečanja ravni AST in/ali ALT in bilirubina Povečanje ravni AST/ALT in bilirubina
English: Observed adverse events were consistent with the known safety profile of nintedanib, i.e. increased liver enzymes and gastrointestinal symptoms.
Slovenian: Neželeni učinki, ki so jih opazili, so bili skladni z znanim profilom varnosti nintedaniba, ki zajema povečanje jetrnih encimov in prebavnih simptomov.
English: There are no data available from clinical trials for patients with inherited predisposition to bleeding or for patients receiving a full dose of anticoagulative treatment prior to start of treatment with Vargatef (for post-marketing experience, see ‘Haemorrhage' above).
Slovenian: Podatki iz kliničnih preskušanj za bolnike z dedno nagnjenostjo h krvavitvam ali tiste, ki so pred začetkom zdravljenja z zdravilom Vargatef prejemali polne odmerke antikoagulantov, niso na voljo (za podatke v obdobju trženja glejte »Krvavitev« zgoraj).
English: Aluminium/aluminium blisters containing 10 capsules each.
Slovenian: Pretisni omoti aluminij/aluminij; vsak vsebuje 10 kapsul.
English: Female patients should be advised to notify their doctor or pharmacist if they become pregnant during therapy with Vargatef.
Slovenian: Ženskam je treba svetovati, naj obvestijo zdravnika ali farmacevta, če med zdravljenjem z zdravilom Vargatef zanosijo.
English: Drug-drug interactions between nintedanib and CYP substrates, CYP inhibitors, or CYP inducers are not expected, since nintedanib, BIBF 1202, and BIBF 1202 glucuronide did not inhibit or induce CYP enzymes in preclinical studies nor was nintedanib metabolized by CYP enzymes to a relevant extent.
Slovenian: Medsebojnega delovanja med nintedanibom in substrati CYP, zaviralci CYP ali induktorji CYP ni pričakovati, saj nintedanib, BIBF 1202 in glukuronid BIBF 1202 v predkliničnih študijah niso zavirali ali inducirali encimov CYP, pa tudi nintedaniba encimi CYP niso presnavljali v pomembnem obsegu.
English: Nintedanib and its metabolites, the free acid moiety BIBF 1202 and its glucuronide BIBF 1202 glucuronide, did not inhibit or induce CYP enzymes in preclinical studies(see section 5.2).
Slovenian: V predkliničnih študijah nintedanib in njegovi presnovki, prosta kislina BIBF 1202 in njen glukuronid BIBF 1202 niso zavirali ali inducirali encimov CYP (glejte poglavje 5.2).
English: In particular, treatment of tumour xenografts with nintedanib led to a rapid reduction in tumour micro vessel density, pericytes vessel coverage and tumour perfusion.
Slovenian: Še zlasti je zdravljenje tumorskih ksenograftov z nintedanibom hitro zmanjšalo gostoto mikrožilja v tumorju in njegovo perfuzijo ter prekritje žil s periciti.
English: In addition, 2 patients had an overdose of maximum 600 mg twice daily (b.i.d.)
Slovenian: Poleg tega sta 2 bolnika dobivala prevelik odmerek največ 600 mg dvakrat na dan do osem dni.
English: Taking the medicine this way ensures that a steady amount of nintedanib is maintained in the body.
Slovenian: Tako boste zagotovili enakomerno količino nintedaniba v telesu.
English: Vargatef has minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Vargatef ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: The recommended dose is four capsules per day (this is a total of 400 mg nintedanib per day).
Slovenian: Priporočeni odmerek so štiri kapsule na dan (skupaj 400 mg nintedaniba na dan).
English: Peripheral neuropathy is also known to occur with docetaxel treatment.
Slovenian: Znano je tudi, da se med zdravljenjem z docetakselom pojavlja periferna nevropatija.
English: Placebo Nintedanib
Slovenian: Verjetnost preživetja placebo nintedanib
English: Vargatef must not be taken on the same day of docetaxel chemotherapy administration (= day 1).
Slovenian: Bolnik ne sme vzeti zdravila Vargatef istega dne, ko prejme kemoterapijo z docetakselom (to je 1. dne).
English: The excipients are:
Slovenian: Druge sestavine zdravila so:
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 120 (2 packs of 60 x1) soft capsules.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Večkratno pakiranje: 120 (2 pakiranji s po 60 x1) mehkih kapsul.
English: The following side effects were observed under treatment with this medicine:
Slovenian: Pri zdravljenju s tem zdravilom so opazili naslednje neželene učinke:
English: Decreased appetite, Electrolyte imbalance
Slovenian: Presnovne in prehranske motnje zmanjšan apetit, neravnovesje elektrolitov dehidracija, zmanjšanje telesne mase
English: No adjustment of the starting dose is needed for patients with mild hepatic impairment (Child Pugh A) based on clinical data.
Slovenian: Začetnega odmerka pri bolnikih z blago jetrno okvaro (Child Pugh A) na podlagi kliničnih podatkov ni treba prilagajati.
English: Most patients recovered from diarrhoea following treatment interruption, anti-diarrhoeal therapy and nintedanib dose reduction.
Slovenian: Pri večini bolnikov je driska prenehala po prekinitvi zdravljenja, jemanju zdravil proti driski in zmanjšanju odmerka nintedaniba.
English: In case of bleeding, dose adjustment, interruption or discontinuation should be considered based on clinical judgement (see section 4.2).
Slovenian: V primeru krvavitve je treba razmisliti o prilagoditvi odmerka, prekinitvi ali trajni ukinitvi zdravljenja na podlagi klinične ocene (glejte poglavje 4.2).
English: No QT prolongation was observed for nintedanib in the clinical trial program (see section 5.1).
Slovenian: V programu kliničnega preskušanja z nintedanibom niso opazili podaljšanja intervala QT (glejte poglavje 5.1)
English: Total plasma clearance after intravenous infusion was high (CL: 1390 mL/min, 28.8 % gCV).
Slovenian: Skupni plazemski očistek po intravenskem infundiranju je bil velik (očistek: 1.390 ml/min, 28,8 % gCV).
English: Post-marketing bleeding events include but are not limited to gastrointestinal, respiratory and central nervous system organs, with the most frequent being respiratory (see also section 4.4).
Slovenian: Krvavitve v obdobju trženja zdravila vključujejo prebavila, dihala in organe osrednjega živčnega sistema, vendar na njih niso omejene, najbolj pogoste pa so krvavitve v dihalih (glejte tudi poglavje 4.4).
English: Hyperbilirubinaemia, Gammaglutamyltransferase (GGT) increased
Slovenian: hiperbilirubinemija, povečana vrednost gama-glutamiltrans feraze (GGT)
English: Based on increased exposure, the risk for adverse events may be increased in patients with mild hepatic impairment (Child Pugh A; see sections 4.2 and 5.2).
Slovenian: Na podlagi večje izpostavljenosti se lahko poveča tudi tveganje za neželene dogodke pri bolnikih z blago jetrno okvaro (Child Pugh A; glejte poglavji 4.2 in 5.2).