natgillin/translations-raw huggingface dataset:
Results from population pharmacokinetic modelling (data from subjects with baseline CLCR values ranging from 30.8 ml/min to 150 ml/min) indicated that renal impairment is unlikely to have clinically relevant effect on pazopanib pharmacokinetics.
Rezultati populacijskega farmakokinetičnega modeliranja (podatki od oseb z izhodiščno vrednostjo kreatininskega očistka v razponu od 30,8 ml/min do 150 ml/min) kažejo, da je malo verjetno, da bi okvara ledvic imela klinično pomemben učinek na farmakokinetiko pazopaniba.
Effects of other medicinal products on pazopanib
Vpliv drugih zdravil na pazopanib
Neutropenia, thrombocytopenia and palmar-plantar erythrodysaethesia syndrome were observed more frequently in patients of East Asian descent.
Nevtropenijo, trombocitopenijo in sindrom palmarno-plantarne eritrodizestezije so pogosteje opažali pri bolnikih vzhodnoazijskega porekla.
Soft-tissue sarcoma (STS)
Sarkom mehkih tkiv (STS)
Because the mechanism of action of pazopanib can severely affect organ growth and maturation during early post-natal development in rodents (see section 5.3), pazopanib should not be given to paediatric patients younger than 2 years of age.
Mehanizem delovanja pazopaniba lahko pri glodalcih hudo prizadene rast in dozorevanje organov med zgodnjim postnatalnim obdobjem (glejte poglavje 5.3), zato se pazopaniba ne sme uporabljati pri pediatričnih bolnikih, mlajših od 2 let.
CYP3A4, P-gp, BCRP inducers
Induktorji CYP3A4, P-gp, BCRP
Dosing recommendations in hepatically impaired patients are based on pharmacokinetic studies of pazopanib in patients with varying degrees of hepatic dysfunction (see section 5.2).
Priporočila za odmerjanje pri bolnikih z okvaro jeter temeljijo na farmakokinetičnih študijah pazopaniba pri bolnikih z različnimi stopnjami motenega delovanja jeter (glejte poglavje 5.2).
Baseline and periodic urinanalysis during treatment is recommended and patients should be monitored for worsening proteinuria.
Pred začetkom zdravljenja in periodično med zdravljenjem je priporočljivo opraviti preiskave urina, bolnike pa je treba nadzirati glede poslabšanja proteinurije.
Patients should be carefully monitored for clinical signs or symptoms of congestive heart failure.
Bolnike je treba natančno kontrolirati glede kliničnih znakov ali simptomov kongestivnega srčnega popuščanja.
- The other ingredients in the 200 mg and 400 mg tablets are: hypromellose, macrogol 400, magnesium stearate, microcrystalline cellulose, polysorbate 80, povidone (K30), sodium starch glycolate, titanium dioxide (E171).
- Druge sestavine 200 mg in 400 mg filmsko obloženih tablet so: hipromeloza, makrogol 400, magnezijev stearat, mikrokristalna celuloza, polisorbat 80, povidon (K30), natrijev karboksimetilškrob in titanov dioksid (E171).
Potential induction of human CYP3A4 was demonstrated in an in vitro human PXR assay.
Morebitna indukcija CYP3A4 je pri človeku bila dokazana in vitro s humanim PXR.
Symptoms include: - loss of speech - change of vision - seizure (fits) - confusion - high blood pressure
Med simptomi so: - izguba govora, - sprememba vida, - konvulzije (napadi krčev), - zmedenost, - visok krvni tlak.
Don't take Votrient with food.
Ne jemljite zdravila Votrient skupaj s hrano.
Votrient may cause blood clots in the small blood vessels in the kidneys and brain accompanied by a decrease in red blood cells and cells involved in clotting (thrombotic microangiopathy, TMA).
Zdravilo Votrient lahko povzroči nastanek krvnih strdkov v majhnih krvnih žilah ledvic in možganov, ki jih spremlja zmanjšanje števila rdečih krvnih celic in celic, ki sodelujejo pri strjevanju krvi (trombotična mikroangiopatija).
Votrient treatment should only be initiated by a physician experienced in the administration of anti-cancer medicinal products.
Zdravljenje z zdravilom Votrient sme uvesti le zdravnik, ki ima izkušnje z uporabo protitumorskih zdravil.
‘Other STS' subgroups
Podskupina "drugi STS"
This can result in weight increase and tiredness.
To lahko povzroči povečanje telesne mase in utrujenost.
Adverse drug reactions, all grades, which were reported in RCC and STS subjects or during the post-marketing period are listed below by MedDRA body system organ class, frequency and grade of severity.
Neželeni učinki zdravila (vseh stopenj), o katerih so poročali pri preiskovancih z RCC in STS ali v obdobju po prihodu zdravila na trg, so v nadaljevanju navedeni po MedDRA podatkovni bazi glede na organske sisteme, pogostnosti in stopnjo resnosti.
Patients with only a mild indirect hyperbilirubinaemia, known or suspected Gilbert's syndrome, and elevation in ALT >3 x ULN should be managed as per the recommendations outlined for isolated ALT elevations.
Bolnike z le blago indirektno hiperbilirubinemijo ali znanim Gilbertovim sindromom ali sumom nanj ter z ALT > 3-kratno ZMN je treba obravnavati po priporočilih, opisanih za primer izoliranega zvišanja ALT.
†Treatment-related adverse reaction reported during post-marketing period (spontaneous case reports and serious adverse reactions from all pazopanib clinical studies).
† Z zdravljenjem povezani neželeni učinki, o katerih so poročali v obdobju trženja (spontano prijavljeni primeri in resni neželeni učinki iz vseh kliničnih študij s pazopanibom).
Swelling of the brain (reversible posterior leukoencephalopathy syndrome) Votrient can, on rare occasions, cause swelling of the brain, which may be life threatening.
Oteklost možganov (reverzibilni posteriorni levkoencefalopatski sindrom) Zdravilo Votrient lahko v redkih primerih povzroči otekanje možganov, ki je lahko smrtno nevarno.
Medicinal products that raise gastric pH
Zdravila, ki zvišujejo pH v želodcu
“Other STS” subgroups*
Podskupine "drugi STS"*
Interstitial lung disease (ILD)/Pneumonitis
Intersticijska bolezen pljuč (IBP)/pnevmonitis
If you have high blood pressure you will be treated with medicines to reduce it.
Če imate visok krvni tlak, vam bo zdravnik predpisal zdravila za zdravljenje visokega krvnega tlaka.
The safety, efficacy and quality of life of pazopanib versus sunitinib was evaluated in a randomised, open-label, parallel group Phase III non-inferiority study (VEG108844).
Varnost, učinkovitost in kakovost življenja s pazopanibom v primerjavi s sunitinibom so ocenili v randomizirani, odprti študiji neinferiornosti faze III z vzporednimi skupinami (VEG108844).
In vitro, pazopanib inhibited human organic anion transporting polypeptide (OATP1B1).
In vitro je pazopanib zavrl humani transportni polipeptid za organske anione (OATP1B1).
Votrient can, on rare occasions, cause lung inflammation (interstitial lung disease, pneumonitis), which in some people can be fatal.
Zdravilo Votrient lahko v redkih primerih povzroči vnetje pljuč (intersticijsko bolezen pljuč, pnevmonitis), ki je lahko za nekatere bolnike smrtno.
Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, protein kinase inhibitors, ATC code: L01XE11
Farmakoterapevtska skupina: Zdravila z delovanjem na novotvorbe, druga zdravila z delovanjem na novotvorbe, zaviralci proteinskih kinaz, oznaka ATC: L01XE11
Votrient is indicated for the treatment of adult patients with selective subtypes of advanced soft-tissue sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo) adjuvant therapy.
Zdravilo Votrient je indicirano za zdravljenje odraslih bolnikov z določenimi podvrstami napredovalega sarkoma mehkih tkiv (STS - soft tissue sarcoma), ki so predhodno prejemali kemoterapijo zaradi metastatske bolezni ali jim je bolezen napredovala v 12 mesecih po (neo)adjuvantnem zdravljenju.
Possible serious side effects
Možni resni neželeni učinki
Hypertensive crisis (sudden and severe rise in blood pressure) Votrient can on occasion cause a sudden and severe rise in blood pressure.
Hipertenzivna kriza (nenaden porast krvnega tlaka na zelo visoke vrednosti) Zdravilo Votrient lahko občasno povzroči nenaden porast krvnega tlaka na zelo visoke vrednosti.
Pazopanib should be used with caution in patients who are at increased risk of thrombotic events or who have had a history of thrombotic events.
Pazopanib je treba previdno uporabljati pri bolnikih, ki imajo večje tveganje za trombotične dogodke ali imajo trombotične dogodke v anamnezi.
These results indicate that the bioavailability and the rate of pazopanib oral absorption are increased after administration of the crushed tablet relative to administration of the whole tablet (see section 4.2).
Ti rezultati kažejo, da se biološka uporabnost in stopnja absorpcije pazopaniba pri peroralni uporabi zdrobljene tablete v primerjavi z uporabo cele tablete poveča (glejte poglavje 4.2).
In vivo, pazopanib inhibited VEGF-induced VEGFR-2 phosphorylation in mouse lungs, angiogenesis in various animal models, and the growth of multiple human tumour xenografts in mice.
In vivo je pazopanib zaviral z žilnim endotelijskim rastnim faktorjem povzročeno fosforilacijo VEGFR-2 v pljučih miši, angiogenezo pri različnih živalskih modelih in rast multiplih humanih tumorskih ksenogenskih presadkov pri miših.
Votrient can lower the amount of thyroid hormone produced in your body.
Zdravilo Votrient lahko zmanjša tvorbo ščitničnih hormonov v telesu.
Patients (N = 435) with locally advanced and/or metastatic RCC were randomised to receive pazopanib 800 mg once daily or placebo.
Bolniki (n = 435) z lokalno napredovalim in/ali metastatskim RCC so bili randomizirani tako, da so prejemali pazopanib v odmerku 800 mg enkrat na dan ali placebo.
The usual dose is two Votrient 400 mg tablets (800 mg pazopanib) taken once a day.
Običajen odmerek sta dve 400 mg tableti zdravila Votrient (800 mg pazopaniba) enkrat na dan.
It is not known whether the ingredients in Votrient pass into breast milk.
Ni znano, če se sestavine zdravila Votrient izločajo z materinim mlekom.
Votrient can make some conditions worse or cause serious side effects.
Zdravilo Votrient lahko poslabša nekatera zdravstvena stanja ali povzroči resne neželene učinke.
CYP3A4, P-gp, BCRP inhibitors Pazopanib is a substrate for CYP3A4, P-gp and BCRP.
Zaviralci CYP3A4, P-gp, BCRP Pazopanib je substrat CYP3A4, P-gp in BCRP.
Human paediatric patients are at increased risk for bone and teeth effects as compared to adults, as these changes, including inhibition of growth (shortened limbs), fragile bones and remodelling of teeth, were present in juvenile rats at ≥10 mg/kg/day (equal to approximately 0.1-0.2 times the clinical exposure based on AUC in adult humans) (see section 4.4).
Pri človeku obstaja pri pediatričnih bolnikih večje tveganje za učinke na kosti in zobe kot pri odraslih: te spremembe - vključno z zavrtjem rasti (krajši udi), krhkimi kostmi in remodeliranjem zob - so bile pri mladih podganah prisotne pri ≥ 10 mg/kg/dan (to je približno 0,1- do 0,2-kratnik klinične izpostavljenosti na podlagi AUC pri odraslih ljudeh) (glejte poglavje 4.4).
Upon oral administration of a single pazopanib 800 mg dose to patients with solid tumours, maximum plasma concentration (Cmax) of approximately 19 ± 13 µg/ml was obtained after median 3.5 hours (range 1.0-11.9 hours) and an AUC0-∞ of approximately 650 ± 500 µg.h/ml was obtained.
Po peroralni uporabi enkratnega 800 mg odmerka pazopaniba je bila pri bolnikih s solidnim tumorjem dosežena največja plazemska koncentracija (Cmax) približno 19 ± 13 µg/ml po mediani vrednosti 3,5 ure (razpon od 1,0 do 11,9 ur) in dosežena vrednost AUC0-∞ približno 650 ± 500 µg.h/ml.
It cannot be excluded that pazopanib will affect the pharmacokinetics of substrates of OATP1B1 (e.g. statins, see “Effect of concomitant use of pazopanib and simvastatin” below).
Vpliva pazopaniba na farmakokinetiko substratov OATP1B1 (npr. statinov, glejte ''Vpliv sočasne uporabe pazopaniba in simvastatina” spodaj) ni mogoče izključiti.
In the RCC studies of pazopanib, overall no clinically significant differences in safety of pazopanib were observed between subjects aged at least 65 years and younger subjects.
V kliničnih študijah RCC, izvedenih s pazopanibom, se varnost uporabe pazopaniba pri bolnikih, starih vsaj 65 let, v celoti klinično ni pomembneje razlikovala od varnosti pri mlajših bolnikih.
All patients should have liver function tests to determine whether they have hepatic impairment before starting and during pazopanib therapy (see section 4.4).
Pri vseh bolnikih je treba opraviti teste jetrne funkcije, da bi ugotovili morebitno okvaro jeter; opraviti jih je treba pred začetkom zdravljenja in med zdravljenjem s pazopanibom (glejte poglavje 4.4).
Continue on pazopanib with weekly monitoring of liver function until transaminases return to Grade 1 or baseline.
Nadaljujte zdravljenje s pazopanibom s tedenskim spremljanjem delovanja jeter, dokler se vrednosti aminotransferaz ne vrnejo na stopnjo 1 ali izhodiščno vrednost.
The primary objective of this study was to evaluate and compare PFS in patients treated with pazopanib to those treated with sunitinib.
Primarni cilj študije je bila ocena in primerjava preživetja brez napredovanja pri bolnikih, zdravljenih s pazopanibom, in bolnikih, zdravljenih s sunitinibom.
Votrient can cause separation or tear of the lining of the back part of the eye (retinal detachment or tear).
Zdravilo Votrient lahko povzroči odstop ali pretrganje tanke plasti na zadnji strani očesnega zrkla (odstop mrežnice ali pretrganje mrežnice).
Votrient is indicated in adults for the first-line treatment of advanced renal cell carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease.
Zdravilo Votrient je pri odraslih indicirano kot zdravilo prvega izbora za zdravljenje napredovalega karcinoma ledvičnih celic (RCC - renal cell carcinoma) in pri bolnikih, ki so zaradi napredovale bolezni predhodno prejemali zdravljenje s citokini.
If pazopanib is used during pregnancy, or if the patient becomes pregnant while receiving pazopanib, the potential hazard to the foetus should be explained to the patient.
Če se pazopanib uporablja med nosečnostjo, ali če bolnica med zdravljenjem s pazopanibom zanosi, ji je treba pojasniti možno tveganje za plod.
The efficacy and safety of pazopanib in STS were evaluated in a pivotal Phase III randomised, double-blind, placebo-controlled multicentre study (VEG110727).
Varnost in učinkovitost pazopaniba pri STS so ocenili v ključni randomizirani, dvojno slepi, s placebom kontrolirani multicentrični študiji faze III (VEG110727).
Infections (with or without neutropenia)†
Infekcijske in parazitske bolezni pogosti okužbe (z nevtropenijo ali brez nje)†
Women of childbearing potential should be advised to use adequate contraception during treatment and for at least 2 weeks after the last dose of pazopanib and to avoid becoming pregnant while receiving treatment with pazopanib.
Ženskam v rodni dobi je treba svetovati uporabo primerne metode kontracepcije med zdravljenjem in še najmanj 2 tedna po zadnjem odmerku pazopaniba in pojasniti, da med zdravljenjem s pazopanibom ne smejo zanositi.
Fatal perforation events have occurred.
Pojavile so se perforacije s smrtnim izidom.
Not known (frequency cannot be estimated from the available data): - an enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall
Neznana pogostnost (je ni mogoče ocenti iz razpoložljivih podatkov): - razširitev in oslabitev stene krvne žile ali raztrganina v steni krvne žile (anevrizme in disekcije arterij).
Furthermore, inhibition of BCRP and P-gp by pazopanib in the gastrointestinal tract cannot be excluded.
Poleg tega ni mogoče izključiti zavrtja BCRP in P-gp s pazopanibom v prebavilih.
A synthetic intermediate in manufacture of pazopanib, which is also present in the final drug substance in low amounts, was not mutagenic in the Ames assay but genotoxic in the mouse lymphoma assay and in vivo mouse micronucleus assay.
Sintetični intermediat, ki se uporablja pri izdelavi pazopaniba in je v majhnih količinah prisoten tudi v končni zdravilni učinkovini pri Amesovem testu ni deloval mutageno, je pa bil genotoksičen pri testu na mišjem limfomu ter in vivo testu na mišjih mikronukleusih.
Concomitant administration of pazopanib with uridine diphosphate glucuronosyl transferase 1A1 (UGT1A1) substrates (e.g. irinotecan) should be undertaken with caution since pazopanib is an inhibitor of UGT1A1 (see section 4.5).
Pri sočasni uporabi pazopaniba in substratov za uridin-difosfat-glukuronoziltransferazo 1A1 (UGT1A1) (npr. irinotekan) je potrebna previdnost, ker je pazopanib inhibitor UGT1A1 (glejte poglavje 4.5).
Dose modification (decrease or increase) should be in 200 mg decrements or increments in a stepwise fashion based on individual tolerability in order to manage adverse reactions.
Odmerek je treba prilagajati (zniževati ali zviševati) postopoma, z nižanjem ali višanjem odmerka v korakih po 200 mg in pri tem upoštevati prenašanje zdravila pri posameznem bolniku zaradi obvladovanja neželenih učinkov.
Effect of food on pazopanib
Vpliv hrane na pazopanib
In each treatment group, there was a slightly greater percentage of subjects in the 2+ lines of prior systemic therapy for advanced disease (58% and 55%, respectively, for placebo and pazopanib treatment arms) compared with 0 or 1 lines of prior systemic therapy (42% and 45%, respectively, for placebo and pazopanib treatment arms).
V vsaki terapevtski skupini je bil rahlo večji odstotek preiskovancev z 2 ali več linijami predhodnega sistemskega zdravljenja napredovale bolezni (58 % v skupini s placebom, 55 % v skupini s pazopanibom) kot z 0 ali 1 linijo predhodnega sistemskega zdravljenja (42 % v skupini s placebom in 45 % v skupini s pazopanibom).
No statistical differences were observed between treatment groups for Global Quality of Life using EORTC QLQ-C30 and EuroQoL EQ-5D.
Skupna kvaliteta življenja na osnovi EORTC QLQ-C30 in EuroQoL EQ-5D se med obema skupinama zdravljenja statistično ni razlikovala.
It can occur in muscles, blood vessels, fat tissue or other tissues that support,
Pojavi se lahko v mišicah, žilah, maščobnem tkivu ali drugih tkivih, ki podpirajo, obdajajo in varujejo organe.
Patients developing PRES/RPLS should permanently discontinue treatment with pazopanib.
Bolniki, ki se jim pojavi PRES/RPLS, morajo trajno prenehati z zdravljenjem s pazopanibom.
Co-administration of pazopanib with other strong inhibitors of the CYP3A4 family (e.g. itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) may increase pazopanib concentrations.
Pri sočasni uporabi pazopaniba in ostalih zdravil iz skupine močnih zaviralcev CYP3A4 (npr. itrakonazol, klaritromicin, atazanavir, indinavir, nefazodon, nelfinavir, ritonavir, sakvinavir, telitromicin, vorikonazol) se koncentracije pazopaniba lahko povečajo.
Votrient can cause a tear (perforation) in your stomach or intestinal wall or the development of an abnormal connection between two parts of your digestive tract (a fistula).
Zdravilo Votrient lahko povzroči predrtje (perforacijo) stene želodca ali črevesa ali razvoj neobičajnih povezav med dvema deloma prebavnega trakta (fistula).
Concomitant treatment with strong inhibitors of CYP3A4, P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) should be avoided due to risk of increased exposure to pazopanib (see section 4.5).
Sočasnemu zdravljenju z močnimi zaviralci CYP3A4, P-glikoproteina (P-gp) ali proteina BCRP se je treba izogniti, ker obstaja tveganje večje izpostavljenosti pazopanibu (glejte poglavje 4.5).
Pazopanib should be administered at least 1 hour before or 2 hours after administration of short-acting antacids.
Pazopanib je treba vzeti vsaj 1 uro pred ali 2 uri po uporabi kratkodelujočih antacidov.
Table 6 Overall efficacy results in STS by independent assessment (VEG110727)
Preglednica 6 Rezultati celokupne učinkovitosti pri STS po neodvisni oceni (VEG110727)
- If you do become pregnant during treatment with Votrient, tell your doctor.
- Če med zdravljenjem z zdravilom Votrient zanosite, o tem obvestite svojega zdravnika.
In a randomised study comparing pazopanib and sunitinib in RCC (VEG108844), subjects had baseline and follow up LVEF measurements.
V randomizirani primerjalni študiji pazopaniba in sunitiniba pri karcinomu ledvičnih celic (VEG108844) so preiskovancem opravili izhodiščno meritev in kontrolne meritve LVEF.
The safety and efficacy of pazopanib in RCC were evaluated in a randomised, double-blind, placebo-controlled multicentre study.
Varnost in učinkovitost pazopaniba pri karcinomu ledvičnih celic je bila ovrednotena z randomizirano, dvojno slepo, s placebom nadzorovano multicentrično študijo.
It is not known whether pazopanib or its metabolites are excreted in human milk.
Ni znano, ali se pazopanib ali njegovi presnovki izločajo z materinim mlekom.
Signs and symptoms of stroke may include: - numbness or weakness on one side of your body - difficulty talking - headache - dizziness
Znaki in simptomi možganske kapi lahko vključujejo: - odrevenelost ali šibkost ene strani vašega telesa, - težave pri govorjenju, - glavobol, - omotico.
Interruption of pazopanib and/or dose reduction should be combined with treatment of hypertension (if present, refer to hypertension warning section above) in patients with significant reductions in LVEF, as clinically indicated.
Pri bolnikih s pomembnim zmanjšanjem LVEF je treba zdravljenje s pazopanibom prekiniti in/ali zmanjšati odmerek ter to kombinirati z zdravljenjem hipertenzije (če je ta prisotna, glejte poglavje z opozorili glede hipertenzije zgoraj), kot je klinično indicirano.
Venous thromboembolic events
Venski trombembolični dogodki
In the cytokine pre-treated subgroup, the majority (75%) had received interferon-based treatment.
V podskupini bolnikov, ki so se predhodno že zdravili s citokini, se je večina bolnikov (75 %) zdravila z interferoni.
Pre-clinical studies in animals have shown reproductive toxicity (see section 5.3).
Predklinične študije na živalih so pokazale reproduktivno toksičnost (glejte poglavje 5.3).
Endpoints / study population
Opazovani dogodek/Študijska populacija
Within each system organ class, adverse reactions with the same frequency are presented in order of decreasing seriousness.
V razvrstitvah pogostnosti znotraj posameznega organskega sistema so neželeni učinki navedeni po padajoči resnosti.
In juvenile toxicity studies, when pre-weaning rats were dosed from day 9 post partum through to day 14 post partum, pazopanib caused mortalities and abnormal organ growth/maturation in kidney, lung, liver and heart, at a dose approximately 0.1 times the clinical exposure based on AUC in adult humans.
V študijah juvenilne toksičnosti, v katerih so podgane pred prenehanjem dojenja prejemale pazopanib od 9. do 14. postpartalnega dneva, je pazopanib povzročil poginjanje in nenormalno rast/dozorevanje organov (ledvic, pljuč, jeter in srca) v odmerkih, ki so bili približno 0,1-kratnik klinične izpostavljenosti na podlagi AUC pri odraslih ljudeh.
A similar improvement in PFS based on investigator assessments was observed in the pazopanib arm compared with the placebo arm (in the overall ITT population HR: 0.39; 95% CI, 0.30 to 0.52, p <0.001).
Izboljšanje PFS v skupini s pazopanibom v primerjavi s placebom je bilo po oceni raziskovalcev podobno (razmerje ogroženosti v celotni populaciji ITT: 0,39, 95 % IZ od 0,30 do 0,52, p < 0,001).
Care should be taken when pazopanib is co-administered with other oral BCRP and P-gp substrates.
Previdnost je potrebna, če je pazopanib uporabljen hkrati z drugimi peroralnimi substrati BCRP in P-gp.
In a rat male fertility study, there was no effect on mating or fertility, but decreased testicular and epididymal weights were noted with reductions in sperm production rates, sperm motility, and epididymal and testicular sperm concentrations observed at exposures 0.3 times human exposure based on AUC.
Pri študiji plodnosti pri samcih podgan niso opazili učinkov na parjenje ali plodnost, opazili pa so zmanjšanje mase mod in epididimisov z manjšim nastajanjem sperme, manjšo gibljivostjo semenčic in manjšo koncentracijo sperme v nadmodkih in modih, in sicer pri izpostavljenosti, ki je na osnovi AUC ustrezala 0,3-kratni izpostavljenosti človeka.