FrancophonIA/ELRC3.0 huggingface dataset:
English: Axitinib should not be used during breast-feeding.
Croatian: Aksitinib se ne smije uzimati za vrijeme dojenja.
English: • The other ingredients are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, hypromellose 2910 (15 mPa·s), titanium dioxide (E171), triacetin (E1518), iron oxide red (E172) (see section 2 Inlyta contains lactose (milk sugar)).
Croatian: Drugi sastojci su: mikrokristalična celuloza, laktoza hidrat, umrežena karmelozanatrij, magnezijev stearat, hipromeloza 2910 (15 mPa s), titanijev dioksid (E171), triacetin (E1518) i crveni željezov oksid (E172) (vidjeti dio „Inlyta sadrži laktozu (mliječni šećer)“).
English: It is unknown whether axitinib is excreted in human milk.
Croatian: Nije poznato izlučuje li se aksitinib u majčino mlijeko.
English: • rifampicin, rifabutin or rifapentin, used to treat tuberculosis (TB);
Croatian: • rifampicin, rifabutin ili rifapentin, koji se koriste za liječenje tuberkuloze,
English: Axitinib inhibited the phosphorylation of VEGFR-2 in xenograft tumour vasculature that expressed the target in vivo and produced tumour growth delay, regression, and inhibition of metastases in many experimental models of cancer.
Croatian: Aksitinib je inhibirao fosforilaciju VEGFR-2 u ksenotransplantacijskim modelima tumorskog krvožilja koje predstavlja cilj djelovanja in vivo, a u mnogim je eksperimentalnim modelima raka uzrokovao odgodu rasta, regresiju te inhibiciju metastaziranja tumora.
English: Not known Aneurysms and artery dissectionsd
Croatian: d,j nepoznato aneurizme i disekcije arterije
English: • atazanavir, indinavir, nelfinavir, ritonavir or saquinavir, used to treat HIV infections/AIDS;
Croatian: • atazanavir, indinavir, nelfinavir, ritonavir ili sakvinavir, koji se koriste za liječenje HIV
English: m Including acute renal failure n Cholecystitis includes Cholecystitis acute, Cholecystitis, Cholecystitis infective.
Croatian: uključujući akutno zatajenje bubrega. kolecistitis uključuje akutni kolecistitis, kolecistitis, infektivni kolecistitis
English: • Do not breast-feed during treatment with Inlyta.
Croatian: • Nemojte dojiti za vrijeme liječenja lijekom Inlyta.
English: Microcrystalline cellulose Lactose monohydrate Croscarmellose sodium Magnesium stearate
Croatian: Jezgra tablete celuloza, mikrokristalična laktoza hidrat karmelozanatrij, umrežena magnezijev stearat
English: Compared to subjects with normal hepatic function, systemic exposure following a single dose of axitinib was similar in subjects with mild hepatic impairment (Child-Pugh class A) and higher (approximately two-fold) in subjects with moderate hepatic impairment (Child-Pugh class B).
Croatian: U odnosu na ispitanike s normalnom funkcijom jetre, sistemska izloženost nakon jedne doze aksitiniba bila je podjednaka u ispitanika s blagim oštećenjem jetre (Child-Pugh stadij A), a veća (približno dvostruko) u ispitanika s umjerenim oštećenjem jetre (Child-Pugh stadij B).
English: Rifampicin, a strong inducer of CYP3A4/5, administered at a dose of 600 mg once daily for 9 days, reduced the mean AUC by 79% and Cmax by 71% of a single 5 mg dose of axitinib in healthy volunteers.
Croatian: Rifampicin, snažan induktor CYP3A4/5, primijenjen zdravim dobrovoljcima u dozi od 600 mg jedanput na dan tijekom 9 dana, smanjio je prosječan AUC aksitiniba nakon jedne doze od 5 mg za 79%, a Cmax za 71%.
English: Categories have been assigned based on absolute frequencies in the pooled clinical studies data.
Croatian: Kategorije učestalosti određene su na temelju apsolutne učestalosti u objedinjenim kliničkim ispitivanjima.
English: • phenytoin, carbamazepine or phenobarbital, anti-epileptics used to stop seizures or fits;
Croatian: • fenitoin, karbamazepin ili fenobarbital, antiepileptici koji se koriste za zaustavljanje konvulzija ili epileptičkih napadaja,
English: If you have any questions about how this medicine works or why this medicine has been prescribed for you, ask your doctor.
Croatian: Ako imate pitanja o tome kako ovaj lijek djeluje ili zašto
English: In patients with signs or symptoms of PRES, temporarily interrupt or permanently discontinue axitinib treatment.
Croatian: U bolesnika sa znakovima ili simptomima PRES-a treba privremeno prekinuti ili trajno obustaviti terapiju aksitinibom.
English: h Including activated partial thromboplastin time prolonged, anal haemorrhage, arterial haemorrhage, blood urine present, central nervous system haemorrhage, cerebral haemorrhage, coagulation time prolonged, conjunctival haemorrhage, contusion, diarrhea haemorrhagic, dysfunctional uterine bleeding, epistaxis, gastric haemorrhage, gastrointestinal haemorrhage, gingival bleeding, haematemesis, haematochezia, haematocrit decreased, haematoma, haematuria, haemoglobin decreased, haemoptysis, haemorrhage, haemorrhage coronary artery, haemorrhage urinary tract, haemorrhoidal haemorrhage, haemostasis, increased tendency to bruise, international normalized ratio increased, lower gastrointestinal haemorrhage, melaena, petechiae, pharyngeal haemorrhage, prothrombin time prolonged, pulmonary haemorrhage, purpura, rectal haemorrhage, red blood cell count decreased, renal haemorrhage, scleral haemorrhage, scrotal haematocoele, splenic haemotoma, splinter haemorrhage, subarachnoid haemorrhage, tongue haemorrhage, upper gastrointestinal haemorrhage and vaginal haemorrhage.
Croatian: uključujući produženo aktivirano parcijalno tromboplastinsko vrijeme, analno krvarenje, arterijsko krvarenje, prisutnost krvi u mokraći, krvarenje središnjeg živčanog sustava, cerebralno krvarenje, produženo vrijeme koagulacije, konjuktivno krvarenje, kontuziju, krvavi proljev, disfunkcionalno krvarenje iz maternice, epistaksu, želučano krvarenje, krvarenje u probavnom traktu, krvarenje gingive, hematemezu, hematoheziju, smanjenu razinu hematokrita, hematom, hematuriju, smanjenu razinu hemoglobina, hemoptizu, krvarenje, krvarenje koronarne arterije, krvarenje mokraćnog trakta, hemoroidno krvarenje, hemostazu, povećanu sklonost stjecanja modrica, povećani međunarodni normalizirani omjer, krvarenje u donjem dijelu probavnog trakta, melenu, petehije, faringealno krvarenje, produženo protrombinsko vrijeme, plućno krvarenje, purpuru, rektalno krvarenje, smanjen broj crvenih krvnih stanica, bubrežno krvarenje, skleralno krvarenje, skrotalnu hematokelu, hematom slezene, krvarenje ispod noktiju, subarahnoidno krvarenje, krvarenje jezika, krvarenje u gornjem dijelu probavnog trakta i vaginalno krvarenje.
English: In vitro and in vivo data indicate that axitinib is primarily metabolised by the liver.
Croatian: Podaci prikupljeni in vitro i in vivo pokazuju da se aksitinib prvenstveno metabolizira u jetri.
English: In a clinical dose-finding study, concurrent elevations of ALT (12 times the ULN) and bilirubin (2.3 times the ULN), considered to be drug-related hepatotoxicity, were observed in 1 patient who received axitinib at a starting dose of 20 mg twice daily (4 times the recommended starting dose).
Croatian: U kliničkom ispitivanju za utvrđivanje doze, istodobno povišenje ALT-a (12 puta iznad GGN) i bilirubina (2,3 puta iznad GGN), što se smatra hepatotoksičnošću izazvanom lijekovima, opaženo je u jednog bolesnika koji je primao aksitinib u početnoj dozi od 20 mg dvaput na dan (4 puta više od preporučene početne doze).
English: Tumours (RECIST).
Croatian: Response Evaluation Criteria in Solid Tumours, RECIST).
English: Therefore, the product information should be updated to include cholecystitis as an ADR in section 4.8 of the SmPC and section 4 of the PL, with frequency ‘common'.
Croatian: Stoga informacije o lijeku treba dopuniti kako bi se kolecistitis kao nuspojava uključio u dio 4.8 sažetka opisa svojstava lijeka i dio 4 upute o lijeku, s učestalošću „često“.
English: Co-administration of axitinib with strong CYP3A4/5 inhibitors (e.g. ketoconazole, itraconazole, clarithromycin, erythromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin) may increase axitinib plasma concentrations.
Croatian: Istodobna primjena aksitiniba sa snažnim inhibitorima CYP3A4/5 (npr. ketokonazolom, itrakonazolom, klaritromicinom, eritromicinom, atazanavirom, indinavirom, nefazodonom, nelfinavirom, ritonavirom, sakvinavirom i telitromicinom) može povećati koncentracije aksitiniba u plazmi.
English: The following risks, including appropriate action to be taken, are discussed in greater detail in section 4.4: cardiac failure events, hypertension, thyroid dysfunction, arterial thromboembolic events, venous thromboembolic events, elevation of haemoglobin or haematocrit, haemorrhage, gastrointestinal perforation and fistula formation, wound healing complications, PRES, proteinuria, and elevation of liver enzymes.
Croatian: O sljedećim se rizicima, uključujući i odgovarajuće mjere koje treba poduzeti, detaljnije raspravlja u dijelu 4.4: događaji zatajenja srca, hipertenzija, poremećaj funkcije štitnjače, arterijski tromboembolijski događaji, venski tromboembolijski događaji, povišene razine hemoglobina i hematokrita, krvarenje, gastrointestinalna perforacija i stvaranje fistule, otežano cijeljenje rana, PRES, proteinurija i povišene razine jetrenih enzima.
English: Administration of axitinib with a moderate fat meal resulted in 10% lower exposure compared to overnight fasting.
Croatian: Primjena aksitiniba uz umjereno mastan obrok rezultirala je 10% manjom izloženošću u usporedbi s primjenom natašte.
English: Axitinib has not been studied in patients who had an arterial embolic or thrombotic event within the previous 12 months.
Croatian: Aksitinib nije ispitivan u bolesnika koji su u prethodnih 12 mjeseci imali neki arterijski embolijski ili trombotski događaj.
English: Venous embolic and thrombotic events
Croatian: Venski embolijski i trombotski događaji
English: Each blister pack contains 28 tablets or 56 tablets.
Croatian: Svako blister pakiranje sadrži 28 ili 56 tableta.
English: A dose decrease is recommended when administering axitinib to patients with moderate hepatic impairment (Child-Pugh class B) (e.g. the starting dose should be reduced from 5 mg twice daily to 2 mg twice daily).
Croatian: Preporučuje se sniženje doze aksitiniba kada se primjenjuje u bolesnika s umjerenim oštećenjem jetre (Child-Pugh stadij B) (npr. početnu dozu treba smanjiti s 5 mg dvaput na dan na 2 mg dvaput na dan).
English: Unchanged axitinib was not detected in urine; the carboxylic acid and sulfoxide metabolites accounted for the majority of radioactivity in urine.
Croatian: U mokraći nije utvrđen nepromijenjen aksitinib; većinu radioaktivnosti u mokraći predstavljali su karboksilna kiselina i sulfoksidni metaboliti.
English: Axitinib-related findings in the testes and epididymis included decreased organ weight, atrophy or degeneration, decreased numbers of germinal cells, hypospermia or abnormal sperm forms, and reduced sperm density and count.
Croatian: Nalazi povezani s aksitinibom na testisima i epididimisu uključuju smanjenu masu, atrofiju ili degeneraciju organa, smanjen broj germinativnih stanica, hipospermiju ili patološke oblike spermija kao i smanjenu gustoću i broj spermija.
English: These findings were observed in mice at exposure levels approximately 12-fold the expected human exposure, and in dogs at exposure levels below the expected human exposure.
Croatian: Ovi su nalazi utvrđeni u miševa pri razini izloženosti približno 12 puta većoj od očekivane izloženosti u ljudi, a u pasa pri razini izloženosti manjoj od očekivane izloženosti u ljudi.
English: Other side effects with Inlyta may include:
Croatian: Ostale nuspojave s lijekom Inlyta mogu uključivati:
English: Carcinogenicity Carcinogenicity studies have not been performed with axitinib.
Croatian: Kancerogenost Nisu provedena ispitivanja kancerogenosti aksitiniba.
English: Axitinib has been shown to potently inhibit VEGF-mediated endothelial cell proliferation and survival.
Croatian: Pokazalo se da aksitinib snažno inhibira VEGF-om posredovanu proliferaciju i preživljenje endotelnih stanica.
English: Take your next dose at your regular time.
Croatian: Uzmite sljedeću dozu u predviđeno vrijeme.
English: In vitro binding of axitinib to human plasma proteins is > 99% with preferential binding to albumin and moderate binding to α1-acid glycoprotein.
Croatian: Aksitinib se in vitro veže za proteine u ljudskoj plazmi u opsegu od > 99%, prvenstveno za albumin te umjereno za α1-kiseli glikoprotein.
English: Peak axitinib concentrations in plasma are generally reached within 4 hours following oral administration of axitinib with median Tmax ranging from 2.5 to 4.1 hours.
Croatian: Vršne koncentracije aksitiniba u plazmi u pravilu se postižu unutar 4 sata nakon peroralne primjene, a prosječan Tmax kreće se u rasponu od 2,5 do 4,1 sat.
English: Management of cardiac failure events may require temporary interruption or permanent discontinuation and/or dose reduction of axitinib therapy.
Croatian: Zbrinjavanje događaja zatajenja srca može zahtijevati privremen ili trajan prekid primjene i/ili smanjenje doze aksitiniba.
English: • Flatulence (wind), haemorrhoids, bleeding from gums, bleeding from the rectum, a burning or stinging sensation in the mouth
Croatian: • nadutost (vjetrovi), hemoroidi, krvarenje iz desni, krvarenje iz rektuma, osjećaj žarenja ili bockanja u ustima
English: Arterial embolic and thrombotic events
Croatian: Arterijski embolijski i trombotski događaji
English: • Blood clots in your veins and arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis.
Croatian: • krvni ugrušci u venama i arterijama (vrste krvnih žila), uključujući moždani udar, srčani udar, emboliju ili trombozu.
English: • Skin itching, redness of the skin, hair loss
Croatian: • svrbež kože, crvenilo kože, opadanje kose
English: If you accidentally take too many tablets or a higher dose than you need, contact a doctor for advice right away.
Croatian: Ako slučajno uzmete previše tableta ili veću dozu nego što
English: Axitinib has not been studied in patients who had a venous embolic or thrombotic event within the previous 6 months.
Croatian: Aksitinib nije ispitivan u bolesnika koji su u prethodnih 6 mjeseci imali neki venski embolijski ili trombotski događaj.
English: Dosing of axitinib at 5 mg twice daily resulted in less than two-fold accumulation compared to administration of a single dose.
Croatian: Primjena doze aksitiniba od 5 mg dvaput na dan rezultirala je manje nego dvostrukom kumulacijom u odnosu na
English: Reduced fertility and embryonic viability were observed in female mice at all doses tested, with exposure levels at the lowest dose approximately 10-fold the expected human exposure.
Croatian: Smanjena plodnost i održivost embrija opažene su u ženki miševa pri svim ispitivanim dozama, pri čemu je razina izloženosti kod primjene najniže doze bila približno 10 puta veća od očekivane izloženosti u ljudi.
English: Although axitinib dose adjustment has not been studied in patients receiving strong CYP3A4/5 inducers, if a strong CYP3A4/5 inducer must be co-administered, a gradual dose increase of axitinib is recommended.
Croatian: Iako nije ispitivana prilagodba doze aksitiniba u bolesnika koji primaju snažne induktore CYP3A4/5, ako se mora istodobno primijeniti snažan induktor CYP3A4/5, preporučuje se postupno povećavati dozu aksitiniba.
English: i
Croatian: e
English: If you vomit while taking Inlyta
Croatian: Ako povraćate tijekom uzimanja lijeka Inlyta
English: The following medicines may increase the risk of side effects with Inlyta:
Croatian: Sljedeći lijekovi mogu povećati rizik od nuspojava lijeka Inlyta:
English: One-sided p-value from Cochran-Mantel-Haenszel test of treatment stratified by ECOG performance status.
Croatian: Jednostrana p-vrijednost iz Cochran-Mantel-Haenszelovog testa terapije stratificiranog prema ECOG statusu.
English: The most common (≥ 20%) adverse reactions observed following treatment with axitinib were diarrhoea, hypertension, fatigue, decreased appetite, nausea, weight decreased, dysphonia, palmar-plantar erythrodysaesthesia (hand-foot) syndrome, haemorrhage, hypothyroidism, vomiting, proteinuria, cough, and constipation.
Croatian: Najčešće (≥ 20%) nuspojave opažene nakon terapije aksitinibom bile su proljev, hipertenzija, umor, smanjenje teka, mučnina, smanjenje tjelesne težine, disfonija, sindrom palmarno-plantarne eritrodizestezije (sindrom šaka i stopala), krvarenje, hipotireoza, povraćanje, proteinurija, kašalj i konstipacija.
English: No dose adjustment is required when administering axitinib to patients with mild hepatic impairment (Child-Pugh class A).
Croatian: Nije potrebno prilagođavati dozu kada se aksitinib primjenjuje u bolesnika s blagim oštećenjem jetre (Child-Pugh stadij A).
English: d Fatal (Grade 5) cases were reported.
Croatian: c vidjeti dio Opis odabranih nuspojava d prijavljeni su slučajevi sa smrtnim ishodom (stupanj 5)
English: • If during treatment with this medicine, you get symptoms such as excessive tiredness, swelling of the abdomen, legs or ankles, shortness of breath, or protruding neck veins.
Croatian: • ako tijekom liječenja ovim lijekom dobijete simptome poput prekomjernog umora, oticanja trbuha, nogu ili gležnjeva, kratkoće daha ili izbočenih vratnih žila.
English: Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel.: + 386 (0)1 52 11 400
Croatian: Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel.: 386 (0)1 52 11 400
English: Although axitinib dose adjustment has not been studied in patients receiving strong CYP3A4/5 inhibitors, if a strong CYP3A4/5 inhibitor must be co-administered, a dose decrease of axitinib to approximately half the dose (e.g. the starting dose should be reduced from 5 mg twice daily to 2 mg twice daily) is recommended.
Croatian: Iako nije ispitivana prilagodba doze aksitiniba u bolesnika koji primaju snažne inhibitore CYP3A4/5, ako se mora istodobno primijeniti snažan inhibitor CYP3A4/5, preporučuje se smanjiti dozu aksitiniba na približno polovicu (npr. početnu dozu treba smanjiti s 5 mg dvaput na dan na 2 mg dvaput na dan).
English: In vitro studies of CYP and UGT inhibition and induction In vitro studies indicated that axitinib does not inhibit CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/5, or UGT1A1 at therapeutic plasma concentrations.
Croatian: In vitro ispitivanja inhibicije i indukcije CYP i UGT Ispitivanja in vitro pokazala su da u terapijskim koncentracijama u plazmi aksitinib ne inhibira CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/5 ni UGT1A1.
English: • If during treatment with this medicine, you get symptoms such as headache, confusion, seizures (fits), or changes in vision with or without high blood pressure.
Croatian: • ako tijekom liječenja ovim lijekom dobijete simptome poput glavobolje, smetenosti, napadaja ili promjena vida, uz povišenje krvnog tlaka ili bez njega.
English: In a controlled clinical study with axitinib for the treatment of patients with RCC, one patient inadvertently received a dose of 20 mg twice daily for 4 days and experienced dizziness (Grade 1).
Croatian: U kontroliranom kliničkom ispitivanju aksitiniba u terapiji bolesnika s RCC-om jedan je bolesnik nehotice primao dozu od 20 mg dvaput na dan tijekom 4 dana te je osjetio omaglicu (stupnja 1).
English: • Reduction in the number of blood platelets (cells that help blood to clot) (may show in your blood tests)
Croatian: • smanjen broj krvnih pločica (stanica koje pomažu u zgrušavanju krvi) (može se vidjeti iz rezultata krvnih pretraga)
English: The recommended dose of axitinib is 5 mg twice daily.
Croatian: Doziranje Preporučena doza aksitiniba je 5 mg dvaput na dan.
English: If you stop taking Inlyta
Croatian: Ako prestanete uzimati lijek Inlyta
English: The geometric mean oral clearance and apparent volume of distribution were 38 L/h and 160 L, respectively.
Croatian: Geometrijska sredina klirensa nakon peroralne primjene bila je 38 l/h, a prividnog volumena raspodjele 160 l.
English: Axitinib has not been studied in subjects with severe hepatic impairment (Child-Pugh class C) and should not be used in this population (see section 4.2 for dose adjustment recommendations).
Croatian: Aksitinib nije ispitivan u bolesnika s teškim oštećenjem jetre (Child-Pugh stadij C) i ne smije se primjenjivati u toj populaciji (vidjeti dio 4.2 za preporuke za prilagođavanje doze).
English: HDPE bottle with a silica gel desiccant and a polypropylene closure containing 180 film-coated tablets.
Croatian: HDPE bočica sa sredstvom za sušenje (silika gel) i polipropilenskim čepom, koja sadrži 180 filmom obloženih tableta.
English: In vitro studies in human hepatocytes also indicated that axitinib does not induce CYP1A1, CYP1A2, or CYP3A4/5.
Croatian: Ispitivanja in vitro na ljudskim hepatocitima također su pokazala da aksitinib ne inducira CYP1A1, CYP1A2 i CYP3A4/5.
English: In clinical studies with axitinib, proteinuria, including that of Grade 3 and 4 severity, was reported (see section 4.8).
Croatian: U kliničkim ispitivanjima aksitiniba prijavljena je proteinurija, uključujući i onu stupnja 3 i 4 (vidjeti dio 4.8).
English: In monotherapy studies with axitinib (N = 850), haemoptysis was reported in 3.9% of patients; Grade > 3 haemoptysis was reported in 0.5% of patients.
Croatian: U ispitivanjima aksitiniba u monoterapiji (N = 850) hemoptiza je prijavljena u 3,9% bolesnika; hemoptiza stupnja > 3 prijavljena je u 0,5% bolesnika.
English: A dose decrease is recommended when administering axitinib to patients with moderate hepatic impairment (Child-Pugh class B) (see section 4.2).
Croatian: Preporučuje se smanjiti dozu kad se aksitinib primjenjuje u bolesnika s umjerenim oštećenjem jetre (Child-Pugh stadij B) (vidjeti dio 4.2).
English: If you forget to take Inlyta
Croatian: Ako ste zaboravili uzeti lijek Inlyta
English: Cardiac failure events (see section 4.4)
Croatian: Događaji zatajenja srca (vidjeti dio 4.4)
English: Uncommon Posterior reversible encephalopathy syndromee
Croatian: Sindrom posteriorne reverzibilne encefalopatije (PRES)
English: Ketoconazole, a strong inhibitor of CYP3A4/5, administered at a dose of 400 mg once daily for 7 days, increased the mean area under the curve (AUC) 2-fold and Cmax 1.5-fold of a single 5-mg oral dose of axitinib in healthy volunteers.
Croatian: Ketokonazol, snažan inhibitor CYP3A4/5, primijenjen zdravim dobrovoljcima u dozi od 400 mg jedanput na dan tijekom 7 dana, povećao je prosječno područje ispod krivulje (AUC) 2 puta, a Cmax 1,5 puta nakon jedne doze aksitiniba od 5 mg.
English: The sulfoxide and N-glucuronide metabolites show approximately 400-fold and 8000-fold less in vitro potency, respectively, against VEGFR-2 compared to axitinib.
Croatian: Sulfoksidni metabolit ima približno 400 puta, a N-glukuronid metabolit približno 8.000 puta slabije djelovanje od aksitiniba na VEGFR-2 in vitro.
English: Routine laboratory assessments detected elevated haemoglobin above ULN in 9.7% of patients receiving axitinib.
Croatian: Rutinskim laboratorijskim pretragama povišenje razine hemoglobina iznad GGN otkriveno je u 9,7% bolesnika liječenih aksitinibom.
English: Therefore co-administration of axitinib is not expected to reduce the plasma concentration of co-administered CYP1A1, CYP1A2, or CYP3A4/5 substrates in vivo.
Croatian: Stoga se ne očekuje da će istodobna primjena aksitiniba smanjiti plazmatske koncentracije supstrata CYP1A1, CYP1A2 i CYP3A4/5 in vivo.
English: Axitinib is metabolised primarily in the liver by CYP3A4/5 and to a lesser extent by CYP1A2, CYP2C19, and UGT1A1.
Croatian: Aksitinib se primarno metabolizira u jetri pomoću CYP3A4/5 te u manjoj mjeri pomoću CYP1A2, CYP2C19 i UGT1A1.
English: In vitro studies indicated that axitinib inhibits P-glycoprotein.
Croatian: Ispitivanja in vitro ukazala su na to da aksitinib inhibira P-glikoprotein.
English: In cases of suspected overdose, axitinib should be withheld and supportive care instituted.
Croatian: U slučaju sumnje na predoziranje treba prekinuti uzimanje aksitiniba i uvesti suportivne mjere terapije.