FrancophonIA/ELRC3.0 huggingface dataset:
English: At the 5 mg twice daily dose in the fed state, the geometric mean peak plasma concentration and 24-hour AUC were 27.8 ng/mL and 265 ng.h/mL, respectively, in patients with advanced RCC.
Croatian: Pri dozi od 5 mg dvaput na dan primijenjenoj uz obrok u bolesnika s uznapredovalim RCC-om geometrijska sredina vršne koncentracije u plazmi iznosila je 27,8 ng/ml, a 24-satnog AUC-a 265 ng.h/ml.
English: The haemorrhagic adverse reactions in patients treated with axitinib included epistaxis (7.8%), haematuria (3.6%), haemoptysis (2.5%), rectal haemorrhage (2.2%), gingival bleeding (1.1%), gastric haemorrhage (0.6%), cerebral haemorrhage (0.3%) and lower gastrointestinal haemorrhage (0.3%).
Croatian: Krvarenja u bolesnika liječenih aksitinibom uključivala su epistaksu (7,8%), hematuriju (3,6%), hemoptizu (2,5%), rektalno krvarenje (2,2%), krvarenje gingive (1,1%), krvarenje u želucu (0,6%), krvarenje u mozgu (0,3%) i krvarenje u donjem dijelu probavnog trakta (0,3%).
English: Axitinib has not been studied in patients with severe hepatic impairment (Child-Pugh class C) and should not be used in this population (see sections 4.4 and 5.2).
Croatian: Aksitinib nije ispitivan u bolesnika s teškim oštećenjem jetre (Child-Pugh stadij C) i ne smije se primjenjivati u toj populaciji (vidjeti dijelove 4.4 i 5.2).
English: d Cutoff date: 01 November 2011.
Croatian: Podaci prikupljeni do: 1. studenog 2011.
English: Tell your doctor if you experience excessive tiredness, swelling of the abdomen, legs, or ankles, shortness of breath, or protruding neck veins.
Croatian: Obavijestite liječnika ako primijetite prekomjerni umor, oticanje trbuha, nogu ili gležnjeva, kratkoću daha ili izbočene vratne žile.
English: What you need to know before you take Inlyta Do not take Inlyta:
Croatian: "Što trebate znati prije nego počnete uzimati lijek Inlyta"):
English: If axitinib is interrupted, patients receiving antihypertensive medicinal products should be monitored for hypotension (see section 4.2).
Croatian: Kod privremenog prekida terapije aksitinibom bolesnike koji uzimaju antihipertenzive treba nadzirati zbog moguće hipotenzije (vidjeti dio 4.2).
English: In clinical studies with axitinib for the treatment of patients with RCC, patients with serum creatinine > 1.5 times the ULN or calculated creatinine clearance < 60 mL/min were excluded.
Croatian: U klinička ispitivanja aksitiniba u terapiji bolesnika s RCC-om nisu uključivani bolesnici s vrijednostima serumskog kreatinina > 1,5 puta iznad GGN ili izračunatim klirensom kreatinina < 60 ml/min.
English: Post-marketing adverse reactions identified in clinical studies are also included.
Croatian: Nuspojave zabilježene u kliničkim ispitivanjima nakon stavljanja lijeka u promet također su uključene u Tablicu 1.
English: HDPE bottle with a silica gel desiccant and a polypropylene closure containing 60 film-coated tablets.
Croatian: HDPE bočica sa sredstvom za sušenje (silika gel) i polipropilenskim čepom, koja sadrži 60 filmom obloženih tableta.
English: • If you have liver problems.
Croatian: • ako imate tegoba s jetrom.
English: In a controlled clinical study with axitinib for the treatment of patients with RCC, 34% of patients treated with axitinib were ≥ 65 years of age.
Croatian: U kontroliranim kliničkim ispitivanjima aksitiniba u terapiji bolesnika s RCC-om, 34% bolesnika liječenih aksitinibom bilo je u dobi od ≥ 65 godina.
English: Partially reversible dental caries were observed in mice treated for more than 1 month at exposure levels similar to the expected human exposure.
Croatian: Djelomično reverzibilan zubni karijes opažen je u miševa koji su primali aksitinib više od mjesec dana, pri razinama izloženosti sličnima očekivanoj izloženosti ljudi.
English: In a randomised, 2-way crossover study, 35 healthy subjects were administered a single oral dose of axitinib (5 mg) in the absence and presence of 400 mg ketoconazole for 7 days.
Croatian: U randomiziranom, dvosmjerno ukriženom kliničkom ispitivanju 35 zdravih ispitanika primilo je jednu peroralnu dozu aksitiniba (5 mg), a da pritom tijekom 7 dana jesu ili nisu istodobno primali ketokonazol u dozi od 400 mg.
English: Get emergency help right away and call your doctor if you get symptoms such as chest pain or pressure; pain in your arms, back, neck or jaw; shortness of breath; numbness or weakness on one side of your body; trouble talking; headache; vision changes: or dizziness.
Croatian: Odmah zatražite hitnu medicinsku pomoć i pozovite svog liječnika ako nastupe simptomi kao što su bol ili stezanje u prsima, bolovi u rukama, leđima, vratu ili čeljusti, nedostatak daha, obamrlost ili slabost na jednoj strani tijela, poteškoće s govorom, glavobolja, promjene vida ili omaglica.
English: Your doctor should monitor for signs or symptoms of heart failure events periodically throughout treatment with axitinib.
Croatian: Liječnik mora pratiti znakove ili simptome događaja zatajenja srca povremeno tijekom terapije aksitinibom.
English: Axitinib has not been studied in patients with severe hepatic impairment (Child-Pugh class C) and should not be used in this population.
Croatian: Aksitinib nije ispitivan u bolesnika s teškim oštećenjem jetre (Child-Pugh stadij C) i ne smije se primjenjivati u toj populaciji.
English: In clinical studies with axitinib, the systemic exposure to axitinib was approximately two-fold higher in subjects with moderate hepatic impairment (Child-Pugh class B) compared to subjects with normal hepatic function.
Croatian: U kliničkim ispitivanjima aksitiniba sistemska izloženost aksitinibu u ispitanika s umjerenim oštećenjem jetre (Child-Pugh stadij B) bila je približno dvaput veća nego u ispitanika s normalnom funkcijom jetre.
English: In vitro studies also indicated that axitinib has the potential to inhibit CYP2C8.
Croatian: Ispitivanja in vitro pokazala su i da aksitinib može inhibirati CYP2C8.
English: Hyperthyroidism was reported in 1.6% of patients receiving axitinib.
Croatian: Hipertireoza je prijavljena u 1,6% bolesnika koji su primali aksitinib.
English: Management of some adverse reactions may require temporary or permanent discontinuation of axitinib therapy (see section 4.4).
Croatian: Zbrinjavanje nekih nuspojava može zahtijevati privremen ili trajan prekid primjene aksitiniba (vidjeti dio 4.4).
English: f Including cardiac failure, cardiac failure congestive, cardiopulmonary failure, ejection fraction decreased, left ventricular dysfunction and right ventricular failure.
Croatian: e uključujući leukoencefalopatiju uključujući zatajenje srca, kongestivno zatajenje srca, kardiopulmonalno zatajenje, smanjenje ejekcijske frakcije, poremećaj funkcije lijeve klijetke i zatajenje desne klijetke.
English: A significant increase in polyploidy was observed in vitro at concentrations > 0.22 µg/mL, and an elevation in micronucleated polychromatic erythrocytes was observed in vivo with No Observed Effect Level (NOEL) 69-fold the expected human exposure.
Croatian: Opažen je značajan porast poliploidije in vitro, pri koncentracijama od > 0,22 µg/ml, dok je in vivo opažen porast broja mikronukleusnih polikromatskih eritrocita.
English: Elevation of haemoglobin or haematocrit
Croatian: Povišene razine hemoglobina i hematokrita
English: • The active substance is axitinib.
Croatian: Djelatna tvar je aksitinib.
English: Kaplan-Meier curve of progression-free survival by independent assessment for the overall population
Croatian: Slika 1: Kaplan-Meierova krivulja preživljenja bez progresije bolesti prema neovisnoj procjeni za ukupnu populaciju
English: How to take Inlyta
Croatian: Kako uzimati lijek Inlyta
English: In a controlled clinical study with axitinib for the treatment of patients with RCC, liver-related adverse reactions were reported.
Croatian: U kontroliranom kliničkom ispitivanju aksitiniba u terapiji bolesnika s RCC-om prijavljene su jetrene nuspojave.
English: In monotherapy studies with axitinib (N = 850), arterial embolic and thrombotic adverse reactions (including transient ischemic attack, myocardial infarction, and cerebrovascular accident) were reported in 5.3% of patients receiving axitinib.
Croatian: U ispitivanjima aksitiniba u monoterapiji (N = 850) arterijski embolijski i trombotski događaji (uključujući prolaznu ishemijsku ataku, infarkt miokarda i cerebrovaskularni incident) prijavljeni su u 5,3% bolesnika koji su primali aksitinib.
English: Thyroid stimulating hormone (TSH) increased was reported as an adverse reaction in 5.3% of patients receiving axitinib.
Croatian: Povišene razine hormona koji stimulira štitnjaču (TSH) prijavljene su kao nuspojava u 5,3% bolesnika koji su primali aksitinib.
English: Management of some adverse reactions may require temporary or permanent discontinuation and/or dose reduction of axitinib therapy (see section 4.4).
Croatian: Zbrinjavanje nekih nuspojava može zahtijevati privremen ili trajan prekid primjene i/ili smanjenje doze aksitiniba (vidjeti dio 4.4).
English: Reversible physeal dysplasia was observed in mice and dogs given axitinib for at least 1 month at exposure levels approximately six-fold higher than the expected human exposure.
Croatian: Reverzibilna fizalna displazija zabilježena je u miševa i pasa koji su primali aksitinib najmanje mjesec dana, pri razinama izloženosti oko 6 puta većima od očekivane izloženosti u ljudi.
English: See section 4.
Croatian: PRILOG IV.
English: • Fistula (abnormal tube like passage from one normal body cavity to another body cavity or the skin)
Croatian: • fistula (neuobičajen spoj u obliku cjevčice između dviju tjelesnih šupljina ili između neke tjelesne šupljine i kože)
English: c One-sided p-value from a log-rank test of treatment stratified by ECOG performance status and prior therapy.
Croatian: Jednostrana p-vrijednost iz log-rang testa terapije stratificiranog prema ECOG statusu i prethodnoj terapiji.
English: Kaplan-Meier curve of progression-free survival by independent assessment for the prior sunitinib subgroup
Croatian: Slika 2: Kaplan-Meierova krivulja preživljenja bez progresije bolesti prema neovisnoj procjeni za podskupinu prethodno liječenu sunitinibom
English: Get emergency help right away and call your doctor if you get symptoms such as chest pain or pressure; pain in your arms, back, neck or jaw; shortness of breath; numbness or weakness on one side of your body; trouble talking; headache; vision changes; or dizziness while on treatment with this medicine.
Croatian: Odmah zatražite hitnu medicinsku pomoć i pozovite svog liječnika ako tijekom liječenja ovim lijekom nastupe simptomi kao što su bol ili stezanje u prsima, bolovi u rukama, leđima, vratu ili čeljusti, nedostatak daha, obamrlost ili slabost na jednoj strani tijela, poteškoće s govorom, glavobolja, promjene vida ili omaglica.
English: Fatal pulmonary embolism was reported in one patient (0.3%) receiving axitinib.
Croatian: Smrtonosna plućna embolija prijavljena je u jednog bolesnika (0,3%) liječenog aksitinibom.
English: In monotherapy studies with axitinib (N = 672) for the treatment of patients with RCC, cardiac failure events (including cardiac failure, cardiac failure congestive, cardiopulmonary failure, left ventricular dysfunction, ejection fraction decreased, and right ventricular failure) were reported in 1.8% patients receiving axitinib.
Croatian: U ispitivanjima aksitiniba u monoterapiji (N = 672) u terapiji bolesnika s RCC-om, događaji zatajenja srca (uključujući zatajenje srca, kongestivno zatajenje srca, kardiopulmonalno zatajenje, poremećaj funkcije lijeve klijetke, smanjenje ejekcijske frakcije i zatajenje desne klijetke) prijavljeni su u 1,8% bolesnika koji su primali aksitinib.
English: A risk ratio > 1 indicated a higher likelihood of responding in the axitinib arm; a risk ratio < 1 indicated a higher likelihood of responding in the sorafenib arm. g One-sided p-value from Cochran-Mantel-Haenszel test of treatment stratified by ECOG performance status and prior therapy.
Croatian: Omjer rizika > 1 ukazuje na veću vjerojatnost odgovora u skupini liječenoj aksitinibom; omjer rizika < 1 ukazuje na veću vjerojatnost odgovora u skupini liječenoj sorafenibom.
English: In a controlled clinical study with axitinib for the treatment of patients with RCC, hypothyroidism was reported in 20.9% of patients and hyperthyroidism was reported in 1.1% of patients.
Croatian: U kontroliranom kliničkom ispitivanju aksitiniba u terapiji bolesnika s RCC-om hipotireoza je prijavljena u 20,9%, a hipertireoza u 1,1% bolesnika.
English: Pregnant mice exposed to axitinib showed an increased occurrence of cleft palate malformations and skeletal variations, including delayed ossification, at exposure levels below the expected human exposure.
Croatian: Nakon izlaganja skotnih ženki miševa aksitinibu zabilježena je povećana učestalost rascjepa nepca i koštanih varijacija, uključujući kasnije okoštavanje, pri razinama izloženosti manjima od očekivane izloženosti u ljudi.
English: In clinical studies with axitinib for the treatment of patients with RCC, events of hypothyroidism and, to a lesser extent, hyperthyroidism, were reported (see section 4.8).
Croatian: U kliničkim ispitivanjima aksitiniba u terapiji bolesnika s RCC-om prijavljeni su hipotireoza i, u manjoj mjeri, hipertireoza (vidjeti dio 4.8).
English: • Swelling of the abdomen, legs, or ankles, protruding neck veins, excessive tiredness,
Croatian: • oticanje trbuha, nogu ili gležnjeva, izbočene vratne žile, prekomjerni umor, kratkoća daha
English: i Including Budd-Chiari syndrome, deep vein thrombosis, jugular vein thrombosis, pelvic venous thrombosis, pulmonary embolism, retinal vein occlusion, retinal vein thrombosis, subclavian vein thrombosis, venous thrombosis, and venous thrombosis limb.
Croatian: uključujući Budd-Chiarijev sindrom, duboku vensku trombozu, trombozu vratne vene, vensku trombozu zdjelice, plućnu emboliju, okluziju mrežnične vene, trombozu mrežnične vene, trombozu vene subklavije, vensku trombozu i vensku trombozu uda.
English: Grade 3/4 cardiac failure events were reported in 1.0% patients and fatal cardiac failure events were reported in 0.3% patients receiving axitinib.
Croatian: Događaji zatajenja srca stupnja 3/4 prijavljeni su u 1,0% bolesnika, a smrtonosni događaji zatajenja srca prijavljeni su u 0,3% bolesnika koji su primali aksitinib.
English: Findings in females included signs of delayed sexual maturity, reduced or absent corpora lutea, decreased uterine weights and uterine atrophy at exposures approximately equivalent to the expected human exposure.
Croatian: Nalazi u ženki uključuju znakove kasnijeg spolnog sazrijevanja, smanjenje ili nedostatak žutog tijela, smanjenu težinu maternice i atrofiju maternice pri razinama izloženosti približno jednakima očekivanoj izloženosti u ljudi.
English: In vitro studies indicated that axitinib has a potential to inhibit CYP1A2.
Croatian: Ispitivanja in vitro pokazala su da aksitinib može inhibirati CYP1A2.
English: Increases in haemoglobin or haematocrit, reflective of increases in red blood cell mass, may occur during treatment with axitinib (see section 4.8, polycythaemia).
Croatian: Tijekom terapije aksitinibom može doći do povišenja razine hemoglobina ili hematokrita, što upućuje na povećanu masu crvenih krvnih stanica (vidjeti dio 4.8, policitemija).
English: In vitro data indicate that axitinib is metabolised primarily by CYP3A4/5 and, to a lesser extent, CYP1A2, CYP2C19, and uridine diphosphate-glucuronosyltransferase (UGT) 1A1.
Croatian: Podaci dobiveni in vitro pokazuju da se aksitinib metabolizira prvenstveno putem CYP3A4/5 te u manjoj mjeri putem CYP1A2, CYP2C19 i uridin-difosfat-glukuronoziltransferaze (UGT) 1A1.
English: Co-administration of axitinib with strong CYP3A4/5 inhibitors may increase axitinib plasma concentrations (see section 4.5).
Croatian: Istodobna primjena aksitiniba sa snažnim inhibitorima CYP3A4/5 može povećati koncentracije aksitiniba u plazmi (vidjeti dio 4.5).
English: Patients who tolerate the axitinib starting dose of 5 mg twice daily with no adverse reactions > Grade 2 (i.e. without severe adverse reactions according to the Common Terminology Criteria for Adverse Events [CTCAE] version 3.0) for two consecutive weeks may have their dose increased to 7 mg twice daily unless the patient's blood pressure is > 150/90 mmHg or the patient is receiving antihypertensive treatment.
Croatian: Common Terminology Criteria for Adverse Events, CTCAE], verzija 3.0) tijekom dva uzastopna tjedna, doza se može povećati na 7 mg dvaput na dan ako im krvni tlak nije > 150/90 mmHg ili se ne liječe antihipertenzivima.
English: h One-sided p-value from a log-rank test of treatment stratified by ECOG performance status.
Croatian: Jednostrana p-vrijednost iz log-rang testa terapije stratificiranog prema ECOG statusu.
English: Co-administration of axitinib with strong CYP3A4/5 inducers may decrease axitinib plasma concentrations (see section 4.5).
Croatian: Istodobna primjena aksitiniba sa snažnim induktorima CYP3A4/5 može smanjiti koncentracije aksitiniba u plazmi (vidjeti dio 4.5).
English: • Diarrhoea, feeling or being sick (nausea or vomiting), stomach ache, indigestion, soreness of the mouth, tongue or throat, constipation
Croatian: • proljev, mučnina ili povraćanje, bol u trbuhu, probavne tegobe, bol u ustima, jeziku ili grlu,
English: Axitinib has not been studied in patients < 18 years of age.
Croatian: Pedijatrijska populacija Aksitinib nije ispitivan u bolesnika mlađih od 18 godina.
English: Tell your doctor if you have severe abdominal pain while on treatment with this medicine.
Croatian: Obavijestite svog liječnika ako tijekom liječenja ovim lijekom imate jake bolove u trbuhu.
English: Overall ITT
Croatian: Ukupna ITT populacija
English: Co-administration of axitinib with strong CYP3A4/5 inducers (e.g. rifampicin, dexamethasone, phenytoin, carbamazepine, rifabutin, rifapentin, phenobarbital, and Hypericum perforatum [St.
Croatian: Istodobna primjena aksitiniba sa snažnim induktorima CYP3A4/5 (npr. rifampicinom, deksametazonom, fenitoinom, karbamazepinom, rifabutinom, rifapentinom, fenobarbitalom i Hypericum perforatum [gospinom travom]) može smanjiti koncentracije aksitiniba u plazmi.
English: Inlyta 1 mg film-coated tablets Inlyta 3 mg film-coated tablets Inlyta 5 mg film-coated tablets Inlyta 7 mg film-coated tablets
Croatian: Inlyta 1 mg filmom obložene tablete Inlyta 3 mg filmom obložene tablete Inlyta 5 mg filmom obložene tablete Inlyta 7 mg filmom obložene tablete
English: Median OS d in months (95% CI)
Croatian: (95% CI) Medijan OS-a d u mjesecima
English: Get emergency help right away and call your doctor if you get symptoms such as headache, confusion, seizures (fits), or changes in vision with or without high blood pressure.
Croatian: Odmah potražite hitnu medicinsku pomoć ako dobijete simptome poput glavobolje, smetenosti, napadaja ili promjena vida, uz povišenje krvnog tlaka ili bez njega.
English: • Hole in the stomach or intestine or formation of fistula (abnormal tube-like passage from one normal body cavity to another body cavity or the skin).
Croatian: • Puknuće stijenke želuca ili crijeva ili stvaranje fistula (neuobičajenih spojeva u obliku cjevčice između dviju tjelesnih šupljina ili između neke tjelesne šupljine i kože).
English: shortness of breath (signs of heart failure events)
Croatian: (znakovi događaja zatajenja srca
English: INFORMATION IN BRAILLE Inlyta 1 mg
Croatian: Inlyta 1 mg
English: In clinical studies with axitinib, venous embolic and thrombotic events (including pulmonary embolism, deep vein thrombosis, and retinal vein occlusion/thrombosis) were reported (see section 4.8).
Croatian: U kliničkim ispitivanjima aksitiniba prijavljeni su venski embolijski i trombotski događaji (uključujući plućnu emboliju, duboku vensku trombozu i okluziju/trombozu mrežnične vene) (vidjeti dio 4.8).
English: Patients should be advised that they may experience events such as dizziness and/or fatigue during treatment with axitinib.
Croatian: Bolesnike treba upozoriti da tijekom terapije aksitinibom mogu osjetiti omaglicu i/ili umor.
English: Inlyta 1 mg film-coated tablets Inlyta 3 mg film-coated tablets Inlyta 5 mg film-coated tablets Inlyta 7 mg film-coated tablets axitinib
Croatian: Inlyta 1 mg filmom obložene tablete Inlyta 3 mg filmom obložene tablete Inlyta 5 mg filmom obložene tablete Inlyta 7 mg filmom obložene tablete aksitinib
English: Unchanged axitinib is not detected in the urine.
Croatian: U mokraći nije detektiran nepromijenjen aksitinib.
English: Fatal haemorrhage was reported in one patient (0.3%) receiving axitinib (gastric haemorrhage).
Croatian: Smrtonosno krvarenje prijavljeno je u jednog bolesnika (0,3%) liječenog aksitinibom (radilo se o želučanom krvarenju).
English: In clinical studies with axitinib for the treatment of patients with RCC, hypertension was very commonly reported (see section 4.8).
Croatian: U kliničkim ispitivanjima aksitiniba u terapiji bolesnika s RCC-om hipertenzija je prijavljena vrlo često (vidjeti dio 4.8).
English: Haemorrhage (see section 4.4)
Croatian: Krvarenje (vidjeti dio 4.4)
English: In a controlled clinical study with axitinib (N = 359) for the treatment of patients with RCC, cardiac failure events were reported in 1.7 % patients receiving axitinib, including cardiac failure (0.6%), cardiopulmonary failure (0.6%), left ventricular dysfunction (0.3%), and right ventricular failure
Croatian: U kontroliranom kliničkom ispitivanju aksitiniba (N = 359) u terapiji bolesnika s RCC-om prijavljeni su događaji zatajenja srca u 1,7% bolesnika koji su primali aksitinib, uključujući zatajenje srca (0,6%), kardiopulmonalno zatajenje (0,6%), poremećaj funkcije lijeve klijetke (0,3%) i zatajenje desne klijetke
English: Oropharyngeal pain
Croatian: • upala žučnog mjehura
English: In clinical studies with axitinib, arterial embolic and thrombotic events (including transient ischemic attack, myocardial infarction, cerebrovascular accident and retinal artery occlusion) were reported (see section 4.8).
Croatian: U kliničkim ispitivanjima aksitiniba prijavljeni su arterijski embolijski i trombotski događaji (uključujući prolaznu ishemijsku ataku, infarkt miokarda, cerebrovaskularni incident i okluziju mrežnične arterije) (vidjeti dio 4.8).
English: In a controlled clinical study with axitinib for the treatment of patients with RCC that excluded patients with untreated brain metastasis, haemorrhagic adverse reactions were reported in 21.4% of patients receiving axitinib.
Croatian: U kontroliranom kliničkom ispitivanju aksitiniba u terapiji bolesnika s RCC-om u koje nisu bili uključeni bolesnici s neliječenim metastazama u mozgu krvarenje kao nuspojava prijavljeno je u 21,4% bolesnika koji su primali aksitinib.
English: Cardiac failure events
Croatian: Događaji zatajenja srca
English: Grade > 3 haemorrhagic adverse reactions were reported in 3.1% of patients receiving axitinib (including cerebral haemorrhage, gastric haemorrhage, lower gastrointestinal haemorrhage and haemoptysis).
Croatian: Epizode krvarenja stupnja > 3 prijavljene su u 3,1% bolesnika koji su primali aksitinib (uključujući krvarenja u mozgu, želucu, donjem dijelu probavnog sustava i hemoptizu).
English: How to store Inlyta
Croatian: Kako čuvati lijek Inlyta
English: Signs or symptoms of cardiac failure should periodically be monitored throughout treatment with axitinib.
Croatian: Znakove ili simptome zatajenja srca mora se povremeno pratiti tijekom terapije aksitinibom.
English: If a strong CYP3A4/5 inducer must be co-administered, a dose adjustment of axitinib is recommended (see section 4.2).
Croatian: Mora li se istodobno primijeniti snažan induktor CYP3A4/5, preporučuje se prilagoditi dozu aksitiniba (vidjeti dio 4.2).
English: Caution should be exercised due to the risk of increased axitinib plasma concentrations in patients taking strong inhibitors of these isozymes.
Croatian: U bolesnika koji uzimaju snažne inhibitore tih izoenzima potreban je oprez zbog opasnosti od povećanja koncentracija aksitiniba u plazmi.
English: INFORMATION IN BRAILLE Inlyta 7 mg
Croatian: Inlyta 7 mg
English: Grade 3 venous embolic and thrombotic events were reported in 0.9% of patients.
Croatian: Venski embolijski i trombotski događaji stupnja 3 prijavljeni su u 0,9% bolesnika.