FrancophonIA/ELRC3.0 huggingface dataset:
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim ažuriranim verzijama RMP-a.
English: Based on non-clinical findings, axitinib has the potential to impair reproductive function and fertility in humans (see section 5.3).
Croatian: Na temelju nekliničkih nalaza aksitinib može štetno djelovati na reproduktivnu funkciju i plodnost u ljudi (vidjeti dio 5.3).
English: United Kingdom Pfizer Limited Tel: +44 (0) 1304 616161
Croatian: Velika Britanija Pfizer Limited Tel: +44 (0) 1304 616161
English: Inlyta may increase side effects associated with theophylline, used to treat asthma or other lung diseases.
Croatian: Inlyta može pojačati nuspojave koje se povezuju s teofilinom, lijekom koji se koristi za liječenje astme ili drugih plućnih bolesti.
English: In case of severe or persistent arterial hypertension and symptoms suggestive of posterior reversible encephalopathy syndrome (PRES) (see below), a diagnostic brain magnetic resonance image (MRI) should be considered.
Croatian: U slučaju teške ili perzistentne arterijske hipertenzije i simptoma koji upućuju na sindrom posteriorne reverzibilne encefalopatije (engl. posterior reversible encephalopathy syndrome, PRES) (vidjeti u daljnjem tekstu) treba razmotriti dijagnostičko snimanje mozga magnetskom rezonancijom.
English: There are no data regarding the use of axitinib in pregnant women.
Croatian: Nema podataka o primjeni aksitiniba u trudnica.
English: The baseline demographic and disease characteristics were similar between the axitinib and sorafenib groups with regard to age, gender, race, Eastern Cooperative Oncology Group (ECOG) performance status, geographic region, and prior treatment.
Croatian: Osnovna demografska obilježja kao i obilježja bolesti u skupinama liječenima aksitinibom i sorafenibom bila su slična s obzirom na dob, spol, rasu, ECOG (Eastern Cooperative Oncology Group) status, geografsko područje i prethodnu terapiju.
English: Uncommon: may affect up to 1 in 100 people • Reduction in the number of white blood cells (may show in your blood tests)
Croatian: Manje često: (mogu se javiti u do 1 na 100 osoba): smanjen broj bijelih krvnih stanica (može se vidjeti iz rezultata krvnih pretraga)
English: However, axitinib is not expected to inhibit P-glycoprotein at therapeutic plasma concentrations.
Croatian: Ipak, ne očekuje se da će aksitinib inhibirati P-glikoprotein pri terapijskim koncentracijama u plazmi.
English: For patients who develop severe hypertension, temporarily interrupt axitinib and restart at a lower dose once the patient is normotensive.
Croatian: U bolesnika u kojih se razvije teška hipertenzija treba privremeno prekinuti primjenu aksitiniba i ponovno ga uvesti u nižoj dozi kad bolesnik postane normotenzivan.
English: On the basis of the scientific conclusions for axitinib the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing axitinib is unchanged subject to the proposed changes to the product information.
Croatian: Na temelju znanstvenih zaključaka za aksitinib, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) aksitinib nepromijenjen, uz predložene izmjene informacija o lijeku.
English: Subsequently, using the same criteria, patients who tolerate an axitinib dose of 7 mg twice daily may have their dose increased to a maximum of 10 mg twice daily.
Croatian: Nakon toga se, prema istim kriterijima, bolesnicima koji podnose dozu aksitiniba od 7 mg dvaput na dan doza može povećati do najviše 10 mg dvaput na dan.
English: Based on the pharmacological properties of axitinib, it may cause foetal harm when administered to a pregnant woman.
Croatian: S obzirom na svoja farmakološka svojstva, aksitinib može štetno djelovati na plod kad se primjenjuje u trudnica.
English: • If during treatment with this medicine you get severe stomach (abdominal) pain or stomach pain that does not go away.
Croatian: • ako tijekom liječenja ovim lijekom dobijete jake bolove u trbuhu (abdomenu) ili bol u trbuhu ne prolazi.
English: Axitinib has minor influence on the ability to drive and use machines.
Croatian: Aksitinib malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: In a controlled clinical study, the median onset time for hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg) was within the first month of the start of axitinib treatment and blood pressure increases have been observed as early as 4 days after starting axitinib.
Croatian: U kontroliranom kliničkom ispitivanju medijan vremena nastupa hipertenzije (sistolički krvni tlak > 150 mmHg ili dijastolički krvni tlak > 100 mmHg) bio je u prvih mjesec dana od početka terapije aksitinibom, a povišenje krvnog tlaka uočeno je već 4 dana nakon početka terapije.
English: Hypersensitivity to axitinib or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na aksitinib ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: No dosage adjustment is required on the basis of patient age or race (see sections 4.2 and 5.2).
Croatian: Nije potrebno prilagođavati dozu s obzirom na dob ili rasu bolesnika (vidjeti dijelove 4.2 i 5.2).
English: e Cutoff date: 31 August 2010.
Croatian: Podaci prikupljeni do: 31. kolovoza 2010.
English: A fatal acute myocardial infarction and cerebrovascular accident was reported in one patient each (0.3%).
Croatian: Akutni infarkt miokarda i cerebrovaskularni incident sa smrtnim ishodom prijavljen je u jednog bolesnika svaki (0,3%).
English: • Lack of energy, feeling weak or tired
Croatian: • nedostatak energije, slabost ili umor
English: Based on the short half-life of axitinib, steady state is expected within 2 to 3 days of the initial dose.
Croatian: S obzirom na kratak poluvijek aksitiniba očekuje se da će se stanje dinamičke ravnoteže postići nakon 2 do 3 dana od početne doze.
English: • Heart failure events.
Croatian: • događaji zatajenja srca.
English: If haemoglobin or haematocrit becomes elevated above the normal level, patients should be treated according to standard medical practice to decrease haemoglobin or haematocrit to an acceptable level.
Croatian: Ako se hemoglobin ili hematokrit povise iznad normalne razine, bolesnika treba liječiti sukladno standardnoj medicinskoj praksi kako bi se vrijednosti hemoglobina odnosno hematokrita snizile na prihvatljivu razinu.
English: • Joint pain, pain in hands or feet
Croatian: • bolovi u zglobovima, bolovi u šakama ili stopalima
English: Magnetic resonance imaging is necessary to confirm the diagnosis of PRES.
Croatian: Za potvrdu dijagnoze PRES-a potrebno je snimanje magnetskom rezonancijom.
English: Results of this study indicated that axitinib plasma exposures up to two-fold greater than therapeutic levels expected following a 5 mg dose, did not produce clinically-significant QT interval prolongation.
Croatian: Rezultati ovog ispitivanja pokazali su da gotovo dvostruko veća izloženost aksitiniba u plazmi od terapijske, koja se očekuje nakon doze od 5 mg, nije proizvela klinički značajno produljenje QT-intervala.
English: The adverse reactions are listed by system organ class, frequency category and grade of severity.
Croatian: Nuspojave su popisane prema organskim sustavima, kategoriji učestalosti i stupnju ozbiljnosti.
English: Within each system organ class, adverse reactions with the same frequency are presented in order of decreasing seriousness.
Croatian: Unutar svakog organskog sustava nuspojave jednake učestalosti navedene su u padajućem nizu prema ozbiljnosti.
English: When dose reduction is necessary, the axitinib dose may be reduced to 3 mg twice daily and further to 2 mg twice daily.
Croatian: Kada je potrebno smanjenje doze, doza aksitiniba se može smanjiti na 3 mg dvaput na dan te zatim na 2 mg dvaput na dan.
English: Axitinib has not been studied in patients who have evidence of untreated brain metastasis or recent active gastrointestinal bleeding, and should not be used in those patients.
Croatian: Aksitinib nije ispitivan u bolesnika sa znakovima neliječenih metastaza u mozgu ili nedavnog aktivnog gastrointestinalnog krvarenja te se ne smije primjenjivati u tih bolesnika.
English: • clarithromycin, erythromycin or telithromycin, antibiotics used to treat bacterial infections;
Croatian: • klaritromicin, eritromicin ili telitromicin, antibiotici koji se koriste za liječenje bakterijskih infekcija,
English: In the overall patient population and the two main subgroups (prior sunitinib treatment and prior cytokine treatment), there was a statistically significant advantage for axitinib over sorafenib for the primary endpoint of PFS (see Table 2 and Figures 1, 2 and 3).
Croatian: U ukupnoj populaciji bolesnika i u dvije glavne podskupine (prethodno liječeni sunitinibom i prethodno liječeni citokinom) utvrđena je statistički značajna prednost terapije aksitinibom u odnosu na sorafenib za primarnu mjeru ishoda, PFS (vidjeti Tablicu 2. i Slike 1., 2. i 3.).
English: Population pharmacokinetic analyses in patients with advanced cancer (including advanced RCC) and healthy volunteers indicate that there are no clinically relevant effects of age, gender, body weight, race, renal function, UGT1A1 genotype, or CYP2C19 genotype.
Croatian: Analize populacijske farmakokinetike u bolesnika s uznapredovalim rakom (uključujući uznapredovali RCC) i zdravih dobrovoljaca pokazuju da dob, spol, tjelesna težina, rasa, bubrežna funkcija, UGT1A1 genotip i CYP2C19 genotip nemaju klinički značajnog utjecaja.
English: Tablet film-coating Hypromellose 2910 (15 mPa·s) Titanium dioxide (E171) Lactose monohydrate Triacetin (E1518) Iron oxide red (E172)
Croatian: Film ovojnica tablete Hipromeloza 2910 (15 mPa s) titanijev dioksid (E171) laktoza hidrat triacetin (E1518) željezov oksid, crveni (E172)
English: Efficacy results Endpoint / study population axitinib sorafenib HR (95% CI) p-value
Croatian: Mjera ishoda / ispitivana populacija aksitinib sorafenib HR (95% CI)
English: Axitinib should be used with caution in patients who are at risk for, or who have a history of, these events.
Croatian: Aksitinib treba primjenjivati uz oprez u bolesnika koji su pod rizikom za te događaje ili ih imaju u anamnezi.
English: ORR b,e % (95% CI)
Croatian: % (95% CI)
English: Adverse reactions reported in RCC studies in patients who received axitinib (N = 672)
Croatian: Nuspojave prijavljene u ispitivanjima RCC-a u bolesnika koji su primali aksitinib (N = 672)
English: Inlyta is a medicine containing the active substance axitinib.
Croatian: Inlyta je lijek koji sadrži djelatnu tvar aksitinib.
English: In vitro studies with P-glycoprotein
Croatian: In vitro ispitivanja s P-glikoproteinom
English: In plasma, the N-glucuronide metabolite represented the predominant radioactive component (50% of circulating radioactivity) and unchanged axitinib and the sulfoxide metabolite each accounted for approximately 20% of the circulating radioactivity.
Croatian: U plazmi je pretežita komponenta radioaktivnosti bio N-glukuronid metabolit (predstavljao je 50% radioaktivnosti u cirkulaciji), dok su nepromijenjeni aksitinib i sulfoksidni metabolit svaki činili 20% radioaktivnosti u cirkulaciji.
English: After oral administration of axitinib tablets, the mean absolute bioavailability is 58% compared to intravenous administration.
Croatian: Nakon peroralne primjene tableta aksitiniba prosječna apsolutna bioraspoloživost je 58% u odnosu na intravensku primjenu.
English: However, co-administration of axitinib with paclitaxel, a known CYP2C8 substrate, did not result in increased plasma concentrations of paclitaxel in patients with advanced cancer, indicating lack of clinical CYP2C8 inhibition.
Croatian: Ipak, istodobna primjena aksitiniba s paklitakselom, poznatim supstratom CYP2C8, nije izazvala povećanje plazmatskih koncentracija paklitaksela u bolesnika s uznapredovalim rakom, što upućuje na izostanak inhibicije CYP2C8 u kliničkim uvjetima.
English: Median PFS a,b in months (95% CI)
Croatian: Medijan PFS-a a, b u mjesecima
English: You must immediately contact your doctor if you experience any of those following serious side effects (see also section 2 “What you need to know before you take Inlyta”):
Croatian: Morate odmah kontaktirati svog liječnika ako nastupi bilo koja od ovih ozbiljnih nuspojava (pogledajte i dio 2.
English: Hypothyroidism or hyperthyroidism should be treated according to standard medical practice to maintain euthyroid state.
Croatian: Hipotireozu odnosno hipertireozu treba liječiti sukladno standardnoj medicinskoj praksi kako bi se održala eutireoza.
English: Following oral administration of a 5 mg radioactive dose of axitinib, 30-60% of the radioactivity was recovered in faeces and 23% of the radioactivity was recovered in urine.
Croatian: Nakon peroralne primjene radioaktivno označene doze aksitiniba od 5 mg 30-60% radioaktivnosti pronađeno je u fecesu, a 23% radioaktivnosti u mokraći.
English: Inlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.
Croatian: Inlyta je indicirana za liječenje odraslih bolesnika s uznapredovalim karcinomom bubrežnih stanica (engl. renal cell carcinoma, RCC) nakon prethodnog neuspješnog liječenja sunitinibom ili citokinom.
English: Your doctor should do blood tests to check your liver function before and during treatment with Inlyta.
Croatian: Liječnik Vam mora provoditi pretrage krvi kako bi provjerio rad jetre prije i za vrijeme liječenja lijekom Inlyta.
English: The most commonly reported liver-related adverse reactions included increases in alanine aminotransferase (ALT), aspartate aminotransferase (AST), and blood bilirubin (see section 4.8).
Croatian: Najčešće prijavljene nuspojave povezane s funkcijom jetre uključuju povišene razine alanin aminotransferaze (ALT), aspartat aminotransferaze (AST) i bilirubina u krvi (vidjeti dio 4.8).
English: If your thyroid gland is not producing enough thyroid hormone before, or while on treatment with this medicine, you should be treated with thyroid hormone replacement.
Croatian: Ako Vam štitna žlijezda prije ili tijekom liječenja ovim lijekom ne luči dovoljno hormona, morat ćete primati lijek koji će nadomjestiti hormone štitnjače.
English: Population pharmacokinetic analyses have shown that axitinib clearance was not altered in subjects with renal impairment and no dose adjustment of axitinib is required.
Croatian: Analize populacijske farmakokinetike pokazale su da se klirens aksitiniba nije promijenio u ispitanika s oštećenjem bubrega te nije potrebno prilagođavati dozu aksitiniba.
English: • Changes in the levels of different chemicals/enzymes in the blood (may show in your blood tests)
Croatian: • promjene vrijednosti različitih kemijskih tvari/enzima u krvi (mogu se vidjeti iz rezultata krvnih pretraga)
English: Inlyta is indicated for the treatment of advanced kidney cancer (advanced renal cell carcinoma) in adults, when another medicine (called sunitinib or a cytokine) is no longer stopping disease from progressing.
Croatian: Inlyta je namijenjena za liječenje uznapredovalog raka bubrega (uznapredovali karcinom bubrežnih stanica) u odraslih bolesnika kada drugi lijek (sunitinib ili citokin) više ne može zaustaviti napredovanje bolesti.
English: • If you suffer from bleeding problems.
Croatian: • ako imate tegoba s krvarenjem.
English: A high fat, high-calorie meal resulted in 19% higher exposure compared to overnight fasting.
Croatian: Visokokaloričan punomastan obrok doveo je do 19% veće izloženosti u odnosu na primjenu natašte.
English: • Shortness of breath, cough, hoarseness
Croatian: • nedostatak zraka, kašalj, promuklost
English: Virtually no data are available regarding axitinib treatment in patients with a creatinine clearance of < 15 mL/min.
Croatian: Nema nikakvih podataka o terapiji aksitinibom u bolesnika s klirensom kreatinina < 15 ml/min.
English: There was no effect on mating or fertility in male mice at exposure levels approximately 57-fold the expected human exposure.
Croatian: Nije bilo utjecaja na parenje ni plodnost kod mužjaka miševa pri razini izloženosti približno 57 puta većoj od očekivane izloženosti u ljudi.
English: • If you have had a recent problem with blood clots in your veins and arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis.
Croatian: • ako ste nedavno imali tegobe s krvnim ugrušcima u venama i arterijama (vrste krvnih žila), uključujući moždani udar, srčani udar, emboliju ili trombozu.
English: Some medicines may affect Inlyta, or be affected by it.
Croatian: Neki lijekovi mogu djelovati na lijek Inlyta ili Inlyta može djelovati na njih.
English: Patients (N = 723) with advanced RCC whose disease had progressed on or after treatment with one prior systemic therapy, including sunitinib-, bevacizumab-, temsirolimus-, or cytokinecontaining regimens were randomised (1:1) to receive axitinib (N = 361) or sorafenib (N = 362).
Croatian: Bolesnici (N = 723) s uznapredovalim RCC-om, u kojih je bolest napredovala tijekom ili nakon terapije jednom prethodnom sustavnom terapijom, uključujući protokole koji su sadržavali sunitinib, bevacizumab, temsirolimus ili citokin, nasumce su raspoređeni (1:1) da primaju aksitinib (N = 361) ili sorafenib (N = 362).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 3 September 2012
Croatian: DATUM PRVOG ODOBRENJA/DATUM OBNOVE ODOBRENJA
English: The primary endpoint, progression-free survival (PFS), was assessed using a blinded independent central review.
Croatian: Primarna mjera ishoda bilo je preživljenje bez progresije bolesti (engl. progression-free survival, PFS), koje se utvrđivalo maskiranom neovisnom centraliziranom procjenom.
English: Axitinib is for oral use.
Croatian: Aksitinib je namijenjen za peroralnu primjenu.
English: Blood pressure should be well-controlled prior to initiating axitinib.
Croatian: Krvni tlak treba biti dobro reguliran prije uvođenja terapije aksitinibom.
English: Of the patients enrolled in this study, 389 patients (53.8%) had received one prior sunitinib-based therapy, 251 patients (34.7%) had received one prior cytokine-based therapy (interleukin-2 or interferon-alpha), 59 patients (8.2%) had received one prior bevacizumab-based therapy, and 24 patients (3.3%) had received one prior temsirolimus-based therapy.
Croatian: Od bolesnika uključenih u ovo ispitivanje 389 (53,8%) ih je primilo jednu prethodnu terapiju utemeljenu na sunitinibu, 251 bolesnik (34,7%) primio je jednu prethodnu terapiju utemeljenu na citokinu (interleukin-2 ili interferon-alfa), 59 bolesnika (8,2%) je dobilo jednu prethodnu terapiju utemeljenu na bevacizumabu, a 24 su bolesnika (3,3%) dobila jednu prethodnu terapiju utemeljenu na temsirolimusu.
English: Wound healing complications No formal studies of the effect of axitinib on wound healing have been conducted.
Croatian: Otežano cijeljenje rana Nisu provedena formalna ispitivanja utjecaja aksitiniba na cijeljenje rana.
English: The effect of strong inhibitors of these isozymes on axitinib pharmacokinetics has not been studied.
Croatian: Nije ispitivan utjecaj snažnih inhibitora tih izoenzima na farmakokinetiku aksitiniba.
English: In a clinical dose finding study with axitinib, subjects who received starting doses of 10 mg twice daily or 20 mg twice daily experienced adverse reactions which included hypertension, seizures associated with hypertension, and fatal haemoptysis.
Croatian: U kliničkom ispitivanju za utvrđivanje doze aksitiniba ispitanici koji su primali početne doze od 10 mg dvaput na dan ili 20 mg dvaput na dan iskusili su nuspojave koje uključuju hipertenziju, konvulzije povezane s hipertenzijom i smrtonosnu hemoptizu.
English: Grapefruit may also increase axitinib plasma concentrations.
Croatian: I grejp može povećati koncentracije aksitiniba u plazmi.
English: Τηλ: +30 210 6785 800
Croatian: Τλ: +30 210 6785 800
English: Common: may affect up to 1 in 10 people
Croatian: Često: (mogu se javiti u do 1 na 10 osoba):
English: • Sore throat or nose and throat irritation
Croatian: • grlobolja ili nadraženost nosa i grla
English: • St. John's wort (Hypericum perforatum), a herbal product used to treat depression.
Croatian: • gospina trava (Hypericum perforatum), biljni lijek koji se koristi za liječenje depresije.
English: • ketoconazole or itraconazole, used to treat fungal infections;
Croatian: • ketokonazol ili itrakonazol, koji se koriste za liječenje gljivičnih infekcija,
English: Tell your doctor if you get tired more easily, generally feel colder than other people, or your voice deepens whilst taking this medicine.
Croatian: Obavijestite liječnika ako se tijekom liječenja ovim lijekom brže umarate, ako primjećujete da Vam je hladnije nego drugim ljudima ili Vam se produbi glas.
English: CYP1A2 and CYP2C19 inhibitors
Croatian: Inhibitori CYP1A2 i CYP2C19
English: 56 tablets
Croatian: 60 tableta
English: During routine laboratory assessments, in patients who had TSH < 5 μU/mL before treatment, elevations of TSH to ≥ 10 μU/mL occurred in 32.2% of patients receiving axitinib.
Croatian: Tijekom rutinskih laboratorijskih kontrola primijećeno je da je među bolesnicima koji su prije terapije imali TSH < 5 µU/ml došlo do povišenja razine TSH-a na ≥ 10 µU/ml u 32,2% bolesnika koji su primali aksitinib.
English: Inlyta may increase the risk of developing a 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: Inlyta može povećati rizik za nastanak pukotina u želucu ili crijevima ili stvaranje fistula (neuobičajenih spojeva u obliku cjevčice između dviju tjelesnih šupljina ili između neke tjelesne šupljine i kože).
English: Therefore, co-administration of axitinib is not expected to increase the plasma concentration of digoxin, or other P-glycoprotein substrates,
Croatian: Stoga se ne očekuje da će istodobna primjena aksitiniba povećati plazmatske koncentracije digoksina ili drugih supstrata P-glikoproteina in vivo.
English: • Weight loss
Croatian: • gubitak tjelesne težine
English: Therefore, coadministration of axitinib with CYP1A2 substrates may result in increased plasma concentrations of CYP1A2 substrates (e.g. theophylline).
Croatian: Stoga istodobna primjena aksitiniba sa supstratima CYP1A2 može rezultirati povećanjem plazmatskih koncentracija supstrata CYP1A2 (npr. teofilina).
English: Each pack contains 28 or 56 film-coated tablets.
Croatian: Jedno pakiranje sadrži 28 ili 56 filmom obloženih tableta.
English: The European Medicines Agency has waived the obligation to submit the results of studies with axitinib in all subsets of the paediatric population for treatment of kidney and renal pelvis carcinoma (excluding nephroblastoma, nephroblastomatosis, clear cell sarcoma, mesoblastic nephroma, renal medullary carcinoma and rhabdoid tumour of the kidney) (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja aksitiniba u svim podskupinama pedijatrijske populacije u terapiji karcinoma bubrega i bubrežnog pelvisa (osim nefroblastoma, nefroblastomatoze, sarkoma svijetlih stanica, mezoblastičnog nefroma, medularnog karcinoma bubrega i rabdoidnog tumora bubrega) (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Tell your doctor if you have severe abdominal pain.
Croatian: Recite liječniku ako imate jake bolove u trbuhu.
English: Table 1 presents adverse reactions reported in a pooled dataset of 672 patients who received axitinib in clinical studies for the treatment of patients with RCC (see section 5.1).
Croatian: Tablici 1 prikazane su nuspojave prijavljene u objedinjenom skupu podataka od 672 bolesnika koji su primali aksitinib u kliničkim ispitivanjima u terapiji bolesnika s RCC-om (vidjeti dio 5.1).