natgillin/translations-raw huggingface dataset:
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. 
Čeprav prilagajanja odmerkov aksitiniba pri bolnikih, ki prejemajo močne zaviralce CYP3A4/5, niso preučevali, pa je v primeru sočasne uporabe močnega zaviralca CYP3A4/5 odmerek aksitiniba priporočljivo zmanjšati na približno polovico odmerka (npr. začetni odmerek 5 mg dvakrat na dan je treba zmanjšati na 2 mg dvakrat na dan).
Taking into account the PRAC Assessment Report on the PSUR(s) for axitinib, the scientific conclusions of CHMP are as follows: 
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za aksitinib je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
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. 
In vitro študije zaviranja in induciranja CYP in UGT Študije in vitro so pokazale, da aksitinib v terapevtskih plazemskih koncentracijah ne zavira CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/5 ali UGT1A1.
However, axitinib is not expected to inhibit P-glycoprotein at therapeutic plasma concentrations. 
Vendar pa ni pričakovati, da bi aksitinib v terapevtskih plazemskih koncentracijah zaviral P-glikoprotein.
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. 
Pri zdravih prostovoljcih je rifampicin, močan induktor CYP3A4/5 (v odmerku 600 mg enkrat na dan v obdobju 9 dni), pri enkratnem 5 mg odmerku aksitiniba povprečno AUC zmanjšal za 79 %, Cmax pa za 71 %.
One-sided p-value from Cochran-Mantel-Haenszel test of treatment stratified by ECOG performance status. 
Enostranska vrednost p, dobljena iz Cochran-Mantel-Haenszel testa zdravljenja, stratificirana po stanju zmogljivosti po ECOG.
• Presence of red blood cells in the urine (may show in your urine tests) 
• prisotnost rdečih krvnih celic v urinu (to se lahko pokaže pri preiskavah urina)
Virtually no data are available regarding axitinib treatment in patients with a creatinine clearance of < 15 mL/min. 
O uporabi aksitiniba pri bolnikih z očistkom kreatinina < 15 ml/min praktično ni podatkov.
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. 
V kliničnem preskušanju za določitev odmerka aksitiniba je pri osebah, ki so prejemale začetne odmerke 10 mg dvakrat na dan oziroma 20 mg dvakrat na dan, prišlo do pojava neželenih učinkov, ki so vključevali hipertenzijo, epileptične napade, povezane s hipertenzijo, in hemoptizo s smrtnim izidom.
The following medicines may increase the risk of side effects with Inlyta: 
Naslednja zdravila lahko zvečajo tveganje za pojav neželenih učinkov zdravila Inlyta:
What you need to know before you take Inlyta Do not take Inlyta: 
Kaj morate vedeti, preden boste vzeli zdravilo Inlyta
In vitro studies indicated that axitinib inhibits P-glycoprotein. 
Študije in vitro so pokazale, da aksitinib zavira P-glikoprotein.
In cases of suspected overdose, axitinib should be withheld and supportive care instituted. 
Pri sumu na preveliko odmerjanje je treba zdravljenje z aksitinibom prekiniti in uvesti podporno zdravljenje.
Axitinib is metabolised primarily in the liver by CYP3A4/5 and to a lesser extent by CYP1A2, CYP2C19, and UGT1A1. 
Aksitinib se presnavlja predvsem v jetrih preko CYP3A4/5, v manjši meri pa preko CYP1A2, CYP2C19 in UGT1A1.
No dose adjustment is required when administering axitinib to patients with mild hepatic impairment (Child-Pugh class A). 
Prilagajanje odmerka ni potrebno, kadar se aksitinib daje bolnikom z blago okvaro jeter (razred A po Child-Pughu).
HDPE bottle with a silica gel desiccant and a polypropylene closure containing 180 film-coated tablets. 
Plastenka iz polietilena visoke gostote (HDPE), s silikagelom kot sušilnim sredstvom in zamaškom iz polipropilena, ki vsebuje 180 filmsko obloženih tablet.
• Blood clots in your veins and arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis. 
• Krvni strdki v venah ali arterijah (vrsti krvnih žil), vključno z možgansko kapjo, srčnim infarktom, embolijo ali trombozo.
• Diarrhoea, feeling or being sick (nausea or vomiting), stomach ache, indigestion, soreness of the mouth, tongue or throat, constipation 
• driska, občutek slabosti (slabost s siljenjem na bruhanje ali bruhanje), bolečine v želodcu, slaba prebava, bolečine v ustih, jeziku ali grlu, zaprtje
Overall ITT 
Celokupna ITT
If you are taking any of them, tell your doctor, pharmacist or nurse. 
Če jemljete katerokoli izmed njih, to povejte zdravniku, farmacevtu ali medicinski sestri.
Unchanged axitinib is not detected in the urine. 
Okvara ledvic Nespremenjenega aksitiniba v urinu ni mogoče zaznati.
Tell your doctor if you experience excessive tiredness, swelling of the abdomen, legs, or ankles, shortness of breath, or protruding neck veins. 
Obvestite zdravnika, če se pojavijo čezmerna utrujenost, otekanje trebuha, nog ali gležnjev, kratka sapa ali izstopajoče žile na vratu.
Administration of axitinib with a moderate fat meal resulted in 10% lower exposure compared to overnight fasting. 
Jemanje aksitiniba skupaj z obrokom zmerno mastne hrane je povzročilo 10 % manjšo izpostavljenost v primerjavi z jemanjem zdravila zjutraj, na tešče.
Some medicines may affect Inlyta, or be affected by it. 
Nekatera zdravila lahko vplivajo na delovanje zdravila Inlyta ali pa zdravilo Inlyta vpliva na njihovo delovanje.
• Changes in the levels of different chemicals/enzymes in the blood (may show in your blood tests) 
• spremembe vrednosti različnih snovi/encimov v krvi (to se lahko pokaže pri preiskavah krvi)
If you forget to take Inlyta 
Če ste pozabili vzeti zdravilo Inlyta
Management of cardiac failure events may require temporary interruption or permanent discontinuation and/or dose reduction of axitinib therapy. 
Obravnava dogodkov srčnega popuščanja lahko zahteva začasno ali stalno prekinitev zdravljenja z aksitinibom in/ali zmanjšanje odmerka.
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. 
V kliničnih preskušanjih z aksitinibom je bila sistemska izpostavljenost aksitinibu pri osebah z zmerno okvaro jeter (razred B po Child-Pughu) približno dvakrat večja kot pri osebah z normalnim delovanjem jeter.
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%). 
Hemoragični neželeni učinki pri bolnikih, ki so se zdravili z aksitinibom, so bili epistaksa (7,8 %), hematurija (3,6 %), hemoptiza (2,5 %), rektalna krvavitev (2,2 %), krvavitev iz dlesni (1,1 %), želodčna krvavitev (0,6 %), možganska krvavitev (0,3 %) in krvavitev v spodnjem delu prebavil (0,3 %).
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. 
Pri brejih miših, izpostavljenih aksitinibu, so ugotavljali zvečano pogostnost pojavljanja razcepljenega neba in sprememb na skeletu, vključno z zapoznelo zakostenitvijo, pri stopnjah izpostavljenosti, ki so bile manjše od pričakovane izpostavljenosti pri ljudeh.
Grade 4b 
4. stopnja
Therefore co-administration of axitinib is not expected to reduce the plasma concentration of co-administered CYP1A1, CYP1A2, or CYP3A4/5 substrates in vivo. 
Zato ni pričakovati, da bi sočasna uporaba aksitiniba zmanjšala plazemske koncentracije sočasno uporabljenih substratov CYP1A1, CYP1A2 ali CYP3A4/5 in vivo.
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. 
V nadzorovanem kliničnem preskušanju z aksitinibom pri zdravljenju bolnikov z RCC so o hipotiroidizmu poročali pri 20,9 % bolnikov, o hipertiroidizmu pa pri 1,1 % bolnikov.
• 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). 
• Predrtje želodca ali črevesa ali nastanek fistule (nenormalen, cevi podoben prehod iz ene normalne telesne votline do druge telesne votline ali kože).
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. 
Pomembno zvečanje poliploidnosti so opažali in vitro pri koncentracijah > 0,22 µg/ml, opazili pa so tudi zvečanje števila mikrojedrnih polikromatskih eritrocitov in vivo, pri čemer je bila raven NOAEL
Posterior reversible encephalopathy syndrome (PRES) In clinical studies with axitinib, events of PRES were reported (see section 4.8). 
Sindrom posteriorne reverzibilne encefalopatije (PRES) V kliničnih preskušanjih z aksitinibom so poročali o primerih PRES (glejte poglavje 4.8).
If you stop taking Inlyta 
Če ste prenehali jemati zdravilo Inlyta
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. 
V klinična preskušanja z aksitinibom pri zdravljenju bolnikov z RCC niso bili vključeni bolniki, pri katerih je raven serumskega kreatinina presegala 1,5-kratnik ZMN oziroma je izračunani očistek kreatinina znašal < 60 ml/min.
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). 
Uporabe aksitiniba pri bolnikih s hudo okvaro jeter (razred C po ChildPughu) niso preučevali, zato se ga pri tej populaciji ne sme uporabljati (glejte poglavji 4.4 in 5.2).
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. 
V nadzorovanem kliničnem preskušanju z aksitinibom pri zdravljenju bolnikov z RCC, iz katerega so bili izključeni bolniki z nezdravljenimi metastazami v možganih, so o hemoragičnih neželenih učinkih poročali pri 21,4 % bolnikov, ki so prejemali aksitinib.
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. 
Opažanja pri samicah so vključevala znake zapoznele spolne zrelosti, zmanjšanje števila ali odsotnost rumenih telesc, zmanjšanje mase maternice in atrofijo maternice pri izpostavljenosti, ki je bila približno enaka pričakovani izpostavljenosti pri ljudeh.
In vitro studies also indicated that axitinib has the potential to inhibit CYP2C8. 
Študije in vitro so pokazale tudi, da aksitinib lahko zavira CYP2C8.
HDPE bottle with a silica gel desiccant and a polypropylene closure containing 60 film-coated tablets. 
Plastenka iz polietilena visoke gostote (HDPE), s silikagelom kot sušilnim sredstvom in zamaškom iz polipropilena, ki vsebuje 60 filmsko obloženih tablet.
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). 
V kliničnih preskušanjih z aksitinibom pri zdravljenju bolnikov z RCC so poročali o primerih hipotiroidizma in, v manjšem obsegu, hipertiroidizma (glejte poglavje 4.8).
How to take Inlyta 
Kako jemati zdravilo Inlyta
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). 
V primerjavi z osebami z normalnim delovanjem jeter je bila sistemska izpostavljenost po enkratnem odmerku aksitiniba pri osebah z blago okvaro jeter (razred A po Child-Pughu) podobna, pri osebah z zmerno okvaro jeter (razred B po Child-Pughu) pa večja (za približno dvakrat).
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. 
V nadzorovanem kliničnem preskušanju z aksitinibom pri zdravljenju bolnikov z RCC je bilo 34 % bolnikov, ki so prejemali aksitinib, starih 65 let ali več.
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). 
Uporabe aksitiniba pri osebah s hudo okvaro jeter (razred C po Child-Pughu) niso preučevali, zato se ga pri tej populaciji ne sme uporabljati (za priporočila glede prilagajanja odmerka glejte poglavje 4.2).
Kaplan-Meier curve of progression-free survival by independent assessment for the prior sunitinib subgroup 
Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni (neodvisna ocena) za podskupino, ki je predhodno prejemala sunitinib
Increases in haemoglobin or haematocrit, reflective of increases in red blood cell mass, may occur during treatment with axitinib (see section 4.8, polycythaemia). 
Med zdravljenjem z aksitinibom lahko pride do zvišanj ravni hemoglobina ali hematokrita, kar je posledica zvečanja mase rdečih krvničk (glejte poglavje 4.8, policitemija).
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. 
Podatki in vitro kažejo, da se aksitinib presnavlja predvsem preko CYP3A4/5, v manjšem obsegu pa preko CYP1A2, CYP2C19 in uridin difosfat-glukuronoziltransferaze (UGT) 1A1.
In a controlled clinical study with axitinib for the treatment of patients with RCC, liver-related adverse reactions were reported. 
V nadzorovanem kliničnem preskušanju z aksitinibom pri zdravljenju bolnikov z RCC so poročali o neželenih učinkih na jetra.
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. 
Med rutinskimi laboratorijskimi preiskavami je pri 32,2 % bolnikov, ki so prejemali aksitinib in imeli pred zdravljenjem koncentracijo TSH < 5 μU/ml, prišlo do zvečanj koncentracij TSH na ≥ 10 μU/ml.
h One-sided p-value from a log-rank test of treatment stratified by ECOG performance status. 
Enostranska vrednost p, dobljena iz log-rank testa zdravljenja, stratificirana po stanju zmogljivosti po ECOG.
Each blister pack contains 28 tablets or 56 tablets. 
Pakiranje v pretisnih omotih vsebuje 28 ali 56 tablet.
Grade 3 haemorrhagic adverse reactions were reported in 3% of patients. 
O hemoragičnih neželenih učinkih 3. stopnje so poročali pri 3 % bolnikov.
Inlyta 1 mg film-coated tablets Inlyta 3 mg film-coated tablets Inlyta 5 mg film-coated tablets Inlyta 7 mg film-coated tablets 
Inlyta 1 mg filmsko obložene tablete Inlyta 3 mg filmsko obložene tablete Inlyta 5 mg filmsko obložene tablete Inlyta 7 mg filmsko obložene tablete
Axitinib has not been studied in patients with severe hepatic impairment (Child-Pugh class C) and should not be used in this population. 
Uporabe aksitiniba pri bolnikih s hudo okvaro jeter (razred C po Child-Pughu) niso preučevali, zato se ga pri tej populaciji ne sme uporabljati.
Dose increase or reduction is recommended based on individual safety and tolerability. 
Odmerek je priporočljivo zvečati ali zmanjšati, odvisno od tega, kako varna je uporaba zdravila pri posameznem bolniku in kako bolnik zdravljenje prenaša.
What Inlyta contains 
Kaj vsebuje zdravilo Inlyta
Fatal pulmonary embolism was reported in one patient (0.3%) receiving axitinib. 
O pljučni emboliji s smrtnim izidom so poročali pri enem bolniku (0,3 %), ki je prejemal aksitinib.
If co-administration of the strong inhibitor is discontinued, a return to the axitinib dose used prior to initiation of the strong CYP3A4/5 inhibitor should be considered (see section 4.5). 
Če prekinemo sočasno uporabo močnega zaviralca, je treba razmisliti o vrnitvi na odmerek aksitiniba, ki je bil uporabljen pred uvedbo močnega zaviralca CYP3A4/5 (glejte poglavje 4.5).
Your doctor should make sure that your blood pressure is under control before starting Inlyta treatment, and while on treatment with this medicine. 
Zdravnik se mora pred začetkom zdravljenja z zdravilom Inlyta in med zdravljenjem prepričati, da je vaš krvni tlak pod nadzorom.
c One-sided p-value from a log-rank test of treatment stratified by ECOG performance status and prior therapy. 
Enostranska vrednost p, dobljena iz log-rank testa zdravljenja, stratificirana po stanju zmogljivosti po ECOG in predhodnem zdravljenju.
Axitinib was not mutagenic or clastogenic in conventional genotoxicity assays in vitro. 
V običajnih preskušanjih genotoksičnosti in vitro aksitinib ni deloval mutageno ali klastogeno.
In clinical studies with axitinib, proteinuria, including that of Grade 3 and 4 severity, was reported (see section 4.8). 
V kliničnih preskušanjih z aksitinibom so poročali o proteinuriji, vključno s proteinurijo 3. in 4. stopnje izraženosti (glejte poglavje 4.8).
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. 
Pri zdravih prostovoljcih je ketokonazol, močan zaviralec CYP3A4/5 (v odmerku 400 mg enkrat na dan v obdobju 7 dni) pri enkratnem 5 mg peroralnem odmerku aksitiniba povprečno vrednost površine pod krivuljo (AUC) zvečal za 2-krat, Cmax pa za 1,5-krat.
Co-administration of axitinib with strong CYP3A4/5 inducers (e.g. rifampicin, dexamethasone, phenytoin, carbamazepine, rifabutin, rifapentin, phenobarbital, and Hypericum perforatum [St. 
Sočasna uporaba aksitiniba z močnimi induktorji CYP3A4/5 (npr. rifampicin, deksametazon, fenitoin, karbamazepin, rifabutin, rifapentin, fenobarbital in Hypericum perforatum [šentjanževka]) lahko zmanjša plazemske koncentracije aksitiniba.
Specific safety events should be monitored before initiation of, and periodically throughout, treatment with axitinib as described below. 
Pred začetkom zdravljenja z aksitinibom in v rednih časovnih presledkih med zdravljenjem je treba spremljati posebne, z varnostjo povezane dogodke, kot je opisano v nadaljevanju.
In vitro studies indicated that axitinib has a potential to inhibit CYP1A2. 
Študije in vitro so pokazale, da aksitinib lahko zavira CYP1A2.
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. 
V preskušanjih, v katerih so aksitinib uporabljali kot samostojno zdravilo (n = 850), so o arterijskih emboličnih in trombotičnih neželenih učinkih (vključno s prehodno možgansko ishemijo, miokardnim infarktom in cerebrovaskularnim insultom) poročali pri 5,3 % bolnikov, ki so prejemali aksitinib.
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. 
V preskušanjih, v katerih so aksitinib uporabljali kot samostojno zdravilo (n = 672) pri zdravljenju bolnikov z RCC, so o dogodkih srčnega popuščanja (vključno s srčnim popuščanjem, kongestivnim srčnim popuščanjem, kardiopulmonalno odpovedjo, disfunkcijo levega prekata, zmanjšanim iztisnim deležem in popuščanjem desnega prekata) poročali pri 1,8 % bolnikov, ki so prejemali aksitinib.
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 
Inlyta 1 mg filmsko obložene tablete Inlyta 3 mg filmsko obložene tablete Inlyta 5 mg filmsko obložene tablete Inlyta 7 mg filmsko obložene tablete aksitinib
Very common Palmar-plantar erythrodysaesthesia (hand-foot syndrome) Rash 
Bolezni kože in podkožja zelo pogosti palmarno-plantarna eritrodisestezíja (sindrom dlani-podplatov) izpuščaj suha koža pogosti srbenje
• Swelling of the abdomen, legs, or ankles, protruding neck veins, excessive tiredness, 
• otekanje trebuha, nog ali gležnjev, izstopajoče žile na vratu, čezmerna utrujenost, kratka sapa
• Reduction in the number of blood platelets (cells that help blood to clot) (may show in your blood tests) 
• zmanjšanje števila krvnih ploščic (celice, ki sodelujejo pri strjevanju krvi) (to se lahko pokaže pri preiskavah krvi)
In clinical studies with axitinib for the treatment of patients with RCC, hypertension was very commonly reported (see section 4.8). 
V kliničnih preskušanjih z aksitinibom pri zdravljenju bolnikov z RCC so o hipertenziji poročali zelo pogosto (glejte poglavje 4.8).
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). 
V kliničnih preskušanjih z aksitinibom so poročali o venskih emboličnih in trombotičnih dogodkih (vključno s pljučno embolijo, globoko vensko trombozo in zaporo/trombozo mrežnične vene) (glejte poglavje 4.8).
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. 
Razmerje tveganja > 1 je nakazovalo večjo verjetnost odzivanja v skupini, ki je prejemala aksitinib; razmerje tveganja < 1 je nakazovalo večjo verjetnost odzivanja v skupini, ki je prejemala sorafenib.
Management of some adverse reactions may require temporary or permanent discontinuation of axitinib therapy (see section 4.4). 
Za obvladovanje nekaterih neželenih učinkov bo morda treba začasno ali trajno prekiniti zdravljenje z aksitinibom (glejte poglavje 4.4).
Based on the pharmacological properties of axitinib, it may cause foetal harm when administered to a pregnant woman. 
Podatkov o uporabi aksitiniba pri nosečnicah ni. Glede na njegove farmakološke lastnosti bi aksitinib lahko škodoval plodu, če bi ga jemala nosečnica.
Co-administration of axitinib with strong CYP3A4/5 inducers may decrease axitinib plasma concentrations (see section 4.5). 
Sočasna uporaba aksitiniba z močnimi induktorji CYP3A4/5 lahko zmanjša plazemske koncentracije aksitiniba (glejte poglavje 4.5).
In four clinical studies with axitinib for the treatment of patients with RCC (N = 537), elevated haemoglobin above ULN was observed in 13.6% receiving axitinib. 
V štirih kliničnih preskušanjih z aksitinibom pri zdravljenju bolnikov z RCC (n = 537) so zvišane ravni hemoglobina nad ZMN ugotovili pri 13,6 % bolnikov, ki so prejemali aksitinib.