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.
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).
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 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.
• 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.
• ako tijekom liječenja ovim lijekom dobijete simptome poput glavobolje, smetenosti, napadaja ili promjena vida, uz povišenje krvnog tlaka ili bez njega.
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).
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).
• Reduction in the number of blood platelets (cells that help blood to clot) (may show in your blood tests)
• smanjen broj krvnih pločica (stanica koje pomažu u zgrušavanju krvi) (može se vidjeti iz rezultata krvnih pretraga)
The recommended dose of axitinib is 5 mg twice daily.
Doziranje Preporučena doza aksitiniba je 5 mg dvaput na dan.
If you stop taking Inlyta
Ako prestanete uzimati lijek Inlyta
The geometric mean oral clearance and apparent volume of distribution were 38 L/h and 160 L, respectively.
Geometrijska sredina klirensa nakon peroralne primjene bila je 38 l/h, a prividnog volumena raspodjele 160 l.
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).
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).
HDPE bottle with a silica gel desiccant and a polypropylene closure containing 180 film-coated tablets.
HDPE bočica sa sredstvom za sušenje (silika gel) i polipropilenskim čepom, koja sadrži 180 filmom obloženih tableta.
In vitro studies in human hepatocytes also indicated that axitinib does not induce CYP1A1, CYP1A2, or CYP3A4/5.
Ispitivanja in vitro na ljudskim hepatocitima također su pokazala da aksitinib ne inducira CYP1A1, CYP1A2 i CYP3A4/5.
In clinical studies with axitinib, proteinuria, including that of Grade 3 and 4 severity, was reported (see section 4.8).
U kliničkim ispitivanjima aksitiniba prijavljena je proteinurija, uključujući i onu stupnja 3 i 4 (vidjeti dio 4.8).
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.
U ispitivanjima aksitiniba u monoterapiji (N = 850) hemoptiza je prijavljena u 3,9% bolesnika; hemoptiza stupnja > 3 prijavljena je u 0,5% bolesnika.
A dose decrease is recommended when administering axitinib to patients with moderate hepatic impairment (Child-Pugh class B) (see section 4.2).
Preporučuje se smanjiti dozu kad se aksitinib primjenjuje u bolesnika s umjerenim oštećenjem jetre (Child-Pugh stadij B) (vidjeti dio 4.2).
If you forget to take Inlyta
Ako ste zaboravili uzeti lijek Inlyta
Cardiac failure events (see section 4.4)
Događaji zatajenja srca (vidjeti dio 4.4)
Uncommon Posterior reversible encephalopathy syndromee
Sindrom posteriorne reverzibilne encefalopatije (PRES)
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.
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.
The sulfoxide and N-glucuronide metabolites show approximately 400-fold and 8000-fold less in vitro potency, respectively, against VEGFR-2 compared to axitinib.
Sulfoksidni metabolit ima približno 400 puta, a N-glukuronid metabolit približno 8.000 puta slabije djelovanje od aksitiniba na VEGFR-2 in vitro.
Routine laboratory assessments detected elevated haemoglobin above ULN in 9.7% of patients receiving axitinib.
Rutinskim laboratorijskim pretragama povišenje razine hemoglobina iznad GGN otkriveno je u 9,7% bolesnika liječenih aksitinibom.
Therefore co-administration of axitinib is not expected to reduce the plasma concentration of co-administered CYP1A1, CYP1A2, or CYP3A4/5 substrates in vivo.
Stoga se ne očekuje da će istodobna primjena aksitiniba smanjiti plazmatske koncentracije supstrata CYP1A1, CYP1A2 i CYP3A4/5 in vivo.
Axitinib is metabolised primarily in the liver by CYP3A4/5 and to a lesser extent by CYP1A2, CYP2C19, and UGT1A1.
Aksitinib se primarno metabolizira u jetri pomoću CYP3A4/5 te u manjoj mjeri pomoću CYP1A2, CYP2C19 i UGT1A1.
In vitro studies indicated that axitinib inhibits P-glycoprotein.
Ispitivanja in vitro ukazala su na to da aksitinib inhibira P-glikoprotein.
In cases of suspected overdose, axitinib should be withheld and supportive care instituted.
U slučaju sumnje na predoziranje treba prekinuti uzimanje aksitiniba i uvesti suportivne mjere terapije.
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.
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.
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%).
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%).
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).
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).
d Cutoff date: 01 November 2011.
Podaci prikupljeni do: 1. studenog 2011.
Tell your doctor if you experience excessive tiredness, swelling of the abdomen, legs, or ankles, shortness of breath, or protruding neck veins.
Obavijestite liječnika ako primijetite prekomjerni umor, oticanje trbuha, nogu ili gležnjeva, kratkoću daha ili izbočene vratne žile.
What you need to know before you take Inlyta Do not take Inlyta:
"Što trebate znati prije nego počnete uzimati lijek Inlyta"):
If axitinib is interrupted, patients receiving antihypertensive medicinal products should be monitored for hypotension (see section 4.2).
Kod privremenog prekida terapije aksitinibom bolesnike koji uzimaju antihipertenzive treba nadzirati zbog moguće hipotenzije (vidjeti dio 4.2).
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.
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.
Post-marketing adverse reactions identified in clinical studies are also included.
Nuspojave zabilježene u kliničkim ispitivanjima nakon stavljanja lijeka u promet također su uključene u Tablicu 1.
HDPE bottle with a silica gel desiccant and a polypropylene closure containing 60 film-coated tablets.
HDPE bočica sa sredstvom za sušenje (silika gel) i polipropilenskim čepom, koja sadrži 60 filmom obloženih tableta.
• If you have liver problems.
• ako imate tegoba s jetrom.
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.
U kontroliranim kliničkim ispitivanjima aksitiniba u terapiji bolesnika s RCC-om, 34% bolesnika liječenih aksitinibom bilo je u dobi od ≥ 65 godina.
Partially reversible dental caries were observed in mice treated for more than 1 month at exposure levels similar to the expected human exposure.
Djelomično reverzibilan zubni karijes opažen je u miševa koji su primali aksitinib više od mjesec dana, pri razinama izloženosti sličnima očekivanoj izloženosti ljudi.
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.
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.
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.
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.
Your doctor should monitor for signs or symptoms of heart failure events periodically throughout treatment with axitinib.
Liječnik mora pratiti znakove ili simptome događaja zatajenja srca povremeno tijekom terapije aksitinibom.
Axitinib has not been studied in patients with severe hepatic impairment (Child-Pugh class C) and should not be used in this population.
Aksitinib nije ispitivan u bolesnika s teškim oštećenjem jetre (Child-Pugh stadij C) i ne smije se primjenjivati u toj populaciji.
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.
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.
In vitro studies also indicated that axitinib has the potential to inhibit CYP2C8.
Ispitivanja in vitro pokazala su i da aksitinib može inhibirati CYP2C8.
Hyperthyroidism was reported in 1.6% of patients receiving axitinib.
Hipertireoza je prijavljena u 1,6% bolesnika koji su primali aksitinib.
Management of some adverse reactions may require temporary or permanent discontinuation of axitinib therapy (see section 4.4).
Zbrinjavanje nekih nuspojava može zahtijevati privremen ili trajan prekid primjene aksitiniba (vidjeti dio 4.4).
f Including cardiac failure, cardiac failure congestive, cardiopulmonary failure, ejection fraction decreased, left ventricular dysfunction and right ventricular failure.
e uključujući leukoencefalopatiju uključujući zatajenje srca, kongestivno zatajenje srca, kardiopulmonalno zatajenje, smanjenje ejekcijske frakcije, poremećaj funkcije lijeve klijetke i zatajenje desne klijetke.
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.
Opažen je značajan porast poliploidije in vitro, pri koncentracijama od > 0,22 µg/ml, dok je in vivo opažen porast broja mikronukleusnih polikromatskih eritrocita.
Elevation of haemoglobin or haematocrit
Povišene razine hemoglobina i hematokrita
• The active substance is axitinib.
Djelatna tvar je aksitinib.
Kaplan-Meier curve of progression-free survival by independent assessment for the overall population
Slika 1: Kaplan-Meierova krivulja preživljenja bez progresije bolesti prema neovisnoj procjeni za ukupnu populaciju
How to take Inlyta
Kako uzimati lijek Inlyta
In a controlled clinical study with axitinib for the treatment of patients with RCC, liver-related adverse reactions were reported.
U kontroliranom kliničkom ispitivanju aksitiniba u terapiji bolesnika s RCC-om prijavljene su jetrene nuspojave.
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.
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.
Thyroid stimulating hormone (TSH) increased was reported as an adverse reaction in 5.3% of patients receiving axitinib.
Povišene razine hormona koji stimulira štitnjaču (TSH) prijavljene su kao nuspojava u 5,3% bolesnika koji su primali aksitinib.
Management of some adverse reactions may require temporary or permanent discontinuation and/or dose reduction of axitinib therapy (see section 4.4).
Zbrinjavanje nekih nuspojava može zahtijevati privremen ili trajan prekid primjene i/ili smanjenje doze aksitiniba (vidjeti dio 4.4).
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.
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.
See section 4.
PRILOG IV.
• Fistula (abnormal tube like passage from one normal body cavity to another body cavity or the skin)
• fistula (neuobičajen spoj u obliku cjevčice između dviju tjelesnih šupljina ili između neke tjelesne šupljine i kože)
c One-sided p-value from a log-rank test of treatment stratified by ECOG performance status and prior therapy.
Jednostrana p-vrijednost iz log-rang testa terapije stratificiranog prema ECOG statusu i prethodnoj terapiji.
Kaplan-Meier curve of progression-free survival by independent assessment for the prior sunitinib subgroup
Slika 2: Kaplan-Meierova krivulja preživljenja bez progresije bolesti prema neovisnoj procjeni za podskupinu prethodno liječenu sunitinibom
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.
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.
Fatal pulmonary embolism was reported in one patient (0.3%) receiving axitinib.
Smrtonosna plućna embolija prijavljena je u jednog bolesnika (0,3%) liječenog aksitinibom.
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.
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.
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.
Omjer rizika > 1 ukazuje na veću vjerojatnost odgovora u skupini liječenoj aksitinibom; omjer rizika < 1 ukazuje na veću vjerojatnost odgovora u skupini liječenoj sorafenibom.
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.
U kontroliranom kliničkom ispitivanju aksitiniba u terapiji bolesnika s RCC-om hipotireoza je prijavljena u 20,9%, a hipertireoza u 1,1% bolesnika.
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.
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.
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).
U kliničkim ispitivanjima aksitiniba u terapiji bolesnika s RCC-om prijavljeni su hipotireoza i, u manjoj mjeri, hipertireoza (vidjeti dio 4.8).
• Swelling of the abdomen, legs, or ankles, protruding neck veins, excessive tiredness,
• oticanje trbuha, nogu ili gležnjeva, izbočene vratne žile, prekomjerni umor, kratkoća daha
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.
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.
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.
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.
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.
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.
In vitro studies indicated that axitinib has a potential to inhibit CYP1A2.
Ispitivanja in vitro pokazala su da aksitinib može inhibirati CYP1A2.
Increases in haemoglobin or haematocrit, reflective of increases in red blood cell mass, may occur during treatment with axitinib (see section 4.8, polycythaemia).
Tijekom terapije aksitinibom može doći do povišenja razine hemoglobina ili hematokrita, što upućuje na povećanu masu crvenih krvnih stanica (vidjeti dio 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.
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.
Co-administration of axitinib with strong CYP3A4/5 inhibitors may increase axitinib plasma concentrations (see section 4.5).
Istodobna primjena aksitiniba sa snažnim inhibitorima CYP3A4/5 može povećati koncentracije aksitiniba u plazmi (vidjeti dio 4.5).
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.
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.
h One-sided p-value from a log-rank test of treatment stratified by ECOG performance status.
Jednostrana p-vrijednost iz log-rang testa terapije stratificiranog prema ECOG statusu.
Co-administration of axitinib with strong CYP3A4/5 inducers may decrease axitinib plasma concentrations (see section 4.5).
Istodobna primjena aksitiniba sa snažnim induktorima CYP3A4/5 može smanjiti koncentracije aksitiniba u plazmi (vidjeti dio 4.5).
• Diarrhoea, feeling or being sick (nausea or vomiting), stomach ache, indigestion, soreness of the mouth, tongue or throat, constipation
• proljev, mučnina ili povraćanje, bol u trbuhu, probavne tegobe, bol u ustima, jeziku ili grlu,
Axitinib has not been studied in patients < 18 years of age.
Pedijatrijska populacija Aksitinib nije ispitivan u bolesnika mlađih od 18 godina.
Tell your doctor if you have severe abdominal pain while on treatment with this medicine.
Obavijestite svog liječnika ako tijekom liječenja ovim lijekom imate jake bolove u trbuhu.
Overall ITT
Ukupna ITT populacija
Co-administration of axitinib with strong CYP3A4/5 inducers (e.g. rifampicin, dexamethasone, phenytoin, carbamazepine, rifabutin, rifapentin, phenobarbital, and Hypericum perforatum [St.
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.
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 filmom obložene tablete Inlyta 3 mg filmom obložene tablete Inlyta 5 mg filmom obložene tablete Inlyta 7 mg filmom obložene tablete
Median OS d in months (95% CI)
(95% CI) Medijan OS-a d u mjesecima
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.
Odmah potražite hitnu medicinsku pomoć ako dobijete simptome poput glavobolje, smetenosti, napadaja ili promjena vida, uz povišenje krvnog tlaka ili bez njega.
• 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).
• Puknuće stijenke želuca ili crijeva ili stvaranje fistula (neuobičajenih spojeva u obliku cjevčice između dviju tjelesnih šupljina ili između neke tjelesne šupljine i kože).
shortness of breath (signs of heart failure events)
(znakovi događaja zatajenja srca