natgillin/translations-raw huggingface dataset:
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).
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).
Patients should be advised that they may experience events such as dizziness and/or fatigue during treatment with axitinib.
Bolesnike treba upozoriti da tijekom terapije aksitinibom mogu osjetiti omaglicu i/ili umor.
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 filmom obložene tablete Inlyta 3 mg filmom obložene tablete Inlyta 5 mg filmom obložene tablete Inlyta 7 mg filmom obložene tablete aksitinib
Unchanged axitinib is not detected in the urine.
U mokraći nije detektiran nepromijenjen aksitinib.
Fatal haemorrhage was reported in one patient (0.3%) receiving axitinib (gastric haemorrhage).
Smrtonosno krvarenje prijavljeno je u jednog bolesnika (0,3%) liječenog aksitinibom (radilo se o želučanom krvarenju).
In clinical studies with axitinib for the treatment of patients with RCC, hypertension was very commonly reported (see section 4.8).
U kliničkim ispitivanjima aksitiniba u terapiji bolesnika s RCC-om hipertenzija je prijavljena vrlo često (vidjeti dio 4.8).
Haemorrhage (see section 4.4)
Krvarenje (vidjeti dio 4.4)
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
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
Oropharyngeal pain
• upala žučnog mjehura
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).
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).
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.
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.
Cardiac failure events
Događaji zatajenja srca
Grade > 3 haemorrhagic adverse reactions were reported in 3.1% of patients receiving axitinib (including cerebral haemorrhage, gastric haemorrhage, lower gastrointestinal haemorrhage and haemoptysis).
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).
How to store Inlyta
Kako čuvati lijek Inlyta
Signs or symptoms of cardiac failure should periodically be monitored throughout treatment with axitinib.
Znakove ili simptome zatajenja srca mora se povremeno pratiti tijekom terapije aksitinibom.
If a strong CYP3A4/5 inducer must be co-administered, a dose adjustment of axitinib is recommended (see section 4.2).
Mora li se istodobno primijeniti snažan induktor CYP3A4/5, preporučuje se prilagoditi dozu aksitiniba (vidjeti dio 4.2).
Caution should be exercised due to the risk of increased axitinib plasma concentrations in patients taking strong inhibitors of these isozymes.
U bolesnika koji uzimaju snažne inhibitore tih izoenzima potreban je oprez zbog opasnosti od povećanja koncentracija aksitiniba u plazmi.
Grade 3 venous embolic and thrombotic events were reported in 0.9% of patients.
Venski embolijski i trombotski događaji stupnja 3 prijavljeni su u 0,9% bolesnika.
If a strong CYP3A4/5 inhibitor must be co-administered, a dose adjustment of axitinib is recommended (see section 4.2).
Mora li se istodobno primijeniti snažan inhibitor CYP3A4/5, preporučuje se prilagoditi dozu aksitiniba (vidjeti dio 4.2).
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.
U četiri klinička ispitivanja aksitiniba u terapiji bolesnika s RCC-om (N = 537) povišenje razine hemoglobina iznad GGN opaženo je u 13,6% bolesnika koji su primali aksitinib.
• Increase in the number of red blood cells (may show in your blood tests)
• povećan broj crvenih krvnih stanica (može se vidjeti iz rezultata krvnih pretraga)
Liver function tests should be monitored before initiation of, and periodically throughout, treatment with axitinib.
Treba kontrolirati rezultate testova funkcije jetre prije početka i povremeno tijekom terapije aksitinibom.
• Protein in the urine (may show in your urine tests)
• proteini u mokraći (mogu se vidjeti iz rezultata krvnih pretraga)
Cardiac failure eventsc,d,f
Srčani poremećaji često događaji zatajenja srca c,d,f
• Reduction in the number of red blood cells (may show in your blood tests)
• smanjen broj crvenih krvnih stanica (može se vidjeti iz rezultata krvnih pretraga)
If co-administration of the strong inducer is discontinued, the axitinib dose should be immediately returned to the dose used prior to initiation of the strong CYP3A4/5 inducer (see section 4.5).
Prekine li se istodobna primjena snažnog induktora CYP3A4/5, dozu aksitiniba treba odmah vratiti na onu koja se primjenjivala prije uvođenja tog snažnog induktora (vidjeti dio 4.5).
Kaplan-Meier curve of progression-free survival by independent assessment for the prior cytokine subgroup
Slika 3: Kaplan-Meierova krivulja preživljenja bez progresije bolesti prema neovisnoj procjeni za podskupinu prethodno liječenu citokinom
Maximal induction with high-dose strong CYP3A4/5 inducers has been reported to occur within one week of treatment with the inducer.
Zabilježeno je da maksimalna indukcija nastupa u roku od tjedan dana terapije visokom dozom jakih induktora CYP3A4/5.
Very common Arthralgia Pain in extremity
Poremećaji mišićno-koštanog sustava i vezivnog tkiva vrlo često artralgija bol u ekstremitetima često mialgija
Fatal cardiac failure was reported in 0.6 % of patients receiving axitinib.
Smrtonosno zatajenje srca prijavljeno je u 0,6% bolesnika koji su primali aksitinib.
In a controlled clinical study with axitinib for the treatment of patients with RCC, arterial embolic and thrombotic adverse reactions were reported in 4.7% of patients receiving axitinib, including myocardial infarction (1.4%), transient ischemic attack (0.8%) and cerebrovascular accident (0.6%).
Arterijski embolijski i trombotski događaji (vidjeti dio 4.4) U kontroliranom kliničkom ispitivanju aksitiniba u terapiji bolesnika s RCC-om, arterijske embolijske i trombotske nuspojave prijavljene su u 4,7% bolesnika koji su primali aksitinib, uključujući infarkt miokarda (1,4%), prolaznu ishemijsku ataku (0,8%) i cerebrovaskularni incident (0,6%).
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).
Prekine li se istodobna primjena snažnog inhibitora CYP3A4/5, treba razmotriti povratak na dozu aksitiniba koja se primjenjivala prije uvođenja tog snažnog inhibitora (vidjeti dio 4.5).
Inlyta 1 mg is available in bottles of 180 tablets and blisters of 14 tablets.
Inlyta 1 mg filmom obložene tablete dostupne su u bočicama sa 180 tableta i blisterima sa 14 tableta.
• Presence of red blood cells in the urine (may show in your urine tests)
• prisutnost crvenih krvnih stanica u mokraći (može se vidjeti iz rezultata krvnih pretraga)
Major toxicity findings in mice and dogs following repeated dosing for up to 9 months were the gastrointestinal, haematopoietic, reproductive, skeletal and dental systems, with No Observed Adverse Effect Levels (NOAEL) approximately equivalent to or below expected human exposure at the recommended clinical starting dose (based on AUC levels).
No Observed Adverse Effect Levels, NOAEL) bila približno jednaka ili manja od očekivane izloženosti u ljudi kod primjene preporučene kliničke početne doze (na temelju vrijednosti AUC-a).
Arterial embolic and thrombotic eventsc,d,j
Stupanj arterijski embolijski i trombotički događaji c,
Fatal venous embolic and thrombotic events were reported 0.1% patients receiving axitinib.
Smrtonosni venski embolijski i trombotski događaji prijavljeni su u 0,1% bolesnika koji su primali aksitinib.
not statistically significant; ORR: Objective response rate; OS: Overall survival; PFS: Progression-free survival.
CI = interval pouzdanosti, HR = omjer hazarda (aksitinib/sorafenib); ITT: populacija svih uključenih bolesnika; NE: ne može se procijeniti, NS: nije statistički značajno; ORR: udio objektivnog odgovora, OS: ukupno preživljenje; PFS: preživljenje bez progresije bolesti
Fatal arterial embolic and thrombotic events were reported in 0.3% patients receiving axitinib.
Smrtonosni arterijski embolijski i trombotski događaji prijavljeni su u 0,3% bolesnika koji su primali aksitinib.
No dose adjustment is required (see sections 4.4 and 5.2).
Starije osobe (≥ 65 godina) Nije potrebno prilagođavati dozu (vidjeti dijelove 4.4 i 5.2).
b National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 c See Description of selected adverse reactions section.
Nuspojave su izvazvane liječenjem, učestalosti zbog bilo kojeg uzroka Zajednički terminološki kriteriji za nuspojave Nacionalnog instituta za rak, verzija 3.0
Ear and labyrinth disorders
Poremećaji uha i labirinta često tinitus
Grade 4 cardiac failure adverse reactions were reported in 0.6 % of patients receiving axitinib.
Nuspojave zatajenja srca stupnja 4 prijavljene su u 0,6% bolesnika koji su primali aksitinib.
Haemoglobin or haematocrit should be monitored before initiation of, and periodically throughout, treatment with axitinib.
Treba kontrolirati razinu hemoglobina i hematokrita prije početka i povremeno tijekom terapije aksitinibom.
In a controlled clinical study with axitinib for the treatment of patients with RCC, venous embolic and thrombotic adverse reactions were reported in 3.9% of patients receiving axitinib, including pulmonary embolism (2.2%), retinal vein occlusion/thrombosis (0.6%) and deep vein thrombosis (0.6%).
Venski embolijski i trombotski događaji (vidjeti dio 4.4) U kontroliranom kliničkom ispitivanju aksitiniba u terapiji bolesnika s RCC-om venski embolijski i trombotski događaji prijavljeni su u 3,9% bolesnika koji su primali aksitinib, uključujući plućnu emboliju (2,2%), okluziju/trombozu mrežnične vene (0,6%) i duboku vensku trombozu (0,6%).
If you are taking any of them, tell your doctor, pharmacist or nurse.
Ako uzimate neki od tih lijekova, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
Unchanged axitinib, accounting for 12% of the dose, was the major component identified in faeces.
Glavna komponenta utvrđena u fecesu bio je nepromijenjen aksitinib, koji je činio 12% doze.
Inlyta 1 mg: each tablet contains 1 mg axitinib
Inlyta 1 mg: jedna tableta sadrži 1 mg aksitiniba.
Inlyta 5 mg film-coated tablets Each film-coated tablet contains 5 mg of axitinib.
Inlyta 5 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 5 mg aksitiniba.
In clinical studies with axitinib 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 (see section
U kliničkim ispitivanjima aksitiniba u terapiji bolesnika s RCC-om prijavljeni su događaji zatajenja srca (uključujući zatajenje srca, kongestivno zatajenje srca, kardiopulmonalno zatajenje, poremećaj funkcije lijeve klijetke, smanjenje ejekcijske frakcije i zatajenje desne klijetke) (vidjeti dio 4.8).
Inlyta 7 mg film-coated tablets Each film-coated tablet contains 7 mg of axitinib.
Inlyta 7 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 7 mg aksitiniba.
• Muscle pain
• omaglica
Grade 4 venous embolic and thrombotic events were reported in 1.2% of patients.
Venski embolijski i trombotski događaji stupnja 4 prijavljeni su u 1,2% bolesnika.
Inlyta 5 mg: each tablet contains 5 mg axitinib
Inlyta 5 mg: jedna tableta sadrži 5 mg aksitiniba.
PHARMACEUTICAL FORM AND CONTENTS 180 tablets
180 tableta
Inlyta 7 mg: each tablet contains 7 mg axitinib
Inlyta 7 mg: jedna tableta sadrži 7 mg aksitiniba.
Specific safety events should be monitored before initiation of, and periodically throughout, treatment with axitinib as described below.
Prije početka te povremeno tijekom terapije aksitinibom treba nadzirati određene sigurnosne rizike koji su opisani u nastavku.
Inlyta 7 mg film-coated tablets are red, diamond shaped and debossed with “Pfizer” on one side and “7 XNB” on the other.
Inlyta 7 mg filmom obložene tablete su crvene i u obliku dijamanta, s utisnutom oznakom “Pfizer” na jednoj i “7 XNB” na drugoj strani.
Each film-coated tablet contains 58.8 mg of lactose monohydrate.
Inlyta 5 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 58,8 mg laktoze hidrata.
Grade 4 arterial embolic and thrombotic events were reported in 1.3% of patients.
Arterijski embolijski i trombotski događaji stupnja 4 prijavljeni su u 1,3% bolesnika.
Concomitant strong CYP3A4/5 inhibitors
Istodobna primjena snažnih inhibitora CYP3A4/5
Grade 3 arterial embolic and thrombotic events were reported in 1.2% of patients.
Arterijski embolijski i trombotski događaji stupnja 3 prijavljeni su u 1,2% bolesnika.
In clinical studies with axitinib, events of gastrointestinal perforation and fistulas were reported (see section 4.8).
Gastrointestinalne perforacije i stvaranje fistula U kliničkim ispitivanjima aksitiniba prijavljene su gastrointestinalne perforacije i fistule (vidjeti dio 4.8).
• Redness and swelling of the palms of the hands or soles of the feet (hand-foot syndrome),
• crvenilo i oticanje dlanova ili tabana (sindrom šaka i stopala), kožni osip, suha koža
In pooled clinical studies with axitinib (N = 672) for the treatment of patients with RCC, gastrointestinal perforation and fistula were reported in 1.9% of patients receiving axitinib.
U objedinjenim kliničkim ispitivanjima aksitiniba (N = 672) u terapiji bolesnika s RCC-om, gastrointestinalna perforacija i fistula prijavljeni su u 1,9% bolesnika koji su primali aksitinib.
Inlyta 3 mg: each tablet contains 3 mg axitinib
Inlyta 3 mg: jedna tableta sadrži 3 mg aksitiniba.
Concomitant strong CYP3A4/5 inducers
Istodobna primjena snažnih induktora CYP3A4/5
Inlyta 3 mg film-coated tablets Each film-coated tablet contains 3 mg of axitinib.
Inlyta 3 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 3 mg aksitiniba.
EU/1/12/777/011 56 tablets
EU/1/12/777/010 28 tableta EU/1/12/777/011 56 tableta
• Nose bleeding
• krvarenje iz nosa
Very common Palmar-plantar erythrodysaesthesia (hand-foot syndrome) Rash
Poremećaji kože i potkožnog tkiva vrlo često sindrom palmarnoplantarne eritrodizestezije (sindrom šaka i stopala) osip suha koža često svrbež eritem alopecija
Inlyta 5 mg is available in bottles of 60 tablets and blisters of 14 tablets.
Inlyta 5 mg filmom obložene tablete dostupne su u bočicama sa 60 tableta i blisterima sa 14 tableta.
Prior sunitinib treatment
Prethodno liječeni sunitinibom N=194
Grade 3/4 arterial embolic and thrombotic adverse reactions were reported in 3.3% of patients receiving axitinib.
Arterijski embolijski i trombotski događaji stupnja 3/4 prijavljeni su u 3,3% bolesnika koji su primali aksitinib.
Nervous system disorders
Poremećaj funkcije štitnjače
• Loss of appetite
• gubitak teka
Each film-coated tablet contains 82.3 mg of lactose monohydrate.
Inlyta 7 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 82,3 mg laktoze hidrata.
Grade 3/4 venous embolic and thrombotic adverse reactions were reported in 3.1% of patients receiving axitinib.
Venski embolijski i trombotski događaji stupnja 3/4 prijavljeni su u 3,1% bolesnika koji su primali aksitinib.
Inlyta 7 mg film-coated tablets
Inlyta 7 mg filmom obložene tablete
Very common Hypothyroidismc Common
Endokrini poremećaji vrlo često hipotireoza često hipertireoza
In pooled clinical studies with axitinib (N = 672) for the treatment of patients with RCC, arterial embolic and thrombotic events were reported in 2.8% of patients receiving axitinib.
U objedinjenim kliničkim ispitivanjima aksitiniba (N = 672) u terapiji bolesnika s RCC-om, arterijski embolijski i trombotski događaji prijavljeni su u 2,8% bolesnika koji su primali aksitinib.
Inlyta 7 mg is available in bottles of 60 tablets and blisters of 14 tablets.
Inlyta 7 mg filmom obložene tablete dostupne su u bočicama sa 60 tableta i blisterima sa 14 tableta.
Grade 4 haemorrhagic adverse reactions were reported in 1% of patients and fatal haemorrhage were reported in 0.4% of patients receiving axitinib.
Nuspojave krvarenja stupnja 4 prijavljene su u 1% bolesnika, a smrtonosno krvarenje prijavljeno je u 0,4% bolesnika koji su primali aksitinib.
Inlyta 7 mg film-coated tablets EU/1/12/777/010
Inlyta 7 mg filmom obložene tablete EU/1/12/777/010
In pooled clinical studies with axitinib (N = 672) for the treatment of patients with RCC, hypothyroidism was reported in 24.6% of patients receiving axitinib.
U objedinjenim kliničkim ispitivanjima aksitiniba (N = 672) u terapiji bolesnika s RCC-om, hipotireoza je prijavljena u 24,6% bolesnika koji su primali aksitinib.
Inlyta 1 mg film-coated tablets
Inlyta 1 mg filmom obložene tablete
Inlyta 5 mg film-coated tablets EU/1/12/777/004
Inlyta 5 mg filmom obložene tablete EU/1/12/777/004
In pooled clinical studies with axitinib (N = 672) for the treatment of patients with RCC, venous embolic and thrombotic events were reported in 2.8% of patients receiving axitinib.
U objedinjenim kliničkim ispitivanjima aksitiniba (N = 672) u terapiji bolesnika s RCC-om, venski embolijski i trombotski događaji prijavljeni su u 2,8% bolesnika koji su primali aksitinib.
Inlyta 1 mg film-coated tablets are red, oval and debossed with “Pfizer” on one side and “1 XNB” on the other.
Inlyta 1 mg filmom obložene tablete su crvene i ovalne, s utisnutom oznakom “Pfizer” na jednoj i “1 XNB” na drugoj strani.
Symptoms of gastrointestinal perforation or fistula should be periodically monitored for throughout treatment with axitinib.
Tijekom terapije aksitinibom treba povremeno kontrolirati prisutnost eventualnih simptoma gastrointestinalne perforacije ili fistule.
Inlyta 5 mg film-coated tablets
Inlyta 5 mg filmom obložene tablete
EU/1/12/777/008 56 tablets
EU/1/12/777/007 28 tableta EU/1/12/777/008 56 tableta
Inlyta 5 mg film-coated tablets are red, triangular and debossed with “Pfizer” on one side and “5 XNB” on the other.
Inlyta 5 mg filmom obložene tablete su crvene i trokutaste, s utisnutom oznakom “Pfizer” na jednoj i “5 XNB” na drugoj strani.
Tel: +40 (0) 21 207 28 00
Pfizer Romania S.R.L Tel: +40 (0) 21 207 28 00
Your doctor should make sure that your blood pressure is under control before starting Inlyta treatment, and while on treatment with this medicine.
Prije početka liječenja lijekom Inlyta kao i za vrijeme liječenja ovim lijekom liječnik mora biti siguran da Vam je krvni tlak pod kontrolom.
Thyroid function should be monitored before initiation of, and periodically throughout, treatment with axitinib.
Treba kontrolirati funkciju štitnjače prije početka i povremeno tijekom terapije aksitinibom.
Inlyta 1 mg film-coated tablets EU/1/12/777/001
Inlyta 1 mg filmom obložene tablete EU/1/12/777/001
Inlyta 3 mg film-coated tablets
Inlyta 3 mg filmom obložene tablete
Inlyta 3 mg film-coated tablets are red, round and debossed with “Pfizer” on one side and “3 XNB” on the other.
Inlyta 3 mg filmom obložene tablete su crvene i okrugle, s utisnutom oznakom “Pfizer” na jednoj i “3XNB” na drugoj strani.
Inlyta 3 mg film-coated tablets EU/1/12/777/007
Inlyta 3 mg filmom obložene tablete EU/1/12/777/007
Hyperbilirubinaemia Cholecystitisn
Poremećaji jetre i žuči često hiperbilirubinemija kolecistitis
In a controlled clinical study with axitinib for the treatment of patients with RCC, gastrointestinal perforation-type events were reported in 1.7% of patients receiving axitinib, including anal fistula (0.6%), fistula (0.3%) and gastrointestinal perforation (0.3%).In monotherapy studies with axitinib (N = 850), gastrointestinal perforation-type events were reported in 1.9% of patients and fatal gastrointestinal perforation was reported in one patient (0.1%).
Gastrointestinalna perforacija i stvaranje fistule (vidjeti dio 4.4) U kontroliranom kliničkom ispitivanju aksitiniba u terapiji bolesnika s RCC-om događaji tipa gastrointestinalne perforacije prijavljeni su u 1,7% bolesnika koji su primali aksitinib, uključujući analnu fistulu (0,6%), fistulu (0,3%) i gastrointestinalnu perforaciju (0,3%).
All Gradesb
Svi stupnjevi
Each film-coated tablet contains 33.6 mg of lactose monohydrate.
Inlyta 1 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 33,6 mg laktoze hidrata.
Inlyta 3 mg is available in bottles of 60 tablets and blisters of 14 tablets.
Inlyta 3mg filmom obložene tablete dostupne su u bočicama sa 60tabletai blisterima sa 14 tableta.
In pooled clinical studies with axitinib (N = 672) for the treatment of patients with RCC, polycythaemia was reported in 1.5% of patients receiving axitinib.
U objedinjenim kliničkim ispitivanjima aksitiniba (N = 672) u terapiji bolesnika s RCC-om, policitemija je prijavljena u 1,5% bolesnika koji su primali aksitinib.
Your thyroid function should be checked before you take Inlyta and regularly while you are taking it.
Liječnik Vam mora kontrolirati funkciju štitnjače prije i redovito tijekom liječenja lijekom Inlyta.
Cutoff date: 03 June 2011. b Assessed by independent radiology review according to Response Evaluation Criteria in Solid
Utvrđeno neovisnom radiološkom procjenom prema kriterijima za procjenu odgovora kod solidnih tumora (engl.
Red round film-coated tablet debossed with “Pfizer” on one side and “3 XNB” on the other.
Crvena, okrugla, filmom obložena tableta s utisnutom oznakom “Pfizer” na jednoj i “3 XNB” na drugoj strani
• An enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections).
Nepoznato: (ne može se procijeniti iz dostupnih podataka): proširenje i slabljenje stijenke krvne žile ili rascjep stijenke krvne žile (aneurizme i disekcije arterije).
METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use.
Prije uporabe pročitajte Uputu o lijeku.
Posterior reversible encephalopathy syndrome (PRES) In clinical studies with axitinib, events of PRES were reported (see section 4.8).
U kliničkim ispitivanjima aksitiniba prijavljeni su slučajevi PRES-a (vidjeti dio 4.8).
Selection of concomitant medicinal products with no or minimal CYP3A4/5 inhibition potential is recommended.
Preporučuje se odabrati popratni lijek koji nema ili ima neznatan potencijal za inhibiciju CYP3A4/5.
Thyroid dysfunction (see section 4.4)
Poremećaj funkcije štitnjače (vidjeti dio 4.4)
EU/1/12/777/002 56 tablets
EU/1/12/777/001 28 tableta EU/1/12/777/002 56 tableta
Red oval film-coated tablet debossed with “Pfizer” on one side and “1 XNB” on the other.
Crvena, ovalna, filmom obložena tableta s utisnutom oznakom “Pfizer” na jednoj i “1 XNB” na drugoj strani
Axitinib has not been studied in subjects with renal impairment.
Aksitinib nije ispitivan u bolesnika s teškim oštećenjem bubrežne funkcije.