FrancophonIA/ELRC3.0 huggingface dataset:
English: If a strong CYP3A4/5 inhibitor must be co-administered, a dose adjustment of axitinib is recommended (see section 4.2).
Croatian: Mora li se istodobno primijeniti snažan inhibitor CYP3A4/5, preporučuje se prilagoditi dozu aksitiniba (vidjeti dio 4.2).
English: 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.
Croatian: 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.
English: • Increase in the number of red blood cells (may show in your blood tests)
Croatian: • povećan broj crvenih krvnih stanica (može se vidjeti iz rezultata krvnih pretraga)
English: Liver function tests should be monitored before initiation of, and periodically throughout, treatment with axitinib.
Croatian: Treba kontrolirati rezultate testova funkcije jetre prije početka i povremeno tijekom terapije aksitinibom.
English: • Protein in the urine (may show in your urine tests)
Croatian: • proteini u mokraći (mogu se vidjeti iz rezultata krvnih pretraga)
English: Cardiac failure eventsc,d,f
Croatian: Srčani poremećaji često događaji zatajenja srca c,d,f
English: • Reduction in the number of red blood cells (may show in your blood tests)
Croatian: • smanjen broj crvenih krvnih stanica (može se vidjeti iz rezultata krvnih pretraga)
English: INFORMATION IN BRAILLE Inlyta 5 mg
Croatian: Inlyta 5 mg
English: 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).
Croatian: 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).
English: Kaplan-Meier curve of progression-free survival by independent assessment for the prior cytokine subgroup
Croatian: Slika 3: Kaplan-Meierova krivulja preživljenja bez progresije bolesti prema neovisnoj procjeni za podskupinu prethodno liječenu citokinom
English: Maximal induction with high-dose strong CYP3A4/5 inducers has been reported to occur within one week of treatment with the inducer.
Croatian: Zabilježeno je da maksimalna indukcija nastupa u roku od tjedan dana terapije visokom dozom jakih induktora CYP3A4/5.
English: Very common Arthralgia Pain in extremity
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva vrlo često artralgija bol u ekstremitetima često mialgija
English: Fatal cardiac failure was reported in 0.6 % of patients receiving axitinib.
Croatian: Smrtonosno zatajenje srca prijavljeno je u 0,6% bolesnika koji su primali aksitinib.
English: 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%).
Croatian: 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%).
English: 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).
Croatian: 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).
English: Inlyta 1 mg is available in bottles of 180 tablets and blisters of 14 tablets.
Croatian: Inlyta 1 mg filmom obložene tablete dostupne su u bočicama sa 180 tableta i blisterima sa 14 tableta.
English: • Presence of red blood cells in the urine (may show in your urine tests)
Croatian: • prisutnost crvenih krvnih stanica u mokraći (može se vidjeti iz rezultata krvnih pretraga)
English: 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).
Croatian: 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).
English: Arterial embolic and thrombotic eventsc,d,j
Croatian: Stupanj arterijski embolijski i trombotički događaji c,
English: Fatal venous embolic and thrombotic events were reported 0.1% patients receiving axitinib.
Croatian: Smrtonosni venski embolijski i trombotski događaji prijavljeni su u 0,1% bolesnika koji su primali aksitinib.
English: not statistically significant; ORR: Objective response rate; OS: Overall survival; PFS: Progression-free survival.
Croatian: 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
English: Fatal arterial embolic and thrombotic events were reported in 0.3% patients receiving axitinib.
Croatian: Smrtonosni arterijski embolijski i trombotski događaji prijavljeni su u 0,3% bolesnika koji su primali aksitinib.
English: No dose adjustment is required (see sections 4.4 and 5.2).
Croatian: Starije osobe (≥ 65 godina) Nije potrebno prilagođavati dozu (vidjeti dijelove 4.4 i 5.2).
English: INFORMATION IN BRAILLE Inlyta 3 mg
Croatian: Inlyta 3 mg
English: b National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 c See Description of selected adverse reactions section.
Croatian: Nuspojave su izvazvane liječenjem, učestalosti zbog bilo kojeg uzroka Zajednički terminološki kriteriji za nuspojave Nacionalnog instituta za rak, verzija 3.0
English: Ear and labyrinth disorders
Croatian: Poremećaji uha i labirinta često tinitus
English: Grade 4 cardiac failure adverse reactions were reported in 0.6 % of patients receiving axitinib.
Croatian: Nuspojave zatajenja srca stupnja 4 prijavljene su u 0,6% bolesnika koji su primali aksitinib.
English: Haemoglobin or haematocrit should be monitored before initiation of, and periodically throughout, treatment with axitinib.
Croatian: Treba kontrolirati razinu hemoglobina i hematokrita prije početka i povremeno tijekom terapije aksitinibom.
English: 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%).
Croatian: 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%).
English: If you are taking any of them, tell your doctor, pharmacist or nurse.
Croatian: Ako uzimate neki od tih lijekova, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
English: Unchanged axitinib, accounting for 12% of the dose, was the major component identified in faeces.
Croatian: Glavna komponenta utvrđena u fecesu bio je nepromijenjen aksitinib, koji je činio 12% doze.
English: Inlyta 1 mg: each tablet contains 1 mg axitinib
Croatian: Inlyta 1 mg: jedna tableta sadrži 1 mg aksitiniba.
English: Inlyta 5 mg film-coated tablets Each film-coated tablet contains 5 mg of axitinib.
Croatian: Inlyta 5 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 5 mg aksitiniba.
English: 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
Croatian: 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).
English: Inlyta 7 mg film-coated tablets Each film-coated tablet contains 7 mg of axitinib.
Croatian: Inlyta 7 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 7 mg aksitiniba.
English: • Muscle pain
Croatian: • omaglica
English: Grade 4 venous embolic and thrombotic events were reported in 1.2% of patients.
Croatian: Venski embolijski i trombotski događaji stupnja 4 prijavljeni su u 1,2% bolesnika.
English: Inlyta 5 mg: each tablet contains 5 mg axitinib
Croatian: Inlyta 5 mg: jedna tableta sadrži 5 mg aksitiniba.
English: PHARMACEUTICAL FORM AND CONTENTS 180 tablets
Croatian: 180 tableta
English: Inlyta 7 mg: each tablet contains 7 mg axitinib
Croatian: Inlyta 7 mg: jedna tableta sadrži 7 mg aksitiniba.
English: Specific safety events should be monitored before initiation of, and periodically throughout, treatment with axitinib as described below.
Croatian: Prije početka te povremeno tijekom terapije aksitinibom treba nadzirati određene sigurnosne rizike koji su opisani u nastavku.
English: Inlyta 7 mg film-coated tablets are red, diamond shaped and debossed with “Pfizer” on one side and “7 XNB” on the other.
Croatian: Inlyta 7 mg filmom obložene tablete su crvene i u obliku dijamanta, s utisnutom oznakom “Pfizer” na jednoj i “7 XNB” na drugoj strani.
English: Each film-coated tablet contains 58.8 mg of lactose monohydrate.
Croatian: Inlyta 5 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 58,8 mg laktoze hidrata.
English: Grade 4 arterial embolic and thrombotic events were reported in 1.3% of patients.
Croatian: Arterijski embolijski i trombotski događaji stupnja 4 prijavljeni su u 1,3% bolesnika.
English: Concomitant strong CYP3A4/5 inhibitors
Croatian: Istodobna primjena snažnih inhibitora CYP3A4/5
English: Grade 3 arterial embolic and thrombotic events were reported in 1.2% of patients.
Croatian: Arterijski embolijski i trombotski događaji stupnja 3 prijavljeni su u 1,2% bolesnika.
English: In clinical studies with axitinib, events of gastrointestinal perforation and fistulas were reported (see section 4.8).
Croatian: Gastrointestinalne perforacije i stvaranje fistula U kliničkim ispitivanjima aksitiniba prijavljene su gastrointestinalne perforacije i fistule (vidjeti dio 4.8).
English: • Redness and swelling of the palms of the hands or soles of the feet (hand-foot syndrome),
Croatian: • crvenilo i oticanje dlanova ili tabana (sindrom šaka i stopala), kožni osip, suha koža
English: 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.
Croatian: 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.
English: Inlyta 3 mg: each tablet contains 3 mg axitinib
Croatian: Inlyta 3 mg: jedna tableta sadrži 3 mg aksitiniba.
English: Concomitant strong CYP3A4/5 inducers
Croatian: Istodobna primjena snažnih induktora CYP3A4/5
English: Inlyta 3 mg film-coated tablets Each film-coated tablet contains 3 mg of axitinib.
Croatian: Inlyta 3 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 3 mg aksitiniba.
English: EU/1/12/777/011 56 tablets
Croatian: EU/1/12/777/010 28 tableta EU/1/12/777/011 56 tableta
English: • Nose bleeding
Croatian: • krvarenje iz nosa
English: Very common Palmar-plantar erythrodysaesthesia (hand-foot syndrome) Rash
Croatian: Poremećaji kože i potkožnog tkiva vrlo često sindrom palmarnoplantarne eritrodizestezije (sindrom šaka i stopala) osip suha koža često svrbež eritem alopecija
English: Inlyta 5 mg is available in bottles of 60 tablets and blisters of 14 tablets.
Croatian: Inlyta 5 mg filmom obložene tablete dostupne su u bočicama sa 60 tableta i blisterima sa 14 tableta.
English: Prior sunitinib treatment
Croatian: Prethodno liječeni sunitinibom N=194
English: Grade 3/4 arterial embolic and thrombotic adverse reactions were reported in 3.3% of patients receiving axitinib.
Croatian: Arterijski embolijski i trombotski događaji stupnja 3/4 prijavljeni su u 3,3% bolesnika koji su primali aksitinib.
English: Nervous system disorders
Croatian: Poremećaj funkcije štitnjače
English: • Loss of appetite
Croatian: • gubitak teka
English: Each film-coated tablet contains 82.3 mg of lactose monohydrate.
Croatian: Inlyta 7 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 82,3 mg laktoze hidrata.
English: Grade 3/4 venous embolic and thrombotic adverse reactions were reported in 3.1% of patients receiving axitinib.
Croatian: Venski embolijski i trombotski događaji stupnja 3/4 prijavljeni su u 3,1% bolesnika koji su primali aksitinib.
English: Inlyta 7 mg film-coated tablets
Croatian: Inlyta 7 mg filmom obložene tablete
English: Very common Hypothyroidismc Common
Croatian: Endokrini poremećaji vrlo često hipotireoza često hipertireoza
English: 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.
Croatian: 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.
English: Inlyta 7 mg is available in bottles of 60 tablets and blisters of 14 tablets.
Croatian: Inlyta 7 mg filmom obložene tablete dostupne su u bočicama sa 60 tableta i blisterima sa 14 tableta.
English: Grade 4 haemorrhagic adverse reactions were reported in 1% of patients and fatal haemorrhage were reported in 0.4% of patients receiving axitinib.
Croatian: Nuspojave krvarenja stupnja 4 prijavljene su u 1% bolesnika, a smrtonosno krvarenje prijavljeno je u 0,4% bolesnika koji su primali aksitinib.
English: Inlyta 7 mg film-coated tablets EU/1/12/777/010
Croatian: Inlyta 7 mg filmom obložene tablete EU/1/12/777/010
English: 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.
Croatian: U objedinjenim kliničkim ispitivanjima aksitiniba (N = 672) u terapiji bolesnika s RCC-om, hipotireoza je prijavljena u 24,6% bolesnika koji su primali aksitinib.
English: Inlyta 1 mg film-coated tablets
Croatian: Inlyta 1 mg filmom obložene tablete
English: Inlyta 5 mg film-coated tablets EU/1/12/777/004
Croatian: Inlyta 5 mg filmom obložene tablete EU/1/12/777/004
English: 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.
Croatian: 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.
English: Inlyta 1 mg film-coated tablets are red, oval and debossed with “Pfizer” on one side and “1 XNB” on the other.
Croatian: Inlyta 1 mg filmom obložene tablete su crvene i ovalne, s utisnutom oznakom “Pfizer” na jednoj i “1 XNB” na drugoj strani.
English: Symptoms of gastrointestinal perforation or fistula should be periodically monitored for throughout treatment with axitinib.
Croatian: Tijekom terapije aksitinibom treba povremeno kontrolirati prisutnost eventualnih simptoma gastrointestinalne perforacije ili fistule.
English: Inlyta 5 mg film-coated tablets
Croatian: Inlyta 5 mg filmom obložene tablete
English: EU/1/12/777/008 56 tablets
Croatian: EU/1/12/777/007 28 tableta EU/1/12/777/008 56 tableta
English: Inlyta 5 mg film-coated tablets are red, triangular and debossed with “Pfizer” on one side and “5 XNB” on the other.
Croatian: Inlyta 5 mg filmom obložene tablete su crvene i trokutaste, s utisnutom oznakom “Pfizer” na jednoj i “5 XNB” na drugoj strani.
English: Tel: +40 (0) 21 207 28 00
Croatian: Pfizer Romania S.R.L Tel: +40 (0) 21 207 28 00
English: Your doctor should make sure that your blood pressure is under control before starting Inlyta treatment, and while on treatment with this medicine.
Croatian: Prije početka liječenja lijekom Inlyta kao i za vrijeme liječenja ovim lijekom liječnik mora biti siguran da Vam je krvni tlak pod kontrolom.
English: Thyroid function should be monitored before initiation of, and periodically throughout, treatment with axitinib.
Croatian: Treba kontrolirati funkciju štitnjače prije početka i povremeno tijekom terapije aksitinibom.
English: Inlyta 1 mg film-coated tablets EU/1/12/777/001
Croatian: Inlyta 1 mg filmom obložene tablete EU/1/12/777/001
English: Inlyta 3 mg film-coated tablets
Croatian: Inlyta 3 mg filmom obložene tablete
English: Inlyta 3 mg film-coated tablets are red, round and debossed with “Pfizer” on one side and “3 XNB” on the other.
Croatian: Inlyta 3 mg filmom obložene tablete su crvene i okrugle, s utisnutom oznakom “Pfizer” na jednoj i “3XNB” na drugoj strani.
English: Inlyta 3 mg film-coated tablets EU/1/12/777/007
Croatian: Inlyta 3 mg filmom obložene tablete EU/1/12/777/007
English: Hyperbilirubinaemia Cholecystitisn
Croatian: Poremećaji jetre i žuči često hiperbilirubinemija kolecistitis
English: 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%).
Croatian: 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%).
English: All Gradesb
Croatian: Svi stupnjevi
English: Each film-coated tablet contains 33.6 mg of lactose monohydrate.
Croatian: Inlyta 1 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 33,6 mg laktoze hidrata.
English: Inlyta 3 mg is available in bottles of 60 tablets and blisters of 14 tablets.
Croatian: Inlyta 3mg filmom obložene tablete dostupne su u bočicama sa 60tabletai blisterima sa 14 tableta.
English: 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.
Croatian: U objedinjenim kliničkim ispitivanjima aksitiniba (N = 672) u terapiji bolesnika s RCC-om, policitemija je prijavljena u 1,5% bolesnika koji su primali aksitinib.
English: Your thyroid function should be checked before you take Inlyta and regularly while you are taking it.
Croatian: Liječnik Vam mora kontrolirati funkciju štitnjače prije i redovito tijekom liječenja lijekom Inlyta.
English: Cutoff date: 03 June 2011. b Assessed by independent radiology review according to Response Evaluation Criteria in Solid
Croatian: Utvrđeno neovisnom radiološkom procjenom prema kriterijima za procjenu odgovora kod solidnih tumora (engl.
English: Red round film-coated tablet debossed with “Pfizer” on one side and “3 XNB” on the other.
Croatian: Crvena, okrugla, filmom obložena tableta s utisnutom oznakom “Pfizer” na jednoj i “3 XNB” na drugoj strani
English: • An enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections).
Croatian: Nepoznato: (ne može se procijeniti iz dostupnih podataka): proširenje i slabljenje stijenke krvne žile ili rascjep stijenke krvne žile (aneurizme i disekcije arterije).
English: METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use.
Croatian: Prije uporabe pročitajte Uputu o lijeku.
English: Posterior reversible encephalopathy syndrome (PRES) In clinical studies with axitinib, events of PRES were reported (see section 4.8).
Croatian: U kliničkim ispitivanjima aksitiniba prijavljeni su slučajevi PRES-a (vidjeti dio 4.8).
English: Selection of concomitant medicinal products with no or minimal CYP3A4/5 inhibition potential is recommended.
Croatian: Preporučuje se odabrati popratni lijek koji nema ili ima neznatan potencijal za inhibiciju CYP3A4/5.
English: Thyroid dysfunction (see section 4.4)
Croatian: Poremećaj funkcije štitnjače (vidjeti dio 4.4)
English: EU/1/12/777/002 56 tablets
Croatian: EU/1/12/777/001 28 tableta EU/1/12/777/002 56 tableta
English: Red oval film-coated tablet debossed with “Pfizer” on one side and “1 XNB” on the other.
Croatian: Crvena, ovalna, filmom obložena tableta s utisnutom oznakom “Pfizer” na jednoj i “1 XNB” na drugoj strani
English: Axitinib has not been studied in subjects with renal impairment.
Croatian: Aksitinib nije ispitivan u bolesnika s teškim oštećenjem bubrežne funkcije.
English: In pooled clinical studies with axitinib (N = 672) for the treatment of patients with RCC, haemorrhagic events were reported in 25.7% of patients receiving axitinib.
Croatian: U objedinjenim kliničkim ispitivanjima aksitiniba (N = 672) u terapiji bolesnika s RCC-om, krvarenja su prijavljena u 25,7% bolesnika koji su primali aksitinib.
English: Vascular disorders Very common Hypertensiong Haemorrhagec,d,h
Croatian: Krvožilni poremećaji vrlo često hipertenzija krvarenje c, d,h često venski embolijski i trombotički događaji c,
English: Red diamond shaped film-coated tablet debossed with “Pfizer” on one side and “7 XNB” on the other.
Croatian: Crvena, romboidna, filmom obložena tableta s utisnutom oznakom “Pfizer” na jednoj i “7 XNB” na drugoj strani
English: EU/1/12/777/005 56 tablets
Croatian: EU/1/12/777/004 28 tableta EU/1/12/777/005 56 tableta
English: Each film-coated tablet contains 35.3 mg of lactose monohydrate.
Croatian: Inlyta 3 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 35,3 mg laktoze hidrata.
English: Red triangular film-coated tablet debossed with “Pfizer” on one side and “5 XNB” on the other.
Croatian: Crvena, trokutasta, filmom obložena tableta s utisnutom oznakom “Pfizer” na jednoj i “5 XNB” na drugoj strani
English: Selection of concomitant medicinal products with no or minimal CYP3A4/5 induction potential is recommended.
Croatian: Preporučuje se odabrati popratni lijek koji nema ili ima neznatan potencijal za indukciju CYP3A4/5.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 1 mg axitinib.
Croatian: Jedna filmom obložena tableta sadrži 1 mg aksitiniba.
English: Lipase increased
Croatian: Prijavljivanje nuspojava
English: Selection of an alternate concomitant medicinal product with no or minimal CYP3A4/5 inhibition potential is recommended.
Croatian: Preporučuje se odabrati drugi popratni lijek koji nema ili ima neznatan potencijal za inhibiciju CYP3A4/5.
English: NAME OF THE MEDICINAL PRODUCT Inlyta 7 mg film-coated tablets axitinib
Croatian: Inlyta 7 mg filmom obložene tablete aksitinib
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Inlyta 1 mg film-coated tablets Each film-coated tablet contains 1 mg of axitinib.
Croatian: Inlyta 1 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 1 mg aksitiniba.
English: Vivian Corporation Ltd. Tel: +356 21344610
Croatian: Pfizer Biofarmacêutica, Sociedade Unipessoal Lda Tel: +351 21 423 5500
English: NAME OF THE MEDICINAL PRODUCT Inlyta 1 mg film-coated tablets axitinib
Croatian: Inlyta 1 mg filmom obložene tablete aksitinib