FrancophonIA/ELRC3.0 huggingface dataset:
English: Pink, capsule shaped, biconvex film-coated tablet with ‘M' debossed on one side and ‘AN1' on the other, approximately 9.9 mm long and 4.8 mm wide.
Croatian: Ružičasta, bikonveksna filmom obložena tableta u obliku kapsule, s utisnutom oznakom „M” na jednoj i „AN” na drugoj strani, dužine približno 9,9 mm i širine 4,8 mm.
English: Each tablet contains approximately 52 mg of lactose and 20 micrograms of Allura red AC Aluminium lake
Croatian: Jedna tableta sadrži približno 52 mg laktoze i 20 mikrograma boje Allura red AC Aluminium lake.
English: However, multiple doses of ambrisentan had no clinically relevant effect on cyclosporine A exposure, and no dose adjustment of cyclosporine A is warranted.
Croatian: Međutim, višekratne doze ambrisentana nisu imale relevantan klinički značaj na izloženost ciklosporinu A, stoga nije potrebna prilagodba doze ciklosporina A.
English: Ambrisentan Mylan is supplied as 5 mg and 10 mg film-coated tablets in packs of 30 tablets and unit dose blister packs of 30x1 tablets.
Croatian: Mylan je dostupan u obliku filmom obloženih tableta od 5 mg i 10 mg u pakiranjima od 30 tableta ili blister pakiranjima djeljivima na jedinične doze s 30x1 tabletom.
English: Ambrisentan blocks the ETA receptor subtype, localized predominantly on vascular smooth muscle cells and cardiac myocytes.
Croatian: Ambrisentan blokira ETA podvrstu receptora, smještenu uglavnom na glatkim mišićnim stanicama krvnih žila i kardiomiocitima.
English: In a population pharmacokinetic analysis, the oral clearance was shown to be decreased as a function of increasing bilirubin levels.
Croatian: U analizama populacijske farmakokinetike, smanjenje oralnog klirensa se pokazalo proporcionalno vrijednostima bilirubina.
English: Based on the results of a population pharmacokinetic analysis in healthy volunteers and patients with PAH, the pharmacokinetics of ambrisentan were not significantly influenced by gender or age (see section 4.2).
Croatian: Temeljem rezultata analize farmakokinetike u populaciji zdravih dobrovoljaca i bolesnika s PAH-om, starosna dob i spol ne utječu značajno na farmakokinetiku ambrisentana (vidjeti dio 4.2).
English: If patients develop sustained, unexplained, clinically significant ALT and/or AST elevation, or if ALT and/or AST elevation is accompanied by signs or symptoms of hepatic injury (e.g. jaundice), ambrisentan therapy should be discontinued.
Croatian: Ako se zabilježi trajno, neobjašnjeno, klinički značajno povišenje AST i/ili ALT ili je ono praćeno kliničkim znakovima i simptomima jetrenog oštećenja (npr. žutica), terapiju ambrisentanom treba prekinuti.
English: NT-proBNP (% reduction)
Croatian: N-terminal proBrain Natriuremic Peptide) (% smanjenja)
English: Patients with pre-existent hepatic disease (cirrhosis or clinically significantly elevated aminotransferases) and patients using other targeted therapy for PAH (e.g. prostanoids) were excluded.
Croatian: U ispitivanje nisu bili uključeni bolesnici s prethodno postojećom bolešću jetre (ciroza ili klinički značajno povišene aminotransferaze), kao ni bolesnici na drugoj ciljanoj terapiji za PAH (npr. prostanoidima).
English: However, by day 8, steady state administration of rifampicin had no clinically relevant effect on ambrisentan exposure.
Croatian: Ipak, do dana 8, uporaba rifampicina u stanju dinamičke ravnoteže nije imala klinički značajan učinak na izloženost ambrisentanu.
English: In the post-marketing period, cases of anaemia requiring blood cell transfusion have been reported (see section 4.8).
Croatian: Nakon stavljanja lijeka u promet prijavljeni su slučajevi anemije koja je zahtijevala transfuziju krvnih stanica (vidjeti dio 4.8).
English: In the post-marketing period, cases of anaemia requiring blood cell transfusion have been reported (see section 4.4).
Croatian: Nakon stavljanja lijeka u promet prijavljeni su slučajevi anemije koja je zahtijevala transfuziju krvnih stanica (vidjeti dio 4.4).
English: • anaemia (a reduced number of red blood cells)
Croatian: • ako imate anemiju (smanjen broj crvenih krvnih stanica)
English: Therefore, hepatic aminotransferases (ALT and AST) should be evaluated prior to initiation of ambrisentan and treatment should not be initiated in patients with baseline values of ALT and/or AST >3xULN (see section 4.3).
Croatian: Stoga je potrebno prekontrolirati vrijednosti jetrenih aminotransferaza (AST i ALT) prije uvođenja ambrisentana te liječenje ne treba započinjati u bolesnika u kojih su početne vrijednosti ALT i/ili AST > 3× GGN (vidjeti dio 4.3).
English: → It is important that you have these regular blood tests for as long as you are taking Ambrisentan Mylan.
Croatian: → Važno je da redovito provodite krvne pretrage za vrijeme liječenja lijekom Ambrisentan Mylan.
English: The frequency of decreased haemoglobin (anaemia) was higher with 10 mg ambrisentan.
Croatian: Učestalost snižavanja hemoglobina (anemija) je bila veća pri primjeni 10 mg ambrisentana.
English: Steady-state administration of ketoconazole (a strong inhibitor of CYP3A4) did not result in a clinically significant increase in exposure to ambrisentan (see section 5.2).
Croatian: Primjena ketokonazola (snažni inhibitor CYP3A4) u stanju dinamičke ravnoteže nije rezultirala klinički značajnim povećanjem izloženosti ambrisentanu (vidjeti dio 5.2).
English: Women receiving ambrisentan must be advised of the risk of foetal harm and alternative therapy initiated if pregnancy occurs (see sections 4.3, 4.4 and 5.3).
Croatian: Žene koje primaju ambrisentan mora se upozoriti na rizik od fetalnih oštećenja, te se u slučaju trudnoće mora započeti sa zamjenskim oblicima liječenja (vidjeti dijelove 4.3, 4.4 i 5.3).
English: Hypersensitivity reactions (e.g. angioedema, rash, pruritus)
Croatian: Poremećaji imunološkog sustava reakcije preosjetljivosti (npr. angioedem, osip, svrbež)
English: Poly(vinyl alcohol) (partly hydrolysed) Titanium dioxide (E171) Macrogol
Croatian: Film ovojnica poli(vinil alkohol) (djelomično hidroliziran) titanijev dioksid (E171) makrogol talk (E553b)
English: The pharmacokinetics of ambrisentan in patients with hepatic impairment (with or without cirrhosis) has not been studied.
Croatian: Farmakokinetika ambrisentana u bolesnika s oštećenjem jetrene funkcije (sa ili bez ciroze), nije ispitivana.
English: Ambrisentan had no effects on the steady-state pharmacokinetics and anti-coagulant activity of warfarin in a healthy volunteer study (see section 5.2).
Croatian: Ambrisentan nije imao učinka na farmakokinetiku u stanju dinamičke ravnoteže i antikoagulantnu aktivnost varfarina u ispitivanju na zdravim dobrovoljcima (vidjeti dio 5.2).
English: Chronic administration of ambrisentan was not associated with a change in plasma testosterone in clinical studies.
Croatian: Prema kliničkim ispitivanjima, kronična primjena ambrisentana nije povezana s promjenama koncentracije testosterona u plazmi.
English: Decrease in systolic and diastolic blood pressures has been reported with ambrisentan therapy.
Croatian: Prijavljeno je smanjenje sistoličkog i dijastoličkog krvnog tlaka kod terapije ambrisentanom.
English: Therefore, ambrisentan must not be initiated in patients with severe hepatic impairment, or clinically significant elevated hepatic aminotransferases (greater than 3 times the Upper Limit of Normal (>3xULN); see sections 4.3 and 4.4).
Croatian: Zbog toga se terapija ambrisentanom ne smije započinjati u bolesnika s teškim oštećenjem jetre ili klinički značajnim povišenjem jetrenih aminotransferaza (više od 3 puta iznad gornje granice normalnih vrijednosti (> 3 × GGN); vidjeti dijelove 4.3 i 4.4).
English: This decrease in peak concentration is not clinically significant, and therefore ambrisentan can be taken with or without food.
Croatian: Ovo smanjenje vršne koncentracije nije klinički značajno te se ambrisentan može uzimati neovisno o obroku.
English: Haemodynamic parameters were not assessed in these studies.
Croatian: U ovom ispitivanju nisu procjenjivani hemodinamski pokazatelji.
English: Contains lactose and Allura red AC Aluminium Lake (E129).
Croatian: Sadrži laktozu i boju Allura red AC Aluminium Lake (E129).
English: In combination with tadalafil
Croatian: U kombinaciji s tadalafilom
English: Most cases of peripheral oedema in clinical studies with ambrisentan were mild to moderate in severity, although it may occur with greater frequency and severity in patients ≥65 years.
Croatian: Tijekom kliničkih ispitivanja većina je perifernih edema bila blaga do umjerena, ali oni mogu biti češći i teži u bolesnika u dobi
English: The distribution of ambrisentan into red blood cells is low, with a mean blood: plasma ratio of 0.57 and 0.61 in males and females, respectively.
Croatian: Raspodjela ambrisentana u eritrocite je mala; srednji omjer distribucije između krvi i plazme iznosi 0,57 za muškarce i 0,61 za žene.
English: Patients started on ambrisentan 5 mg and tadalafil 20 mg and were titrated to 40 mg tadalafil at week 4 and 10 mg ambrisentan at week 8, unless there were tolerability issues.
Croatian: Bolesnici su započeli liječenje ambrisentanom u dozi od 5 mg i tadalafilom u dozi od 20 mg, nakon čega je doza tadalafila titrirana do 40 mg u 4. tjednu, a doza ambrisentana do 10 mg u 8. tjednu, pod uvjetom da nije bilo nikakvih problema s podnošljivošću.
English: You can take Ambrisentan Mylan with or without food.
Croatian: Ambrisentan Mylan možete uzeti neovisno o obroku.
English: • inflammation of the liver caused by the body's own defences (autoimmune hepatitis) In combination with tadalafil
Croatian: • upala jetre koju uzrokuje vlastiti imunološki sustav (autoimuni hepatitis).
English: Across the 12 week placebo-controlled Phase 3 clinical studies, mean haemoglobin concentrations decreased for patients in the ambrisentan groups and were detected as early as week 4 (decrease by 0.83 g/dL); mean changes from baseline appeared to stabilise over the subsequent 8 weeks.
Croatian: Tijekom 12 tjedana placebom kontrolirane faze 3 kliničkih ispitivanja srednja vrijednost koncentracije hemoglobina za bolesnike u grupi na ambrisentanu se smanjila (smanjenje za 0,83 g/dl), a zamijećena je već u četvrtom tjednu ispitivanja; srednje vrijednosti odstupanja od osnovne vrijednosti su se stabilizirale tijekom sljedećih 8 tjedana.
English: Reductions in haemoglobin concentrations and haematocrit have been associated with endothelin receptor antagonists (ERAs) including ambrisentan.
Croatian: Smanjenje koncentracije hemoglobina i hematokrita povezano je s primjenom antagonista endotelinskih receptora, pa tako i ambrisentana.
English: In vitro, ambrisentan has no inhibitory effect on human transporters at clinically relevant concentrations, including Pgp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3 and NTCP.
Croatian: In vitro, ambrisentan u klinički značajnim koncentracijama ne inhibira humane prijenosnike, uključujući Pgp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3 ni NTCP.
English: Ambrisentan in combination with tadalafil
Croatian: Ambrisentan u kombinaciji s tadalafilom
English: It is not known if Ambrisentan Mylan is transferred to breast milk.
Croatian: Nije poznato izlučuje li se Ambrisentan Mylan u majčino mlijeko.
English: In a clinical study in healthy volunteers, steady-state dosing with ambrisentan 10 mg once daily did not significantly affect the single-dose pharmacokinetics of the ethinyl estradiol and norethindrone components of a combined oral contraceptive (see section 5.2).
Croatian: U kliničkom ispitivanju na zdravim dobrovoljcima primjena ambrisentana u stanju dinamičke ravnoteže u dozi od 10 mg jednom dnevno nije pokazala značajan utjecaj na farmakokinetiku jedne doze kombiniranih oralnih kontraceptiva koji sadržavaju etinilestradiol ili noretindron (vidjeti dio 5.2).
English: Frequency categories do not account for other factors including varying study duration, pre-existing conditions and baseline patient characteristics.
Croatian: Kategorije učestalosti ne uključuju druge čimbenike kao što su trajanje ispitivanja, već postojeće bolesti i karakteristike bolesnika na početku uključivanja u ispitivanje.
English: Ambrisentan Mylan 10 mg film-coated tablet (tablet) is a pink, capsule shaped tablet engraved with ‘M' on one side of the tablet and ‘AN1' on the other side.
Croatian: Ambrisentan Mylan 10 mg filmom obložena tableta (tableta) je ružičasta tableta u obliku kapsule s utisnutom oznakom „M” na jednoj i „AN” na drugoj strani tablete.
English: • swelling in the hands, ankles or feet caused by fluid (peripheral oedema)
Croatian: • ako Vam zbog nakupljanja tekućine otiču šake, gležnjevi ili stopala (periferni edem)
English: In vitro, ambrisentan has no inhibitory effect on human transporters at clinically relevant concentrations, including the P-glycoprotein (Pgp), breast cancer resistance protein (BCRP), multidrug resistance related protein 2 (MRP2), bile salt export pump (BSEP), organic anion transporting polypeptides (OATP1B1 and OATP1B3) and the sodium-dependent taurocholate co-transporting polypeptide (NTCP).
Croatian: In vitro, ambrisentan u klinički značajnim koncentracijama nema inhibitorni učinak na humane prijenosnike, uključujući P-glikoprotein (Pgp), protein koji uzrokuje rezistenciju raka dojke na lijekove (BCRP, engl. breast cancer resistance protein), protein povezan s rezistencijom na više lijekova 2 (MRP2, engl. multi-drug resistance related protein 2), pumpu za izlučivanje žučnih soli (BSEP, engl. bile salt export pump), polipeptide koji transportiraju organske anione (OATP1B1 i OATP1B3, engl.
English: The incidence of anaemia was increased when ambrisentan was dosed in combination with tadalafil (15% adverse event frequency), compared to the incidence of anaemia when ambrisentan and tadalafil were given as monotherapy (7% and 11%, respectively).
Croatian: Kada se ambrisentan primjenjivao u kombinaciji s tadalafilom, incidencija anemije bila je povećana (učestalost štetnog događaja: 15%) u odnosu na incidenciju anemije kada su se ambrisentan i tadalafil primjenjivali u monoterapiji (7% odnosno 11%).
English: Ambrisentan Mylan treatment must not be initiated in women of child-bearing potential unless the result of a pre-treatment pregnancy test is negative and reliable contraception is practiced.
Croatian: Liječenje lijekom Ambrisentan Mylan u žena reproduktivne dobi smije se započeti samo ako je rezultat testa na trudnoću napravljen prije samog početka liječenja bio negativan, a žena koristi pouzdane metode kontracepcije.
English: The selectivity of ambrisentan for the ETA over the ETB receptor is expected to retain ETB receptor mediated production of the vasodilators nitric oxide and prostacyclin.
Croatian: Zbog selektivnosti ambrisentana za ETA receptore u odnosu na ETB receptore, očekuje se održano stvaranje vazodilatatora - dušikovog oksida i prostaciklina, posredovano ETB receptorima.
English: The placeboadjusted mean improvement in 6MWD was 44.6 m (95% CI: 24.3 to 64.9; p<0.001) for the 5 mg dose, and 52.5 m (95% CI: 28.8 to 76.2; p<0.001) for the 10 mg dose.
Croatian: Placebom prilagođeno srednje poboljšanje 6MWD je iznosilo 44,6 m (95% CI: 24,3 do 64,9; p<0,001) za dozu od 5 mg, a 52,5 m (95% CI: 28,8 do 76,2; p<0,001) za dozu od 10 mg.
English: Steady-state co-administration of ambrisentan and cyclosporine A resulted in a 2-fold increase in ambrisentan exposure in healthy volunteers.
Croatian: Istovremena primjena ambrisentana i ciklosporina A u stanju dinamičke ravnoteže prouzročila je dvostruko povišenu izloženost ambrisentanu u zdravih dobrovoljaca.
English: Pink, round, biconvex film-coated tablet with ‘M' debossed on one side and ‘AN' on the other, approximately 5.7 mm in diameter.
Croatian: Ružičasta, okrugla, bikonveksna filmom obložena tableta s utisnutom oznakom „M” na jednoj i „AN” na drugoj strani, promjera približno 5,7 mm.
English: No dose adjustment is required in patients with renal impairment (see section 5.2).
Croatian: Nije potrebna prilagodba doze u bolesnika s oštećenjem bubrega (vidjeti dio 5.2).
English: Decreased haemoglobin
Croatian: Snižene vrijednosti hemoglobina
English: The placebo-adjusted improvement in mean 6MWD at week 12 in patients in the 10 mg group in ARIES-1 was 51.4 m (95% CI: 26.6 to 76.2; p<0.001).
Croatian: Placebom prilagođeno srednje poboljšanje 6MWD u 12-tom tjednu, u bolesnika na 10 mg u ARIES-1 je iznosilo 51,4 m (95% CI: 26,6 do 76,2; p<0,001).
English: This causes people to feel tired, dizzy and short of breath.
Croatian: Zbog toga bolesnici osjećaju umor, omaglicu i nedostatak zraka.
English: Steady-state administration of ambrisentan in healthy volunteers had no clinically relevant effects on the single-dose pharmacokinetics of digoxin, a substrate for Pgp (see section 5.2).
Croatian: Primjena ambrisentana u stanju dinamičke ravnoteže u zdravih dobrovoljaca nije imala klinički značajan učinak na farmakokinetiku pojedinačne doze digoksina, supstrata Pgp-a (vidjeti dio 5.2).
English: The primary endpoint defined for the Phase 3 studies was improvement in exercise capacity assessed by change from baseline in 6minute walk distance (6MWD) at 12 weeks.
Croatian: Primarni ishod ispitivanja definiran za fazu 3 ispitivanja, bio je poboljšanje podnošenja napora procijenjeno nakon 12 tjedana testom šestominutnog hoda (6MWD; engl.
English: The incidence of peripheral oedema was increased when ambrisentan was dosed in combination with tadalafil (45% adverse event frequency), compared to the incidence of peripheral oedema when ambrisentan and tadalafil were given as monotherapy (38% and 28%, respectively).
Croatian: Kada se ambrisentan primjenjivao u kombinaciji s tadalafilom, incidencija perifernog edema bila je povećana (učestalost štetnog događaja: 45%) u odnosu na incidenciju perifernog edema kada su se ambrisentan i tadalafil primjenjivali u monoterapiji (38% odnosno 28%).
English: Therapy that is recommended at the severe stage of the disease (e.g. epoprostenol) should be considered if the clinical condition deteriorates.
Croatian: Ako dođe do pogoršanja kliničkog stanja, treba razmisliti o primjeni terapije preporučene za teški stadij ove bolesti (npr. epoprostenola).
English: The effects of repeat dosing of ambrisentan (10 mg) on the pharmacokinetics of single dose digoxin were studied in 15 healthy volunteers.
Croatian: Učinak ponavljanih doza ambrisentana (10 mg) na farmakokinetiku pojedinačne doze digoksina je proučavan na 15 zdravih dobrovoljaca.
English: Hepatic transaminases increased
Croatian: porast vrijednosti jetrenih transaminaza
English: Taken together, the in vitro data suggest ambrisentan at clinically relevant concentrations (plasma Cmax up to 3.2 μM) would not be expected to have an effect on UGT1A1, UGT1A6, UGT1A9, UGT2B7 or cytochrome P450 enzymes 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4 or transport via BSEP, BCRP, Pgp, MRP2, OATP1B1/3, or NTCP.
Croatian: Sveukupno, in vitro podaci ukazuju da ambrisentan u klinički značajnim koncentracijama (Cmax u plazmi do 3,2 µM) ne bi trebao imati učinak na UGT1A1, UGT1A6, UGT1A9, UGT2B7, na enzime citokroma P450: 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4 niti na transport putem BSEP-a, BCRP-a, Pgp-a, MRP2, OATP1B1/3 ili NTCP-a.
English: Treatment with combination therapy resulted in a 50% risk reduction (hazard ratio [HR] 0.502; 95% CI: 0.348 to 0.724; p=0.0002) of the composite clinical failure endpoint up to final assessment visit when compared to the pooled monotherapy group [Figure 1 and Table 1].
Croatian: U usporedbi s objedinjenim podacima iz skupina liječenih monoterapijom, liječenje kombiniranom terapijom smanjilo je rizik od kompozitne mjere ishoda - kliničkog neuspjeha - za 50% (omjer hazarda [engl. hazard ratio, HR]: 0,502; 95% CI: 0,348 - 0,724; p=0,0002) do posljednjeg kontrolnog posjeta [Slika 1 i Tablica 1].
English: The effects of 12 days dosing with ambrisentan (10 mg once daily) on the pharmacokinetics of a single dose of oral contraceptive containing ethinyl estradiol (35 μg) and norethindrone (1 mg) were studied in healthy female volunteers.
Croatian: Ispitivan je utjecaj 12-dnevne primjene ambrisentana (10 mg jednom dnevno) na farmakokinetiku pojedinačne doze oralnih kontraceptiva koji sadržavaju etinilestradiol (35 µg) i noretindron (1 mg) na zdravim dobrovoljkama.
English: In dogs, slight inflammatory responses were observed following chronic high dose administration of ambrisentan at exposures greater than 20-fold that observed in patients.
Croatian: U pasa su zapaženi blagi upalni odgovori pri 20 puta većoj izloženosti od one u bolesnika.
English: This may be due to the inhibition by cyclosporine A of transporters and metabolic enzymes involved in the pharmacokinetics of ambrisentan.
Croatian: To je vjerojatno posljedica inhibicije transportera i metaboličkih enzima uključenih u farmakokinetiku ambrisentana od strane ciklosporina A. Stoga, doza ambrisentana kod istovremene primjene sa ciklosporinom
English: The effect was significant for both FC II and FC III patients.
Croatian: Učinak je bio značajan i za bolesnike s bolešću funkcionalnog razreda II i za one s bolešću funkcionalnog razreda III.
English: It is not known whether ambrisentan is excreted in human breast milk.
Croatian: Nije poznato izlučuje li se ambrisentan u majčino mlijeko u ljudi.
English: Ambrisentan treatment must not be initiated in women of child-bearing potential unless the result of a pre-treatment pregnancy test is negative and reliable contraception is practiced.
Croatian: Liječenje ambrisentanom u žena reproduktivne dobi smije se započeti samo ako je rezultat testa na trudnoću napravljenog prije samog početka liječenja bio negativan, a žena koristi pouzdane metode kontracepcije.
English: How to store Ambrisentan Mylan
Croatian: Kako čuvati Ambrisentan Mylan
English: This can cause light-headedness.
Croatian: Hipotenzija može izazvati ošamućenost.
English: Ambrisentan is glucuronidated via several UGT isoenzymes (UGT1A9S, UGT2B7S and UGT1A3S) to form ambrisentan glucuronide (13%).
Croatian: Glukuronidacija do ambrisentan-glukuronida (13%) se odvija putem nekoliko izoenzima uridilglukuronid transferaza - UGT (UGT1A9S, UGT2B7S i UGT1A3S).
English: Therefore, ambrisentan should not be initiated in patients with severe hepatic impairment or clinically significant elevated hepatic aminotransferases (>3xULN) (see sections 4.3 and 4.4).
Croatian: Stoga se ne preporučuje uvođenje ambrisentana u bolesnika s teškim oštećenjem jetre ili klinički značajnim porastom jetrenih aminotransferaza (> 3 × GGN) (vidjeti dio 4.3 i 4.4).
English: However, caution should be used in patients with severe renal impairment (see section 4.2).
Croatian: Ipak se preporučuje oprez pri primjeni kod bolesnika s teškim bubrežnim oštećenjem (vidjeti dio 4.2).
English: How to take Ambrisentan Mylan
Croatian: Kako uzimati Ambrisentan Mylan
English: The clinical status of the patient and the adverse reaction profile of ambrisentan (such as hypotension, dizziness, asthenia, fatigue) should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills (see section 4.8).
Croatian: Kada se razmatra bolesnikova sposobnost izvođenja aktivnosti koje zahtijevaju prosuđivanje te motoričke ili kognitivne vještine, treba imati na umu klinički status bolesnika i profil nuspojava uzrokovanih primjenom ambrisentana (poput hipotenzije, omaglice, astenije i umora) (vidjeti dio 4.8).
English: Ambrisentan does not undergo significant renal metabolism or renal clearance (excretion).
Croatian: Ambrisentan se značajno ne metabolizira niti se uklanja bubregom (izlučuje).
English: Similarly, co-administration with warfarin did not affect the pharmacokinetics of ambrisentan (see section 4.5).
Croatian: Slično tome, niti varfarin ne utječe na farmakokinetiku ambrisentana (vidjeti dio 4.5).
English: How much Ambrisentan Mylan to take
Croatian: Koliko lijeka Ambrisentan Mylan uzeti