FrancophonIA/ELRC3.0 huggingface dataset:
English: The higher dose (10 mg) was associated with a higher incidence of these adverse reactions, and peripheral oedema tended to be more severe in patients ≥65 years in short-term clinical studies (see section 4.4).
Croatian: Veća doza (10 mg) se povezivala s većom incidencijom spomenutih nuspojava, a periferni je edem češće bio teži u bolesnika u dobi od ≥ 65 godina u kratkoročnim kliničkim ispitivanjima (vidjeti dio 4.4).
English: Ambrisentan Mylan is indicated for the treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment (see section 5.1).
Croatian: Mylan je indiciran za liječenje odraslih bolesnika s plućnom arterijskom hipertenzijom (PAH) klasificiranom prema Svjetskoj zdravstvenoj organizaciji (SZO) u funkcionalni razred II do III, što uključuje i primjenu u kombiniranom liječenju (vidjeti dio 5.1).
English: The other ingredients are lactose, see section 2, ‘Ambrisentan Mylan contains lactose', microcrystalline cellulose (E460i), sodium croscarmellose, magnesium stearate (E570), polyvinyl alcohol part hydrolysed, titanium dioxide (E171), macrogol/PEG, talc (E553b), Allura red (E129), see section 2 ‘Ambrisentan Mylan contains Allura red (E129)', Indigo carmine (E132)
Croatian: Drugi sastojci su: laktoza (pogledajte dio 2, „Ambrisentan Mylan sadrži laktozu“), celuloza, mikrokristalična (E460i), umrežena karmelozanatrij, magnezijev stearat (R570), djelomično hidrolizirani poli(vinilni alkohol), titanijev dioksid (E171), makrogol/PEG, talk (E553b), boja Allura red AC Aluminium Lake (E129) (pogledajte dio 2, „Ambrisentan Mylan sadrži boju Allura red (E129)“), Indigo carmine (E132).
English: If you forget to take Ambrisentan Mylan
Croatian: Ako ste zaboravili uzeti Ambrisentan Mylan
English: Clinical efficacy in combination with tadalafil
Croatian: Klinička djelotvornost u kombinaciji s tadalafilom
English: This is a blood disorder which can cause tiredness, weakness, shortness of breath, and generally feeling unwell.
Croatian: Anemija je poremećaj krvi koji može izazvati umor, slabost, nedostatak zraka i opće loše osjećanje.
English: → Tell your doctor or pharmacist if you are taking any of these medicines.
Croatian: → Obavijestite svog liječnika ili ljekarnika ako uzimate bilo koji od navedenih lijekova.
English: Time to First Hospitalisation for Worsening PAH (Adjudicated) First hospitalisation, no
Croatian: Vrijeme do prve hospitalizacije zbog pogoršanja PAH-a (ocijenjen događaj) Prva hospitalizacija, br.
English: Ireland or
Croatian: Irska ili
English: Liver function
Croatian: Jetrena funkcija
English: A multicentre, double-blind, active comparator, event-driven, Phase 3 outcome study (AMB112565/AMBITION) was conducted to assess the efficacy of initial combination of ambrisentan and tadalafil vs. monotherapy of either ambrisentan or tadalafil alone, in 500 treatment naive PAH patients, randomised 2:1:1, respectively.
Croatian: Provedeno je multicentrično, dvostruko slijepo, aktivnim lijekom kontrolirano ispitivanje ishoda faze III vođeno događajima (AMB112565/AMBITION) radi ocjenjivanja djelotvornosti početne kombinirane terapije ambrisentom i tadalafilom u odnosu na monoterapiju ambrisentanom ili tadalafilom u 500 prethodno neliječenih bolesnika s PAH-om, koji su bili randomizirani u omjeru 2:1:1.
English: Cases consistent with autoimmune hepatitis, including possible exacerbation of underlying autoimmune hepatitis, hepatic injury and hepatic enzyme elevations potentially related to therapy have been observed with ambrisentan (see sections 4.8 and 5.1).
Croatian: Zapaženi su slučajevi koji odgovaraju autoimunom hepatitisu, uključujući moguće egzacerbacije podležećeg autoimunog hepatitisa, oštećenje jetre i porast jetrenih enzima potencijalno vezan uz liječenje ambrisentanom (vidjeti dijelove 4.8 i 5.1).
English: This change in exposure is unlikely to be of any clinical relevance and therefore ambrisentan may be co-administered with ketoconazole.
Croatian: Nije vjerojatno da ova promjena izloženosti bude od kliničkog značaja, te se stoga ambrisentan može primjenjivati istovremeno s ketokonazolom.
English: Treatment with ambrisentan led to a statistically significant improvement in Borg Dyspnea Index (BDI) at week 12 (placebo-adjusted BDI of -1.1 (95% CI: -1.8 to -0.4; p=0.019; combined dose group)).
Croatian: Liječenje ambrisentanom je dovelo do statistički značajnog poboljšanja u Borg Dyspnea Index (BDI) u 12-tom tjednu (placebo prilagođen BDI −1,1 (95% CI: −1,8 do −0,4; p=0,019; skupina kombiniranih doza)).
English: This is due to the heart not pumping out enough blood, causing shortness of breath, extreme tiredness and swelling in the ankles and legs.
Croatian: Zatajenje srca posljedica je toga što srce ne pumpa dovoljno krvi, što uzrokuje nedostatak zraka, izrazit umor te oticanje gležnjeva i nogu.
English: This is a common side effect that may affect up to one in 10 people.
Croatian: Ovo je česta nuspojava koja se može javiti u do 1 na 10 osoba.
English: → Don't breast-feed while you're taking Ambrisentan Mylan.
Croatian: →Nemojte dojiti dijete dok uzimate Ambrisentan Mylan.
English: Baseline values of hepatic aminotransferases (aspartate aminotransferases (AST) and/or alanine aminotransferases (ALT))>3xULN (see sections 4.2 and 4.4).
Croatian: Početna vrijednost jetrenih aminotransferaza (aspartat aminotransferaze (AST) i/ili alanin aminotransferaze (ALT)) > 3 × GGN (vidjeti dijelove 4.2 i 4.4).
English: When used in combination with tadalafil, Ambrisentan Mylan should be titrated to 10 mg once daily.
Croatian: Kada se primjenjuje u kombinaciji s tadalafilom, dozu lijeka Ambrisentan Mylan treba titrirati do 10 mg jednom na dan.
English: The potential for ambrisentan to induce CYP3A4 activity was explored in healthy volunteers with results suggesting a lack of inductive effect of ambrisentan on the CYP3A4 isoenzyme.
Croatian: Sposobnost ambrisentana da inducira aktivnost CYP3A4 je ispitivana u zdravih dobrovoljaca, a rezultati upućuju na zaključak da ambrisentan nema učinka na indukciju izoenzima CYP3A4.
English: The number of patients who received concomitant ambrisentan and sildenafil in ARIES-E and AMB222 was 22 patients (5.7%) and 17 patients (47%), respectively.
Croatian: Broj bolesnika koji su primali ambrisentan i sildenafil istovremeno bio je 22 (5,7%) u ARIES-E, te 17 (47%) u AMB222 ispitivanju.
English: The efficacy of ambrisentan as monotherapy has not been established in patients with WHO functional class IV PAH.
Croatian: Djelotvornost ambrisentana kao monoterapije nije utvrđena u bolesnika s PAH-om funkcionalnog razreda IV prema SZO-u.
English: Based on this pharmacokinetic study, ambrisentan would not be expected to significantly affect exposure to oestrogen- or progestogenbased contraceptives.
Croatian: Temeljem ovog farmakokinetičkog ispitivanja ne očekuje se značajan utjecaj ambrisentana na izloženost kontraceptivima koji sadrže estrogene ili progestagene.
English: A study of 492 patients (ambrisentan N=329, placebo N=163) with idiopathic pulmonary fibrosis (IPF), 11% of which had secondary pulmonary hypertension (WHO group 3), has been conducted, but was terminated early when it was determined that the primary efficacy endpoint could not be met (ARTEMIS-IPF study).
Croatian: Provođeno je ispitivanje na 492 bolesnika (ambrisentan N=329, placebo N=163) s idiopatskom plućnom fibrozom (IPF), od kojih je 11% imalo sekundarnu plućnu hipertenziju (SZO skupina 3), no isto je ranije prekinuto kada je utvrđeno da se primarni ishod djelotvornosti neće postići (ispitivanje ARTEMIS-IPF).
English: In vitro studies in rat hepatocytes also showed that ambrisentan did not induce Pgp, BSEP or MRP2 protein expression.
Croatian: In vitro ispitivanja na štakorskim hepatocitima također su pokazala da ambrisentan nije inducirao ekspresiju proteina Pgp, BSEP ni MRP2.
English: The main primary endpoints of this study were the incidence and severity of adverse events associated with long-term exposure to ambrisentan, including serum LFTs.
Croatian: Glavni primarni ishodi ovog ispitivanja bili su incidencija i težina štetnih događaja povezanih s dugotrajnom izloženošću ambrisentanu, uključujući i serumske vrijednosti pretraga funkcije jetre.
English: For dose-related adverse reactions the frequency category reflects the higher dose of ambrisentan.
Croatian: Za nuspojave ovisne o dozi, kategorija učestalosti odražava višu dozu ambrisentana.
English: If a clinically significant decrease in haemoglobin or haematocrit is observed, and other causes have been excluded, dose reduction or discontinuation of treatment should be considered.
Croatian: Ako se zapazi klinički značajno smanjenje koncentracija hemoglobina ili hematokrita, a drugi su uzroci isključeni, treba razmotriti smanjenje doze ili prekid liječenja.
English: Ambrisentan was not shown to be an inhibitor of bile acid transport or to produce overt hepatotoxicity.
Croatian: Ambrisentan se nije pokazao kao inhibitor transporta žučnih kiselina ili kao uzrok simptomatske hepatotoksičnosti.
English: With the exception of a 13% increase in sildenafil Cmax following co-administration with ambrisentan, there were no other changes in the pharmacokinetic parameters of sildenafil, N-desmethyl-sildenafil and ambrisentan.
Croatian: Osim 13%-tnog povećanja Cmax za sildenafil pri istovremenoj primjeni ambrisentana, nisu zabilježene druge promjene farmakokinetskih karakteristika sildenafila, N-dezmetil-sildenafila i ambrisentana.
English: Mean decreases from baseline (ranging from 0.9 to 1.2 g/dL) in haemoglobin concentrations persisted for up to 4 years of treatment with ambrisentan in the long-term open-label extension of the pivotal Phase 3 clinical studies.
Croatian: Srednje smanjenje od početne vrijednosti (u rasponu od 0,9 do 1,2 g/dl) u koncentracijama hemoglobina održalo se do 4 godine u liječenju ambrisentanom u dugoročnim otvorenim produžecima pivotalnih kliničkih ispitivanja faze 3.
English: The efficacy and safety of ambrisentan when co-administered with other treatments for PAH (e.g. prostanoids and soluble guanylate cyclase stimulators) has not been specifically studied in controlled clinical trials in PAH patients (see section 5.1).
Croatian: Djelotvornost i sigurnost ambrisentana pri njegovoj istovremenoj primjeni s drugim lijekovima za PAH (npr. prostanoidima i stimulatorima topljive gvanilat ciklaze) nije se specifično ispitivala u kontroliranim kliničkim ispitivanjima u bolesnika s PAH-om (vidjeti dio 5.1).
English: A food-effect study involving administration of ambrisentan to healthy volunteers under fasting conditions and with a high-fat meal indicated that the Cmax was decreased 12% while the AUC remained unchanged.
Croatian: U ispitivanju utjecaja hrane zdravi dobrovoljci primali su ambrisentan natašte i nakon obroka bogatog mastima; Cmax je bio smanjen za 12% dok je AUC ostao nepromijenjen.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti nuspojave su navedene u padajućem slijedu, prema ozbiljnosti.
English: What Ambrisentan Mylan contains
Croatian: Što Ambrisentan Mylan sadrži
English: Adverse reaction frequency categories assigned based on clinical trial experience may not reflect the frequency of adverse events occurring during normal clinical practice.
Croatian: Učestalosti nuspojava utemeljene na iskustvima kliničkih ispitivanja ne odražavaju nužno učestalosti nuspojava koje se susreću tijekom uobičajene kliničke prakse.
English: Post-marketing reports of fluid retention occurring within weeks after starting ambrisentan have been received and, in some cases, have required intervention with a diuretic or hospitalisation for fluid management or decompensated heart failure.
Croatian: Nakon stavljanja lijeka u promet zabilježeni su slučajevi pojave retencije tekućine unutar nekoliko tjedana od početka primjene ambrisentana, koji su u nekoliko slučajeva zahtijevali primjenu diuretika ili hospitalizaciju zbog retencije tekućine ili dekompenziranog zatajenja srca.
English: The active substance is ambrisentan.
Croatian: Djelatna tvar je ambrisentan.
English: 30 film-coated tablets 30x1 film-coated tablets.
Croatian: 30 filmom obloženih tableta 30×1 filmom obložena tableta
English: Fifty percent of patients had increased from 5 mg to 10 mg ambrisentan during this time.
Croatian: Pedeset posto bolesnika je tijekom tog vremena povisilo primjenjivanu dozu s 5 na 10 mg ambrisentana.
English: ARIES-1 included 201 patients and compared ambrisentan 5 mg and 10 mg with placebo.
Croatian: ARIES-1 je uključilo 201 bolesnika i uspoređivalo je ambrisentan od 5 mg i 10 mg s placebom.
English: Skin and subcutaneous tissue disorders Rash
Croatian: Poremećaji kože i potkožnog tkiva osip
English: This slight increase in sildenafil Cmax is not considered clinically relevant (see section 4.5).
Croatian: Blagi porast Cmax za sildenafil se ne smatra klinički značajnim (vidjeti dio 4.5).
English: Treatment with ambrisentan resulted in an increase in mean cardiac index, a decrease in mean pulmonary artery pressure, and a decrease in mean pulmonary vascular resistance.
Croatian: Liječenje ambrisentanom je dovelo do porasta srednjeg kardijalnog indeksa, pada srednjeg plućnog arterijskog tlaka i srednje plućne vaskularne rezistencije.
English: Co-administration of rifampicin (an inhibitor of Organic Anion Transporting Polypeptide [OATP], a strong inducer of CYP3A and 2C19, and inducer of P-gp and uridine-diphosphoglucuronosyltransferases [UGTs]) was associated with a transient (approximately 2-fold) increase in ambrisentan exposure following initial doses in healthy volunteers.
Croatian: Istovremena primjena s rifampicinom (inhibitor polipeptida koji transportira organske anione [OATP], snažni induktor CYP3A i 2C19, i induktor P-gp i uridin-difosfo-glukuronoziltransferaze [UGT]) je bila povezana sa prolaznim (približno 2 puta) povećanjem izloženosti ambrisentanu nakon početnih doza kod zdravih dobrovoljaca.
English: When co-administered with cyclosporine A, the dose of ambrisentan should be limited to 5 mg once daily and the patient should be carefully monitored (see sections 4.5 and 5.2).
Croatian: Kada se daje zajedno sa ciklosporinom A, doza ambrisentana ne smije prelaziti 5 mg jednom dnevno, a bolesnikovo stanje treba pozorno pratiti (vidjeti dijelove 4.5 i 5.2).
English: Ambrisentan has not been studied in a sufficient number of patients to establish the benefit/risk balance in WHO functional class I PAH.
Croatian: Ambrisentan nije ispitivan u dovoljnog broja bolesnika da bi se utvrdio omjer koristi i rizika u bolesnika s PAH-om funkcionalnog razreda
English: Time to First Clinical Failure Event (Adjudicated) Clinical failure, no.
Croatian: Vrijeme do prvog događaja kliničkog neuspjeha (ocijenjen događaj) Klinički neuspjeh, br.
English: In addition, the rat study showed an increased incidence of interventricular septal defects, trunk vessel defects, thyroid and thymus abnormalities, ossification of the basisphenoid bone, and the occurrence of the umbilical artery located on the left side of the urinary bladder instead of the right side.
Croatian: Uz to je u ispitivanju na štakorima opažena povećana incidencija defekata interventrikularnog septuma, abnormalnosti medijastinalnih i abdominalnih krvnih žila, abnormalnosti štitnjače i timusa, osifikacije sfenoidne kosti i smještaja umbilikalne arterije na lijevoj strani mokraćnog mjehura umjesto na desnoj strani.
English: Ambrisentan is contraindicated in pregnancy (see section 4.3).
Croatian: Primjena ambrisentana je kontraindicirana u trudnoći (vidjeti dio 4.3).
English: In patients without clinical symptoms of hepatic injury or of jaundice, re-initiation of ambrisentan may be considered following resolution of hepatic enzyme abnormalities.
Croatian: U bolesnika bez kliničkih simptoma oštećenja jetre ili žutice, ponovno uvođenje ambrisentana se može razmotriti po normalizaciji vrijednosti jetrenih enzima.
English: Exposures of ambrisentan as measured by AUC(0-inf) and Cmax were increased by 35% and 20%, respectively.
Croatian: Izloženost ambrisentanu mjerena kao AUC(0-∞) odnosno Cmax porasla je za 35% odnosno za 20%.
English: In ARIES-2, ambrisentan (combined dose group) significantly delayed the time to clinical worsening of PAH compared to placebo (p<0.001), the hazard ratio demonstrated an 80% reduction (95% CI:
Croatian: U ARIES-2, ambrisentan je (grupa s kombiniranom dozom) značajno usporio vrijeme do nastupa kliničkog pogoršanja PAH-a u odnosu na placebo (p<0,001), omjer hazarda je pokazao 80% smanjenje (95% CI: 47% do 92%).
English: There is no experience in PAH patients of ambrisentan at daily doses greater than 10 mg.
Croatian: Nema iskustva s primjenom u bolesnika s PAH-om liječenih ambrisentanom u dnevnoj dozi većoj od 10 mg.
English: Microcrystalline cellulose (E460i) Croscarmellose sodium Magnesium stearate (E570)
Croatian: Jezgra tablete laktoza celuloza, mikrokristalična (E460i) karmelozanatrij, umrežena magnezijev stearat (E570)
English: If clinically significant fluid retention develops during therapy with ambrisentan, with or without associated weight gain, further evaluation should be undertaken to determine the cause, such as ambrisentan or underlying heart failure, and the possible need for specific treatment or discontinuation of ambrisentan therapy.
Croatian: Ako se razvije klinički značajna retencija tekućine za vrijeme terapije ambrisentanom, sa ili bez posljedičnog porasta tjelesne težine, potrebna je daljnja procjena kako bi se utvrdio razlog, npr. primjena ambrisentana ili podležeće zatajenje srca, te razmotriti potrebu specifičnog liječenja ili prekida terapije ambrisentanom.
English: Nasal bone hyperplasia has not been observed with ambrisentan in mice or dogs.
Croatian: Hiperplazija nosne kosti nije primijećena kod primjene ambrisentana u miševa ili pasa.
English: After oral administration, maximum plasma concentrations (Cmax) of ambrisentan typically occur around 1.5 hours post-dose under both fasted and fed conditions.
Croatian: Nakon peroralne primjene ambrisentan postiže maksimalnu koncentraciju u plazmi (Cmax) oko 1,5 h nakon primjene doze i natašte i nakon obroka.
English: • yellowing of your skin or the whites of your eyes (jaundice)
Croatian: • žutilo kože ili bjeloočnica (žutica)
English: Furthermore, ambrisentan did not induce MRP2, Pgp or BSEP protein expression in rat hepatocytes.
Croatian: Osim toga, ambrisentan nije inducirao ekspresiju proteina MRP2, P-gp ni BSEP na štakorskim hepatocitima.
English: → If it is possible you could become pregnant, use a reliable form of birth control (contraception) while you're taking Ambrisentan Mylan.
Croatian: Ako postoji mogućnost da zatrudnite koristite pouzdanu metodu zaštite od začeća (kontracepciju) tijekom terapije lijekom Ambrisentan Mylan.
English: Ambrisentan is a substrate for Pgp-mediated efflux.
Croatian: Ambrisentan je supstrat za Pgp-om posredovan efluks.
English: In placebo controlled clinical trials of 12 weeks duration mean reduction in systolic and diastolic blood pressures from base line to end of treatment were 3 mm Hg and 4.2 mm Hg respectively.
Croatian: U 12-tjednim placebom kontroliranim kliničkim ispitivanjima, srednja vrijednost smanjenja sistoličkog odnosno dijastoličkog krvnog tlaka od početnih vrijednosti pa do kraja terapije bila je 3 mmHg odnosno 4,2 mmHg.
English: Co-administration of ambrisentan with a phosphodiesterase inhibitor, either sildenafil or tadalafil (both substrates of CYP3A4) in healthy volunteers did not significantly affect the pharmacokinetics of the phosphodiesterase inhibitor or ambrisentan (see section 5.2).
Croatian: Istovremena primjena ambrisentana i inhibitora fosfodiesteraze kao što su sildenafil ili tadalafil (oba supstrati CYP3A4) u zdravih dobrovoljaca nije značajno utjecala na farmakokinetiku inhibitora fosfodiesteraze ili ambrisentana (vidjeti dio 5.2).
English: When used in combination with tadalafil, patients were initiated with 5 mg ambrisentan and 20 mg tadalafil.
Croatian: Kod primjene u kombinaciji s tadalafilom, liječenje bolesnika započelo je dozom od 5 mg ambrisentana i 20 mg tadalafila.
English: In a population pharmacokinetic analysis, creatinine clearance was found to be a statistically significant covariate affecting the oral clearance of ambrisentan.
Croatian: U analizama populacijske farmakokinetike, klirens kreatinina se pokazao statistički značajnom kovarijancom koja utječe na oralni klirens ambrisentana.
English: Ambrisentan is therefore contraindicated for patients with IPF with or without secondary pulmonary hypertension (see section 4.3).
Croatian: Stoga je ambrisentan kontraindiciran u liječenju bolesnika s IPF-om sa ili bez sekundarne plućne hipertenzije (vidjeti dio 4.3).
English: Autoimmune hepatitis (see section 4.4)
Croatian: autoimuni hepatitis (vidjeti dio 4.4) manje često
English: If you take more Ambrisentan Mylan than you should If you take too many tablets you may be more likely to have side effects, such as headache, flushing, dizziness, nausea (feeling sick), or low blood pressure that could cause light-headedness:
Croatian: Ako uzmete previše tableta, veća je vjerojatnost pojave nuspojava poput glavobolje, navala crvenila, omaglice, mučnine ili niskog krvnog tlaka koji može izazvati ošamućenost.
English: • lung disease where the veins in the lungs are blocked (pulmonary veno-occlusive disease).
Croatian: • ako imate plućnu bolest kod koje dolazi do začepljenja vena u plućima (plućna venookluzivna bolest)
English: The mean decreases in systolic and diastolic blood pressures persisted for up to 4 years of treatment with ambrisentan in the long-term open label ARIES E study.
Croatian: Srednje vrijednosti smanjenja sistoličkog i dijastoličkog krvnog tlaka zadržane su do 4 godine liječenja ambrisentanom u dugoročnom otvorenom ispitivanju ARIES E.
English: Patients with WHO FC II and III had a mean baseline 6MWD of 353 metres.
Croatian: Bolesnici s bolešću funkcionalnog razreda II i III prema SZO-u imali su srednju početnu vrijednost 6MWD od 353 metara.
English: • liver injury
Croatian: • oštećenje jetre
English: Each tablet contains approximately 26 mg of lactose and 10 micrograms of Allura red AC Aluminium lake
Croatian: Jedna tableta sadrži približno 26 mg laktoze i 10 mikrograma boje Allura red AC Aluminium lake.
English: Severe hepatic impairment (with or without cirrhosis) (see section 4.2).
Croatian: Teško oštećenje jetre (sa ili bez ciroze) (vidjeti dio 4.2).
English: Monthly pregnancy tests during treatment with ambrisentan are recommended (see sections 4.3 and 4.6).
Croatian: Preporučuje se i mjesečno provoditi test na trudnoću tijekom primjene ambrisentana (vidjeti dijelove 4.3 i 4.6).
English: Fluid retention
Croatian: Retencija tekućine
English: Sudden hearing loss
Croatian: iznenadan gubitak sluha
English: Ear and labyrinth disorders Tinnitus
Croatian: Poremećaji uha i labirinta tinitus
English: Ambrisentan is an orally active, propanoic acid-class, ERA selective for the endothelin A (ETA) receptor.
Croatian: Ambrisentan je peroralno aktivni antagonist endotelinskih receptora selektivan za endotelin A (ETA) receptor, iz skupine propanoatne kiseline.
English: The increase in digoxin exposure observed in the presence of multiple doses of ambrisentan was not considered clinically relevant, and no dose adjustment of digoxin is warranted (see section 4.5).
Croatian: Povećanje izloženosti digoksinu primijećeno u prisustvu višekratnog doziranja ambrisentana se ne smatra klinički značajnim, te nije sigurna potreba prilagodbe doze digoksina (vidjeti dio 4.5).
English: In vitro data indicate that ambrisentan at 300 μM resulted in less than 50% inhibition of UGT1A1, UGT1A6, UGT1A9, UGT2B7 (up to 30%) or of cytochrome P450 enzymes 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4 (up to 25%).
Croatian: In vitro podaci pokazuju da je ambrisentan u koncentraciji od 300 µM uzrokovao ˂ 50% inhibiciju UGT1A1, UGT1A6, UGT1A9, UGT2B7 (do 30%) ili enzima citokroma P450: 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 i 3A4 (do 25%).