FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the magnitude of effect of bilirubin is modest (compared to the typical patient with a bilirubin of 0.6 mg/dl, a patient with an elevated bilirubin of 4.5 mg/dl would have approximately 30% lower oral clearance of ambrisentan).
Croatian: Međutim, jačina učinka bilirubina je umjerena (u usporedbi s tipičnim bolesnikom s bilirubinom od 0,6 mg/dl, bolesnik s povišenim bilirubinom od 4,5 mg/dl će imati otprilike 30% manji oralni klirens ambrisentana).
English: The mean age of all patients was 54 years (SD 15; range 18-75 years of age).
Croatian: Srednja vrijednost dobi svih bolesnika bila je 54 godine (standardno odstupanje: 15; raspon: 18 do 75 godina).
English: The MAH will agree the distribution plan with the National Competent Authorities before the product launch in each territory and will ensure that all patients taking Ambrisentan Mylan have been provided with the relevant educational materials.
Croatian: Nositelj odobrenja će prije stavljanja lijeka na tržište u svakoj državi članici dogovoriti plan distribucije s nadležnim nacionalnim regulatornim tijelom te će osigurati da svi bolesnici koji uzimaju Ambrisentan Mylan dobiju odgovarajuće edukacijske materijale.
English: If you are a woman who could become pregnant, your doctor will ask you to take a pregnancy test before you start taking Ambrisentan Mylan and regularly while you are taking this medicine.
Croatian: Ako ste žena koja može začeti, liječnik će Vas zamoliti da napravite test na trudnoću prije početka liječenja ovim lijekom, ali i redovito za vrijeme trajanja liječenja.
English: Pulmonary veno-occlusive disease
Croatian: Plućna venookluzivna bolest
English: During a mean of 53 weeks of treatment with ambrisentan, none of the patients enrolled had a confirmed serum ALT >3xULN that required permanent discontinuation of treatment.
Croatian: Tijekom srednjeg razdoblja od 53 tjedna liječenja ambrisentanom niti u jednog uključenog bolesnika nije potvrđen serumski ALT > 3× GGN koji bi zahtijevao trajan prekid liječenja.
English: Hazard ratio (95% CI) P-value, Log-rank test
Croatian: Omjer hazarda (95% CI) P-vrijednost, log-rang test
English: • a runny nose
Croatian: • curenje nosa
English: • sudden hearing loss.
Croatian: • iznenadan gubitak sluha.
English: The binding affinity of 4-hydroxymethyl ambrisentan for the human endothelin receptor is 65-fold less than ambrisentan.
Croatian: Afinitet vezanja 4-hidroksimetil ambrisentana za humani endotelinski receptor je 65 puta manja od afiniteta ambrisentana.
English: The usual dose of Ambrisentan Mylan is one 5 mg tablet, once a day.
Croatian: Uobičajena doza lijeka Ambrisentan Mylan je jedna tableta od 5 mg, jednom dnevno.
English: In people with PAH, these arteries get narrower, so the heart has to work harder to pump blood through them.
Croatian: Kod ljudi s PAH-om ove arterije su sužene, zbog čega srce mora raditi snažnije kako bi protisnulo krv kroz njih.
English: The measure included: death, lung transplantation, hospitalisation for PAH, atrial septostomy, addition of other PAH therapeutic agents and early escape criteria.
Croatian: Mjereni su: smrt, transplantacija pluća, hospitalizacija zbog PAH-a, septostomija atrija, dodavanje drugih lijekova za PAH i kriteriji ranog uzmaka.
English: Each film-coated tablet contains 5 mg or 10 mg.
Croatian: Jedna filmom obložena tableta sadrži 5 ili 10 mg.
English: A total of 17 patients (6.5%) in the ambrisentan treatment groups had decreases in haemoglobin of ≥15% from baseline and which fell below the lower limit of normal.
Croatian: Ukupno 17 bolesnika (6,5%) u grupi liječenoj ambrisentanom je imalo zabilježen pad hemoglobina ≥ 15% od početne vrijednosti, što je bilo ispod donje granice normale.
English: Nervous system disorders Headache (including sinus headache, migraine)
Croatian: Poremećaji živčanog sustava glavobolja (uključujući sinusnu glavobolju i migrenu)
English: Testicular tubular atrophy, which was occasionally associated with aspermia, was observed in oral repeat dose toxicity and fertility studies with male rats and mice without safety margin.
Croatian: Atrofija tubula u testisu, katkad povezana s aspermijom, nađena je u ispitivanjima toksičnosti ponavljanih oralnih doza i ispitivanjima plodnosti na mužjacima štakora i miševa bez sigurnosnih granica.
English: Eye disorders Blurred vision, visual impairment
Croatian: Poremećaji oka zamagljen vid, oštećenje vida nepoznato
English: If there is any doubt on what contraceptive advice should be given to the individual patient, consultation with a gynaecologist should be considered.
Croatian: U slučaju dvojbe o primjeni pojedinih metoda kontracepcije, predlaže se konzultacija ginekologa.
English: At baseline, 96% of patients were naive to any previous PAH-specific treatment, and the median time from diagnosis to entry into the study was 22 days.
Croatian: Na početku ispitivanja 96% bolesnika prethodno nije primalo nikakvo liječenje specifično za PAH, a medijan vremena od dijagnoze do uključivanja u ispitivanje iznosio je 22 dana.
English: In both studies, treatment with ambrisentan resulted in a significant improvement in 6MWD for each dose of ambrisentan.
Croatian: U oba ispitivanja liječenje ambrisentanom je rezultiralo značajnim poboljšanjem 6MWD za svaku od ispitivanih doza ambrisentana.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Blisteri
English: • itching of your skin.
Croatian: • svrbež kože.
English: Cmax and area under the plasma concentration-time curve (AUC) increase dose proportionally over the therapeutic dose range.
Croatian: Cmax i površina ispod krivulje ovisnosti koncentracije u plazmi o vremenu (AUC) povisuju proporcionalno dozu u terapijskom rasponu doza.
English: Due to the class primary pharmacologic effect, a large single dose of ambrisentan (i.e. an overdose) could lower arterial pressure and have the potential for causing hypotension and symptoms related to vasodilation.
Croatian: S obzirom na primarni farmakološki učinak skupine, jedna velika doza ambrisentana (tj. predoziranje), mogla bi sniziti arterijski tlak i prouzročiti hipotenziju i simptome vezane uz vazodilataciju.
English: Routine pharmacovigilance data are also presented.
Croatian: Prikazani su i podaci dobiveni tijekom rutinskog farmakovigilancijskog praćenja.
English: • abnormal blood test results for liver function
Croatian: • poremećeni nalazi krvnih pretraga za funkciju jetre
English: Other medicines and Ambrisentan Mylan
Croatian: Drugi lijekovi i Ambrisentan Mylan
English: No dose adjustment is required in patients over the age of 65 (see section 5.2).
Croatian: Nije potrebna prilagodba doze u bolesnika starijih od 65 godina (vidjeti dio 5.2).
English: In juvenile rats administered ambrisentan orally once daily during postnatal day 7 to 26, 36 or 62, a decrease in brain weight (−3% to -8%) with no morphologic or neurobehavioral changes occurred after breathing sounds, apnoea and hypoxia were observed.
Croatian: U mladih štakora kojima je ambrisentan primijenjivan peroralno jednom dnevno tijekom perioda od 7. do 26., 36. ili 62. postnatalnog dana, nakon uočenih zvukova disanja, apneje i hipoksije zabilježeno je smanjenje težine mozga (−3% do −8%), bez morfoloških ili neurobihevioralnih promjena.
English: In male rats, there were no effects of ambrisentan on sperm motility at all doses tested (up to 300 mg/kg/day).
Croatian: Nije bilo učinaka ambrisentana na pokretljivost spermija mužjaka štakora pri svim ispitivanim dozama (do 300 mg/kg/dan).
English: Ambrisentan Mylan is to be taken orally to begin at a dose of 5 mg once daily and may be increased to 10 mg daily depending upon clinical response and tolerability.
Croatian: Mylan se uzima peroralno u početnoj dozi od 5 mg jednom na dan, koja se može povećati na 10 mg na dan, ovisno o kliničkom odgovoru i podnošljivosti.
English: The excretion of ambrisentan in milk has not been studied in animals.
Croatian: Izlučivanje ambrisentana u mlijeko nije ispitivano u životinja.
English: Ambrisentan has been shown to be teratogenic in rats and rabbits.
Croatian: Ambrisentan je teratogen za štakore i kuniće.
English: Consequently, if PAH patients develop acute pulmonary oedema when treated with ambrisentan, the possibility of pulmonary veno-occlusive disease should be considered.
Croatian: Posljedično, ako bolesnici s PAH-om razviju akutni plućni edem tijekom terapije ambrisentanom, treba se uzeti u obzir mogućnost postojanja plućne venookluzivne bolesti.
English: In the AMBITION study, patients received 5 mg ambrisentan daily for the first 8 weeks before up titrating to 10 mg, dependent on tolerability (see section 5.1).
Croatian: U ispitivanju AMBITION, bolesnici su primali 5 mg ambrisentana na dan tijekom prvih 8 tjedana, nakon čega se doza titrira do 10 mg, ovisno o podnošljivosti (vidjeti dio 5.1).
English: Concomitant use with other medicinal products
Croatian: Istovremena terapija drugim lijekovima
English: There was a small increase in mammary fibroadenomas, a benign tumor, in male rats at the highest dose only.
Croatian: Pronađen je mali porast fibroadenoma mliječne žlijezde (benigni tumor) kod mužjaka štakora samo pri najvišim dozama.
English: In an open label study (AMB222), ambrisentan was studied in 36 patients to evaluate the incidence of increased serum aminotransferase concentrations in patients who had previously discontinued other ERA therapy due to aminotransferase abnormalities.
Croatian: U otvorenom ispitivanju (AMB222), ambrisentan je ispitivan na 36 bolesnika radi evaluacije incidencije porasta koncentracije serumskih aminotransferaza, u bolesnika koji su prethodno prekinuli terapiju drugim ERA-om zbog abnormalnosti koncentracija aminotransferaza.
English: Ambrisentan does not inhibit or induce phase I or II drug metabolising enzymes at clinically relevant concentrations in in vitro and in vivo non-clinical studies, suggesting a low potential for ambrisentan to alter the profile of medicinal products metabolised by these pathways.
Croatian: Ambrisentan ne inhibira niti inducira enzime faze I ili II metabolizma lijekova u klinički značajnim koncentracijama u in vitro i in vivo nekliničkim ispitivanjima, što sugerira malu sposobnost ambrisentana u mijenjanju svojstva lijekova koji se metaboliziraju na ovaj način.
English: In the ARIES-E open label long term extension study, the 2 year risk of developing serum aminotransferase elevations >3xULN in patients treated with ambrisentan was 3.9%.
Croatian: U otvorenom dugoročnom produženom ispitivanju ARIES-E, dvogodišnji rizik od razvoja povećanih serumskih razina aminotransferaze > 3× GGN u bolesnika liječenih ambrisentanom bio je 3,9%.
English: Following initial doses of rifampicin, a transient increase in ambrisentan AUC(0-τ) (121% and 116% after first and second doses of rifampicin, respectively) was observed, presumably due to a rifampicin-mediated OATP inhibition.
Croatian: Nakon početnih doza rifampicina pronađen je prolazni porast AUC(0-τ) ambrisentana (121% u prvoj i 116% nakon druge doze rifampicina), vjerojatno zbog inhibicije OATP od strane rifampicina.
English: In both studies, ambrisentan was added to patients' supportive/background medication, which could have included a combination of digoxin, anticoagulants, diuretics, oxygen and vasodilators (calcium channel blockers, ACE inhibitors).
Croatian: U oba ispitivanja ambrisentan je pridodan suportivnim/postojećim lijekovima, koji su mogli uključivati kombinaciju digoksina, antikoagulansa, diuretika, kisika i vazodilatatora (blokatori kalcijevih kanala, ACE inhibitori).
English: Monthly pregnancy tests during treatment with ambrisentan are recommended.
Croatian: Preporučuje se i mjesečno provoditi test na trudnoću tijekom primjene ambrisentana.
English: The effect of ambrisentan on male human fertility is not known.
Croatian: Učinak ambrisentana na plodnost muškaraca nije poznat.
English: The observed probability of survival for subjects receiving ambrisentan (combined ambrisentan dose group) at 1, 2 and 3 years was 93%, 85% and 79% respectively.
Croatian: Zapažena vjerojatnost preživljenja za ispitanike koji su primali ambrisentan (skupina kombiniranih doza ambrisentana), nakon 1, 2 odnosno 3 godine je iznosila 93%, 85% odnosno 79%.
English: Due to the mechanism of action, an overdose of ambrisentan could potentially result in hypotension (see section 5.3).
Croatian: S obzirom na mehanizam djelovanja, predoziranje ambrisentanom može potencijalno rezultirati i hipotenzijom (vidjeti dio 5.3).
English: What you need to know before you take Ambrisentan Mylan
Croatian: Što morate znati prije nego počnete uzimati Ambrisentan Mylan
English: The occurrence of peripheral oedema was highest within the first month of treatment initiation.
Croatian: Periferni edem najčešće se javljao unutar prvih mjesec dana nakon početka liječenja.
English: Approximately 22% of the administered dose is recovered in the urine following oral administration with 3.3% being unchanged ambrisentan.
Croatian: Otprilike 22% peroralno primijenjene doze nađeno je u urinu, od čega je 3,3% neizmijenjeni ambrisentan.
English: Multiple doses of ambrisentan resulted in slight increases in digoxin AUC0-last and trough concentrations, and a 29% increase in digoxin Cmax.
Croatian: Višestruke doze ambrisentana rezultirale su blagim povećanjem AUC0-last i vršnih koncentracija te 29%-nim povećanjem Cmax za digoksin.
English: Most of these decreases were detected during the first 4 weeks of treatment and haemoglobin generally stabilised thereafter.
Croatian: Većina takvih događaja je zabilježena tijekom prva 4 tjedna liječenja, nakon čega je došlo do stabilizacije vrijednosti hemoglobina.
English: In addition, in patients, ambrisentan had no overall effect on the weekly warfarin-type anticoagulant dose, prothrombin time (PT) and international normalised ratio (INR).
Croatian: Uz to, u bolesnika, ambrisentan sveukupno nije imao učinak na tjednu dozu antikoagulansa varfarinskog tipa, kao ni na protrombinsko vrijeme (PV) i internacionalni normalizirani omjer (INR).
English: It is recommended that the tablet should not be split, crushed or chewed.
Croatian: Preporučuje se ne lomiti, drobiti ni žvakati tabletu.
English: Steady-state is generally achieved following 4 days of repeat dosing.
Croatian: Stanje dinamičke ravnoteže se općenito postiže nakon 4 dana uzastopne primjene lijeka.
English: These changes in exposure to ethinyl estradiol or norethindrone were small and are unlikely to be clinically significant (see section 4.5).
Croatian: Ove promjene u izloženosti etinilestradiolu i noretindronu su male i ne očekuje se da budu klinički značajne (vidjeti dio 4.5).
English: Ambrisentan and its metabolites are eliminated primarily in the bile following hepatic and/or extrahepatic metabolism.
Croatian: Ambrisentan i njegovi metaboliti se eliminiraju prvenstveno putem žuči, nakon metaboliziranja u jetri i/ili izvan nje.
English: Other targeted PAH treatments
Croatian: Drugi ciljani lijekovi za PAH
English: No data are available (see section 5.3 regarding data available in juvenile animals).
Croatian: Nema dostupnih kliničkih podataka (za dostupne podatke u mladih životinja, vidjeti dio 5.3).
English: Information from longer term non-placebo-controlled studies (ARIES-E and AMBITION
Croatian: Navedeni su i podaci iz dugoročnih ispitivanja koja nisu bila kontrolirana placebom (ARIES-E i AMBITION (kombinacija s tadalafilom)).
English: Dependent on tolerability the dose of tadalafil was increased to 40 mg after 4 weeks and the dose of ambrisentan was increased to 10 mg after 8 weeks.
Croatian: Ovisno o podnošljivosti, doza tadalafila se povećala na 40 mg nakon 4 tjedna, a doza ambrisentana na 10 mg nakon 8 tjedana.
English: Systemic exposure to ambrisentan in male rats at this dose (based on steady-state AUC) was 6-fold that achieved at the 10 mg/day clinical dose.
Croatian: Sistemska izloženost ambrisentanu kod mužjaka štakora pri toj dozi (temeljeno na AUC u stanju dinamičke ravnoteže) bila je 6 puta veća od one postignute pri kliničkoj dozi od 10 mg/dan.
English: • That Ambrisentan Mylan is teratogenic in animals
Croatian: • da je Ambrisentan Mylan teratogen za životinje
English: This is a very common side effect that may affect more than one in 10 people.
Croatian: Ovo je vrlo česta nuspojava koja se može javiti u više od 1 na 10 osoba.
English: Secondary endpoints were tested:
Croatian: Ispitivale su se i sekundarne mjere ishoda:
English: Patients enrolled had IPAH or PAH associated with connective tissue disease (PAH-CTD).
Croatian: Uključeni bolesnici su bolovali od IPAH-a ili PAH-a povezanog s bolešću vezivnog tkiva (PAH-CTD).
English: • Patient Reminder Card
Croatian: • Kartica s podsjetnikom za bolesnike
English: Ambrisentan is highly plasma protein bound.
Croatian: Ambrisentan se u visokoj mjeri veže na proteine plazme.
English: Idiopathic pulmonary fibrosis (IPF), with or without secondary pulmonary hypertension (see section 5.1).
Croatian: Idiopatska plućna fibroza (IPF) sa ili bez sekundarne plućne hipertenzije (vidjeti dio 5.1).
English: Limited data suggest that the abrupt discontinuation of ambrisentan is not associated with rebound worsening of PAH.
Croatian: Ograničeni broj podataka upućuje da nagli prekid liječenja ambrisentanom nije povezan s ponovnim pogoršanjem PAH-a.
English: Anaemia (reduced number of red blood cells)
Croatian: Anemija (smanjen broj crvenih krvnih stanica)
English: Efficacy of combination therapy on the primary endpoint was consistent on the comparison to individual monotherapy and across the subgroups of age, ethnic origin, geographical region, aetiology (iPAH/hPAH and PAH-CTD).
Croatian: Djelotvornost kombinirane terapije s obzirom na primarnu mjeru ishoda bila je konzistentna kada se uspoređivala s pojedinom monoterapijom, kao i u podskupinama prema dobi, etničkom podrijetlu, geografskoj regiji i etiologiji (idiopatski PAH/nasljedni PAH i PAH povezan s bolešću vezivnog tkiva).
English: It is recommended that haemoglobin and/or haematocrit levels are measured during treatment with ambrisentan, for example at 1 month, 3 months and periodically thereafter in line with clinical practice.
Croatian: Preporučuje se kontrola vrijednosti hemoglobina i/ili hematokrita za vrijeme liječenja ambrisentanom, npr. nakon 1. i 3. mjeseca, te potom periodički, u skladu s kliničkom praksom.
English: Therefore, caution is recommended in the case of co-administration.
Croatian: Stoga se u slučaju njihove istovremene primjene preporučuje oprez.
English: The testicular changes were not fully recoverable during the off-dose periods evaluated.
Croatian: Promjene u testisu se nisu u potpunosti povukle tijekom perioda praćenja bez primjene lijeka.
English: No evidence for mutagenic or genotoxic effects of ambrisentan were seen in bacteria or in two in vivo rodent studies.
Croatian: Nisu nađeni dokazi mutagenog ili genotoksičnog potencijala ambrisentana na bakterije ili u dva in vivo ispitivanja na glodavcima.
English: The symptoms of your condition can also make you less fit to drive or use machines.
Croatian: Simptomi bolesti mogu također smanjiti sposobnost upravljanja vozilom i rada sa strojevima.
English: The safety of ambrisentan has been evaluated as monotherapy and/or in combination in clinical trials of more than 1,200 patients with PAH (see section 5.1).
Croatian: Sigurnost ambrisentana ocjenjivala se u monoterapiji i/ili kombiniranoj terapiji u kliničkim ispitivanjima provedenima u više od 1200 bolesnika s PAH-om (vidjeti dio 5.1).
English: Ambrisentan has minor or moderate influence on the ability to drive and use machines.
Croatian: Ambrisentan malo ili umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Therefore, at concentrations observed in the plasma (approximately 4% relative to parent ambrisentan), 4-hydroxymethyl ambrisentan is not expected to contribute to pharmacological activity of ambrisentan.
Croatian: Stoga se pri koncentracijama zabilježenim u plazmi (oko 4% izvornog ambrisentana), od 4-hidroksimetil ambrisentana ne očekuje doprinos farmakološkoj aktivnosti ambrisentana.
English: Ambrisentan also undergoes oxidative metabolism mainly by CYP3A4 and to a lesser extent by CYP3A5 and CYP2C19 to form 4-hydroxymethyl ambrisentan (21%) which is further glucuronidated to 4-hydroxymethyl ambrisentan glucuronide (5%).
Croatian: Ambrisentan se također metabolizira oksidativnim metabolizmom uglavnom putem CYP3A4, a manje putem CYP3A5 i CYP2C19 do 4-hidroksimetil ambrisentana (21%), koji se potom metabolizira glukuronidacijom do 4-hidroksimetil ambrisentan glukuronida (5%).
English: The cumulative incidence of serum aminotransferase abnormalities >3xULN in all Phase 2 and 3 studies (including respective open label extensions) was 17 of 483 subjects over a mean exposure duration of 79.5 weeks.
Croatian: Kumulativna incidencija abnormalnosti serumskih aminotransferaza veća od 3 puta iznad gornje granice normale u fazi 2 i 3 ispitivanja (uključujući i otvorene produžetke ispitivanja), bila je 17 od 483 ispitanika, tijekom izloženosti srednjeg trajanja 79,5 tjedana.
English: Ambrisentan Mylan widens the pulmonary arteries, making it easier for the heart to pump blood through them.
Croatian: Ambrisentan Mylan proširuje plućne arterije što srcu olakšava pumpanje krvi kroz njih.
English: Peripheral oedema was reported more frequently with 10 mg ambrisentan in short-term clinical studies (see section 4.8).
Croatian: Periferni edemi prijavljeni su češće pri primjeni ambrisentana u dozi od 10 mg u kratkoročnim kliničkim ispitivanjima (vidjeti dio 4.8).
English: Odds ratio 1.56; 95% CI: 1.05,
Croatian: 95% CI: 1,05;
English: Patients should be monitored for signs of hepatic injury and monthly monitoring of ALT and AST is recommended.
Croatian: Potrebno je pratiti znakove oštećenja jetre kod bolesnika te se preporučuje određivanje AST i ALT jednom mjesečno.
English: Although no clear evidence of a detrimental effect of ambrisentan long-term exposure on sperm count was found in ARIES-E study, chronic administration of ambrisentan was associated with changes in markers of spermatogenesis.
Croatian: Iako u ispitivanju ARIES-E nije pronađen jasan dokaz o štetnom djelovanju ambrisentana na brojnost spermija kod dugoročne primjene, kronična primjena ambrisentana je povezana s promjenama u markerima spermatogeneze.
English: Administration of ambrisentan to female rats from late-pregnancy through lactation caused adverse events on maternal behaviour, reduced pup survival and impairment of the reproductive capability of the offspring (with observation of small testes at necropsy), at exposure 3-fold the AUC at the maximum recommended human dose.
Croatian: Primjena ambrisentana na ženkama štakora tijekom kasne trudnoće i laktacije uzrokovala je štetne događaje u vidu promjena u ponašanju majke, smanjenja preživljenja mladunčadi i poremećaja reproduktivne sposobnosti potomstva (uz nalaz smanjenih testisa na nekropsiji), pri izloženosti kod AUC-a trostruko većeg od onog kod maksimalne preporučene doze u ljudi.
English: Phosphodiesterase inhibitors
Croatian: Inhibitori fosfodiestraze
English: The safety findings observed with long-term ambrisentan exposure in this study were generally consistent with those observed in the 12 week placebo-controlled studies.
Croatian: Rezultati o sigurnosti zamijećeni pri dugotrajnoj izloženosti ambrisentanu u ovom ispitivanju bili su općenito u skladu s rezultatima zamijećenima u 12-tjednim, placebom kontroliranim ispitivanjima.
English: Blood and lymphatic system disorders Anaemia (decreased haemoglobin, decreased haematocrit)
Croatian: Poremećaji krvi i limfnog sustava anemija (snižene vrijednosti hemoglobina, snižene vrijednosti hematokrita)
English: ARIES-2 included 192 patients and compared ambrisentan 2.5 mg and 5 mg with placebo.
Croatian: ARIES-2 je uključilo 192 bolesnika i uspoređivalo je ambrisentan od 2,5 mg i 5 mg s placebom.
English: Effect of ambrisentan on xenobiotic transporters
Croatian: Učinak ambrisentana na prijenosnike ksenobiotika