FrancophonIA/ELRC3.0 huggingface dataset:
English: Ambrisentan Mylan is not recommended for children and adolescents aged under 18 years as the safety and effectiveness is not known in this age group.
Slovenian: Zdravilo Ambrisentan Mylan ni priporočljivo za otroke in mladostnike, mlajše od 18 let, ker njegova varnost in učinkovitost v tej starostni skupini nista znani.
English: • That women of reproductive potential must use effective contraception
Slovenian: • da morajo ženske v rodni dobi uporabljati učinkovito kontracepcijo,
English: See section ‘Description of selected adverse reactions'.
Slovenian: Glejte poglavje „Opis izbranih neželenih učinkov“.
English: Frequency categories do not account for other factors including varying study duration, pre-existing conditions and baseline patient characteristics.
Slovenian: Kategorije pogostnosti ne upoštevajo drugih dejavnikov, vključno z različno dolžino trajanja študij, predhodnim zdravstvenim stanjem in izhodiščnimi značilnostmi bolnika.
English: Doses could also be decreased depending on tolerability.
Slovenian: Odmerke je bilo mogoče tudi zmanjšati, odvisno od prenašanja zdravila.
English: • whether your liver is working properly.
Slovenian: • če je delovanje jeter pravilno.
English: The primary endpoint was the time to first occurrence of a clinical failure event, defined as: - death, or - hospitalisation for worsening PAH, - disease progression; - unsatisfactory long-term clinical response.
Slovenian: Primarni opazovani dogodek je bil čas do prvega pojava dogodka kliničnega neuspeha, opredeljenega kot: - smrt ali - sprejem v bolnišnico zaradi poslabšanja PAH, - napredovanje bolezni, - nezadovoljiv dolgoročen klinični odziv.
English: Ambrisentan is a potent (Ki 0.016 nM) and highly selective ETA antagonist (approximately 4000-fold more selective for ETA as compared to ETB).
Slovenian: Ambrisentan je močan (Ki 0,016 nM) in izredno selektiven antagonist ETA (približno 4.000-krat bolj selektiven za ETA kot za ETB).
English: You may notice a rash or itching and swelling (usually of the face, lips, tongue or throat), which may cause difficulty in breathing or swallowing.
Slovenian: Opazite lahko izpuščaj ali srbenje in otekanje (ponavadi obraza, ustnic, jezika ali žrela), ki lahko povzroči težave z dihanjem ali požiranjem.
English: The majority of patients had WHO functional Class II (38.4%) or Class III (55.0%) symptoms.
Slovenian: Večina bolnikov je imela simptome funkcijskega razreda II (38,4 %) ali razreda III (55,0 %) po SZO.
English: Endothelin plays a significant role in the pathophysiology of PAH.
Slovenian: Endotelin ima pomembno vlogo pri patofiziologiji PAH.
English: A slight (<10%) decrease in the percentage of morphologically normal sperms was noted at 300 mg/kg/day but not at 100 mg/kg/day (>9-fold clinical exposure at 10 mg/day).
Slovenian: Rahlo (< 10 %) zmanjšanje odstotka morfološko normalnih semenčic so opazili pri odmerku 300 mg/kg/dan, ne pa pri 100 mg/kg/dan (> 9-kratna klinična izpostavljenost pri 10 mg/dan).
English: The median double-blind treatment duration for combination therapy was greater than 1.5 years.
Slovenian: Mediano dvojno slepo trajanje zdravljenja s kombinirano terapijo je bilo več kot 1,5 leta.
English: Patients should be monitored for signs of hepatic injury and monthly monitoring of ALT and AST is recommended.
Slovenian: Bolnike je treba nadzirati glede znakov okvare jeter in priporočljivo je mesečno določanje vrednosti ALT in AST.
English: Ambrisentan has minor or moderate influence on the ability to drive and use machines.
Slovenian: Ambrisentan ima majhen ali zmeren vpliv na sposobnost vožnje in upravljanja strojev.
English: It is important to have regular blood tests, to check for anaemia and that your liver is working properly.
Slovenian: Pomembno je, da redno opravljate preiskave krvi za preverjanje, ali se je pojavila anemija in ali vam jetra delujejo normalno.
English: Long term data
Slovenian: Dolgoročni podatki
English: If you're taking other medicines used to treat PAH (e.g. iloprost, epoprostenol, sildenafil) your doctor may need to monitor you.
Slovenian: Če jemljete druga zdravila za zdravljenje PAH (npr. iloprost, epoprostenol, sildenafil), vas bo vaš zdravnik morda moral nadzirati.
English: This lowers the blood pressure and relieves the symptoms.
Slovenian: Na ta način zniža krvni tlak in ublaži simptome bolezni.
English: • pain in your stomach (abdomen)
Slovenian: • bolečine v trebuhu (abdomnu),
English: Combination with tadalafil (AMBITION)
Slovenian: Kombinacija s tadalafilom (AMBITION)
English: Haemodynamic parameters were not assessed in these studies.
Slovenian: V teh študijah niso vrednotili hemodinamskih parametrov.
English: • high temperature (fever)
Slovenian: • zvišano telesno temperaturo (vročino),
English: Other targeted PAH treatments
Slovenian: Druga usmerjena zdravila za PAH
English: This can cause light-headedness.
Slovenian: Povzroči lahko vrtoglavico.
English: The mean age of all patients was 54 years (SD 15; range 18-75 years of age).
Slovenian: Povprečna starost vseh bolnikov je bila 54 let (standardni odklon 15, razpon 18 - 75 let).
English: Talk to your doctor, pharmacist or nurse before taking this medicine if you have:
Slovenian: Posvetujte se z zdravnikom, farmacevtom ali medicinsko sestro, preden vzamete to zdravilo, če imate:
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).
Slovenian: Učinkovitost kombiniranega zdravljenja na primarni opazovani dogodek se je skladala s primerjavo z vsako posamezno monoterapijo in v podskupinah po starosti, etničnem izvoru, geografski regiji in etiologiji (iPAH/hPAH in PAH-CTD).
English: • palpitations (fast or irregular heart-beats)
Slovenian: • palpitacije (hitro ali neredno bitje srca),
English: The occurrence of peripheral oedema was highest within the first month of treatment initiation.
Slovenian: Pojavljanje perifernih edemov je bilo največje v prvem mesecu po uvedbi zdravljenja.
English: It is used to treat pulmonary arterial hypertension (PAH) in adults.
Slovenian: Uporablja se za zdravljenje pljučne arterijske hipertenzije (PAH) pri odraslih.
English: Disease progression
Slovenian: Napredovanje bolezni
English: • feeling tired
Slovenian: • utrujenost.
English: Generics (UK) Limited, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Slovenian: Generics (UK) Limited, Potters Bar, Hertfordshire, EN6 1TL, Velika Britanija
English: Hypotension (low blood pressure)
Slovenian: Hipotenzija (nizek krvni tlak)
English: The treatment effect was driven by a 63% reduction in hospitalisations on combination therapy, was established early and was sustained.
Slovenian: Vodilni vpliv pri terapevtskem učinku je imelo 63-odstotno zmanjšanje sprejemov v bolnišnico s kombiniranim zdravljenjem; pojavilo se je zgodaj in se je ohranilo.
English: • blurry or other changes to vision
Slovenian: • zamegljen vid ali druge spremembe vida,
English: Therefore, caution is recommended in the case of co-administration.
Slovenian: Zato je v primeru sočasne uporabe potrebna previdnost.
English: PAH is high blood pressure in the blood vessels (the pulmonary arteries) that carry blood from the heart to the lungs.
Slovenian: PAH pomeni visok krvni tlak v krvnih žilah (pljučnih arterijah), ki dovajajo kri iz srca v pljuča.
English: Idiopathic Pulmonary Fibrosis
Slovenian: Idiopatska pljučna fibroza
English: → Don't take Ambrisentan Mylan if you are pregnant or planning to become pregnant.
Slovenian: → Ne jemljite zdravila Ambrisentan Mylan, če ste noseči ali nameravate zanositi.
English: • sudden hearing loss.
Slovenian: • nenadna izguba sluha.
English: • worsening shortness of breath shortly after starting Ambrisentan Mylan
Slovenian: • poslabšanje težkega dihanja kmalu po začetku uporabe zdravila Ambrisentan Mylan,
English: Other clinical information
Slovenian: Drugi klinični podatki
English: Your doctor may need to adjust your dose of Ambrisentan Mylan if you start taking cyclosporine A (a medicine used after transplant or to treat psoriasis).
Slovenian: Zdravnik vam lahko prilagodi odmerek zdravila Ambrisentan Mylan, če začnete jemati ciklosporin A (zdravilo, ki se uporablja po presaditvah organov ali za zdravljenje luskavice).
English: Ambrisentan Mylan may also be used in combination with other medicines used to treat PAH.
Slovenian: Zdravilo Ambrisentan Mylan se lahko uporablja tudi v kombinaciji z drugimi zdravili za zdravljenje PAH.
English: Patients enrolled into ARIES-1 and 2 were eligible to enter a long-term open label extension study ARIES-E (n=383).
Slovenian: Bolniki, vključeni v študiji ARIES-1 in 2, so izpolnjevali pogoje za vključitev v dolgoročno odprto podaljšano študijo ARIES E (n = 383).
English: Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.
Slovenian: Učinkovitost je bila dokazana pri idiopatični PAH (IPAH) in pri PAH, povezani z boleznijo vezivnega tkiva.
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.
Slovenian: Pri mladih podganah, ki so ambrisentan dobivale peroralno enkrat na dan od 7. do 26., 36. ali 62. dne po skotitvi, se je pojavilo zmanjšanje mase možganov (−3 % do −8 %), brez morfoloških ali nevrovedenjskih sprememb, po opaženih dihalnih zvokih, apneji in hipoksiji.
English: Plasma elimination half-life in humans ranges from 13.6 to 16.5 hours.
Slovenian: Pri človeku se plazemski razpolovni čas izločanja giblje od 13,6 do 16,5 ur.
English: • The need for regular monitoring of liver function because Ambrisentan Mylan may cause liver injury.
Slovenian: • da je treba redno spremljati delovanje jeter, ker zdravilo Ambrisentan Mylan lahko povzroči okvare jeter.
English: Your doctor may decide to increase your dose to 10 mg, once a day.
Slovenian: Zdravnik lahko odmerek poveča do 10 mg enkrat na dan.
English: Treatment must be initiated by a physician experienced in the treatment of PAH.
Slovenian: Zdravljenje sme uvesti le zdravnik, ki ima izkušnje z zdravljenjem PAH.
English: Hospitalisation for worsening PAH
Slovenian: Sprejem v bolnišnico zaradi poslabšanja PAH
English: Ketoconazole
Slovenian: Ketokonazol
English: Do not use this medicine after the expiry date which is stated on the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli ali pretisnem omotu poleg oznake „EXP“.
English: In both studies, treatment with ambrisentan resulted in a significant improvement in 6MWD for each dose of ambrisentan.
Slovenian: V obeh študijah je zdravljenje z ambrisentanom pomembno izboljšalo rezultat 6MWD pri vseh odmerkih ambrisentana.
English: Difference and Confidence Interval p-value
Slovenian: Razlika in interval zaupanja
English: Date of first authorisation: Date of latest renewal:
Slovenian: Datum zadnjega podaljšanja:
English: If you take cyclosporine A, do not take more than one 5 mg tablet of Ambrisentan Mylan once a day.
Slovenian: Če jemljete ciklosporin A, ne smete vzeti več kot ene 5 mg tablete zdravila Ambrisentan Mylan enkrat na dan.
English: This decrease in peak concentration is not clinically significant, and therefore ambrisentan can be taken with or without food.
Slovenian: To zmanjšanje največje koncentracije ni klinično pomembno, zato lahko bolniki ambrisentan jemljejo skupaj s hrano ali brez nje.
English: Most of these decreases were detected during the first 4 weeks of treatment and haemoglobin generally stabilised thereafter.
Slovenian: Znižanja so se večinoma pojavila med prvimi 4 tedni zdravljenja, nato pa se je koncentracija hemoglobina običajno stabilizirala.
English: Ambrisentan is primarily bound to albumin (96.5%) and to a lesser extent to alpha1-acid glycoprotein.
Slovenian: Ambrisentan se v glavnem veže na albumin (96,5 %), v manjšem obsegu pa tudi na alfa1-kisli glikoprotein.
English: The measure included: death, lung transplantation, hospitalisation for PAH, atrial septostomy, addition of other PAH therapeutic agents and early escape criteria.
Slovenian: V vrednotenje so bili vključeni: smrt, presaditev pljuč, sprejem na zdravljenje v bolnišnico zaradi PAH, septostomija preddvornega pretina, uvedba drugih zdravil za zdravljenje PAH in zgodnji izključitveni kriteriji.
English: These effects occurred at exposures approximately 1.8 to 7 times human paediatric exposures at 10 mg (age 9 to 15 years), based on AUC.
Slovenian: Ti učinki so se pojavili pri izpostavljenostih, ki so bile glede na AUC približno 1,8- do 7-krat tolikšne, kot so pri človeku izpostavljenosti pediatričnih bolnikov (v starosti od 9 do 15 let) ob odmerku 10 mg.
English: McDermott Laboratories t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Slovenian: McDermott Laboratories t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Irska
English: Two randomised, double-blind, multi-centre, placebo controlled, Phase 3 pivotal studies were conducted (ARIES-1 and 2).
Slovenian: Izvedeni sta bili dve randomizirani, dvojno slepi, multicentrični s placebom nadzorovani ključni študiji 3. faze (ARIES-1 in 2).
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.
Slovenian: Gre za posledico tega, da srce ne prečrpa dovolj krvi; to povzroča kratko sapo, skrajno utrujenost in otekanje gležnjev in nog.
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).
Slovenian: Varnost ambrisentana so v kliničnih preskušanjih vrednotili v monoterapiji in/ali v kombinaciji pri več kot 1.200 bolnikih s PAH (glejte poglavje 5.1).
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.
Slovenian: Izhodiščno 96 % bolnikov predhodno še ni bilo deležnih nobenega specifičnega zdravljenja PAH in mediani čas od postavitve diagnoze do vstopa v študijo je bil 22 dni.
English: However, no specific drug-drug interactions studies have been conducted with these active substances.
Slovenian: Vendar pa s temi učinkovinami niso izvedli specifičnih študij medsebojnega delovanja zdravil.
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.
Slovenian: Izsledki o varnosti, zabeleženi med dolgotrajno izpostavljenostjo ambrisentanu v tej študiji, so se na splošno ujemali s tistimi v 12-tedenskih študijah, kontroliranih s placebom.
English: • Patient Reminder Card
Slovenian: • Opozorilna kartica za bolnika
English: Idiopathic or heritable PAH was the most common aetiology in the study population (56%), followed by PAH due to connective tissue disorders (37%), PAH associated with medicines and toxins (3%), corrected simple congenital heart disease (2%), and HIV (2%).
Slovenian: Najpogostejši vzrok je bila v študijski populaciji idiopatska ali dedna PAH (56 %), sledili so PAH zaradi bolezni vezivnega tkiva (37 %), PAH, povezana z zdravili in toksini (3 %), korigirane enostavne prirojene srčne napake (2 %) in HIV (2 %).
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).
Slovenian: Poleg tega pa ambrisentan pri bolnikih na splošno tudi ni vplival na tedenski odmerek antikoagulanta varfarinskega tipa, protrombinski čas (PTProthrombin Time) in mednarodno normalizirano razmerje (INR - International Normalized Ratio).
English: In healthy volunteers, single doses of 50 and 100 mg (5 to 10 times the maximum recommended dose) were associated with headache, flushing, dizziness, nausea and nasal congestion.
Slovenian: Pri zdravih prostovoljcih so bili enkratni odmerki po 50 in 100 mg (5- do 10-krat večji odmerek od največjega priporočenega odmerka) povezani z glavobolom, zardevanjem, omotico, navzeo in nosno kongestijo.
English: If you forget a dose of Ambrisentan Mylan, just take the tablet as soon as you remember, then carry on as before.
Slovenian: Če ste pozabili vzeti odmerek zdravila Ambrisentan Mylan, vzemite tableto takoj, ko se spomnite, nato pa nadaljujte z jemanjem zdravila ob običajnem času.
English: Ambrisentan has not been studied in a sufficient number of patients to establish the benefit/risk balance in WHO functional class I PAH.
Slovenian: Ambrisentan ni bil raziskan pri zadostnem številu bolnikov, da bi lahko ugotovili razmerje med koristjo in tveganjem pri PAH funkcijskega razreda I po SZO.
English: Pulmonary veno-occlusive disease
Slovenian: Pljučna venookluzivna bolezen
English: The excretion of ambrisentan in milk has not been studied in animals.
Slovenian: Izločanja ambrisentana v mleko pri živalih niso raziskovali.
English: What Ambrisentan Mylan is and what it is used for What you need to know before you take Ambrisentan Mylan How to take Ambrisentan Mylan Possible side effects
Slovenian: Kaj je zdravilo Ambrisentan Mylan in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Ambrisentan Mylan Kako jemati zdravilo Ambrisentan Mylan Možni neželeni učinki
English: Animal studies have shown that ambrisentan is teratogenic.
Slovenian: Študije na živalih kažejo, da je ambrisentan teratogen.
English: Patients enrolled had IPAH or PAH associated with connective tissue disease (PAH-CTD).
Slovenian: Vključeni bolniki so imeli IPAH ali PAH, povezano z boleznijo vezivnega tkiva (PAH-CTD).
English: Before you start taking Ambrisentan Mylan, and at regular intervals while you're taking it, your doctor will take blood tests to check:
Slovenian: Pred začetkom zdravljenja z zdravilom Ambrisentan Mylan in v rednih časovnih presledkih med zdravljenjem bo zdravnik opravljal krvne preiskave, s katerimi bo preverjal:
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.
Slovenian: Med zdravljenjem z ambrisentanom, ki je v povprečju trajalo 53 tednov, pri nobenem od vključenih bolnikov niso potrdili vrednosti serumske ALT > 3 x ZMN, ki bi zahtevala trajno prekinitev zdravljenja.
English: This is a blood disorder which can cause tiredness, weakness, shortness of breath, and generally feeling unwell.
Slovenian: To je krvna motnja, ki lahko povzroči utrujenost, šibkost, kratko sapo in splošno slabo počutje.
English: The in-vitro plasma protein binding of ambrisentan was, on average, 98.8% and independent of concentration over the range of 0.2 - 20 microgram/ml.
Slovenian: Vezava ambrisentana na plazemske proteine je bila in vitro v povprečju 98,8-odstotna in v razponu od 0,2 do 20 mikrogramov/ml neodvisna od koncentracije.
English: Nervous system disorders Headache (including sinus headache, migraine)
Slovenian: Bolezni živčevja glavobol (vključno s sinusnim glavobolom, migreno)
English: An improvement in haemodynamic parameters was observed in patients with PAH after 12 weeks (n=29) in a Phase 2 study (AMB220).
Slovenian: Pri bolnikih s PAH je bilo po 12 tednih (n = 29) v študiji 2. faze (AMB220) opaženo izboljšanje hemodinamskih parametrov.
English: Peripheral oedema was reported more frequently with 10 mg ambrisentan in short-term clinical studies (see section 4.8).
Slovenian: O perifernem edemu so pogosteje poročali pri uporabi 10 mg odmerka ambrisentana v kratkotrajnih kliničnih študijah (glejte poglavje 4.8)
English: • anaemia (a reduced number of red blood cells)
Slovenian: • anemijo (zmanjšano število rdečih krvnih celic),
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).
Slovenian: V študiji AMBITION so bolniki prvih 8 tednov prejemali 5 mg ambrisentana na dan, preden so jim odmerek povečali na 10 mg, odvisno od prenašanja (glejte poglavje 5.1).
English: What Ambrisentan Mylan is and what it is used for
Slovenian: Kaj je zdravilo Ambrisentan Mylan in za kaj ga uporabljamo
English: • That pregnant women must not take Ambrisentan Mylan
Slovenian: • da nosečnice ne smejo jemati zdravila Ambrisentan Mylan,
English: If you're taking rifampicin (an antibiotic used to treat serious infections) your doctor will monitor you when you first start taking Ambrisentan Mylan.
Slovenian: Če jemljete rifampicin (antibiotik za zdravljenje resnih okužb), vas bo zdravnik nadziral, ko boste začeli jemati zdravilo Ambrisentan Mylan.
English: • swelling in the hands, ankles or feet caused by fluid (peripheral oedema)
Slovenian: • otekle dlani, gležnje ali stopala zaradi kopičenja tekočine (periferni edem),
English: → Tell your doctor or pharmacist if you are taking any of these medicines.
Slovenian: → Svojemu zdravniku ali farmacevtu morate povedati, če jemljete katero od teh zdravil.
English: The binding affinity of 4-hydroxymethyl ambrisentan for the human endothelin receptor is 65-fold less than ambrisentan.
Slovenian: Vezavna afiniteta 4-hidroksimetil ambrisentana za humane endotelinske receptorje je 65-krat manjša od vezavne afinitete ambrisentana.
English: Limited data suggest that the abrupt discontinuation of ambrisentan is not associated with rebound worsening of PAH.
Slovenian: Maloštevilni podatki kažejo, da nenadna prekinitev zdravljenja z ambrisentanom ni povezana s povratnim pojavom poslabšanja PAH.
English: Swelling (oedema), especially of the ankles and feet
Slovenian: Otekanje (edemi), zlasti gležnjev in stopal
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.
Slovenian: Glavna primarna opazovana dogodka te študije sta bila incidenca in izrazitost neželenih učinkov, povezanih z dolgotrajno izpostavljenostjo ambrisentanu, vključno s serumskimi LFT.
English: Adverse reaction frequency categories assigned based on clinical trial experience may not reflect the frequency of adverse events occurring during normal clinical practice.
Slovenian: Možno je, da kategorije pogostnosti neželenih učinkov, določene na osnovi izkušenj iz kliničnih preskušanj, ne odražajo pogostnosti neželenih učinkov med običajno klinično prakso.
English: Secondary Endpoints (change from baseline to week 24)
Slovenian: Sekundarni opazovani dogodki (sprememba od izhodišča do 24. tedna)
English: It is recommended that the tablet should not be split, crushed or chewed.
Slovenian: Priporočljivo je, da bolniki tablet ne lomijo, ne drobijo in ne žvečijo.
English: Based on this pharmacokinetic study, ambrisentan would not be expected to significantly affect exposure to oestrogen- or progestogenbased contraceptives.
Slovenian: Na podlagi te farmakokinetične študije ni pričakovati, da bi ambrisentan pomembno vplival na izpostavljenost estrogenskim oz. progestogenskim kontraceptivom.
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).
Slovenian: V obeh študijah so ambrisentan uvedli dodatno k podpornemu/osnovnemu zdravljenju, ki je lahko vključevalo kombinacijo digoksina, antikoagulantov, diuretikov, kisika in vazodilatatorjev (zaviralci kalcijevih kanalčkov, zaviralci ACE).
English: There is no experience in PAH patients of ambrisentan at daily doses greater than 10 mg.
Slovenian: Pri bolnikih s PAH ni izkušenj z ambrisentanom v dnevnih odmerkih, večjih od 10 mg.