FrancophonIA/ELRC3.0 huggingface dataset:
English: → Don't drive or use machines if you're feeling unwell.
Croatian: → Nemojte voziti ili upravljati strojevima ako se ne osjećate dobro.
English: No additional safety concerns were identified in these patients.
Croatian: Nisu uočeni dodatni sigurnosni problemi u tih bolesnika.
English: Conditions you and your doctor need to look out for:
Croatian: Stanja na koja Vi i Vaš liječnik morate pripaziti:
English: Talk to your doctor about this.
Croatian: Razgovarajte sa svojim liječnikom o tome.
English: Sometimes this requires a blood transfusion.
Croatian: Ponekad zahtijeva transfuziju krvi.
English: More than 90% of patients achieved this.
Croatian: To je provedeno u više od 90% bolesnika.
English: 6MWD (metres, median change)
Croatian: 6MWD (metri, medijan promjene)
English: Doses could also be decreased depending on tolerability.
Croatian: Doze su se mogle i smanjiti ovisno o podnošljivosti.
English: No specific antidote is available.
Croatian: Nema specifičnog antidota.
English: Ask your pharmacist how to throw away medicines you no longer use.
Croatian: Pitajte svog ljekarnika kako baciti lijekove koji više ne koristite.
English: • whether your liver is working properly.
Croatian: • radi li Vaša jetra ispravno.
English: • The need for monthly pregnancy tests
Croatian: • informaciju o potrebi provođenja mjesečnih testova na trudnoću
English: PVC/PVdC blisters
Croatian: PVC/PVdC blisteri
English: Unsatisfactory long-term clinical response
Croatian: Nezadovoljavajući dugoročan klinički odgovor
English: Long term data
Croatian: Dugoročni podaci
English: The advice of a hepatologist is recommended.
Croatian: Preporučuje se konzultirati hepatologa.
English: % subjects achieving a satisfactory clinical response at week 24
Croatian: % ispitanika koji su ostvarili zadovoljavajući klinički odgovor u 24. tjednu
English: • That women of reproductive potential must use effective contraception
Croatian: • da žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju
English: Cyclosporine A
Croatian: Ciklosporin A
English: Ambrisentan (AMBITION and ARIES-E)
Croatian: Ambrisentan (AMBITION i ARIES-E)
English: • whether you have anaemia
Croatian: • imate li anemiju
English: Your doctor will decide whether Ambrisentan Mylan is suitable for you.
Croatian: Vaš liječnik će odlučiti je li Ambrisentan Mylan prikladan za Vas.
English: Patient reminder card should include the following messages
Croatian: Kartica s podsjetnikom za bolesnike treba sadržavati sljedeće poruke:
English: It is recommended that the tablet is swallowed whole and it can be taken with or without food.
Croatian: Preporučuje se tabletu progutati cijelu, a može se uzeti sa ili bez hrane.
English: There is no experience in humans.
Croatian: Nema iskustva s primjenom u ljudi.
English: Difference and Confidence Interval p-value
Croatian: Razlika i interval pouzdanosti p-vrijednost
English: In the case of pronounced hypotension, active cardiovascular support may be required.
Croatian: U slučaju izražene hipotenzije može se ukazati potreba za aktivnom kardiovaskularnom potporom.
English: Date of first authorisation: Date of latest renewal:
Croatian: Datum prvog odobrenja: Datum posljednje obnove odobrenja:
English: Other clinical information
Croatian: Ostale kliničke informacije
English: You will need regular blood tests
Croatian: Morat ćete redovito provoditi krvne pretrage
English: The combined mean exposure was approximately 145 ± 80 weeks, and the maximum exposure was approximately 295 weeks.
Croatian: Kombinirana srednja vrijednost izloženosti bila je oko 145 ± 80 tjedana, a maksimalna izloženost bila je oko 295 tjedana.
English: Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data).
Croatian: Učestalost je definirana kao: vrlo često (≥ 1/10), često (≥ 1/100 do < 1/10), manje često (≥ 1/1000 do < 1/100), rijetko (≥ 1/10 000 do < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Hypotension (low blood pressure)
Croatian: Hipotenzija (nizak krvni tlak)
English: If you have been told by your doctor that you have an intolerance to some sugars:
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere: →
English: The treatment effect was driven by a 63% reduction in hospitalisations on combination therapy, was established early and was sustained.
Croatian: Učinak liječenja temeljio se na smanjenju hospitalizacija za 63% uz kombiniranu terapiju, uspostavljen je rano i bio je održan.
English: • pain in your stomach (abdomen)
Croatian: • bol u trbuhu (abdomenu)
English: Your doctor may decide to increase your dose to 10 mg, once a day.
Croatian: Liječnik može odlučiti povećati Vam dozu na 10 mg jednom dnevno.
English: The clinical relevance of this finding to the paediatric population is not fully understood.
Croatian: Klinički značaj ovog nalaza za pedijatrijsku populaciju nije u potpunosti poznat.
English: The safety and efficacy of ambrisentan in children and adolescents aged below 18 years has not been established.
Croatian: Sigurnost i djelotvornost ambrisentana u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
English: Hospitalisation for worsening PAH
Croatian: Hospitalizacija zbog pogoršanja PAH-a
English: P-value, Log-rank test
Croatian: P-vrijednost, log-rang test
English: It is used to treat pulmonary arterial hypertension (PAH) in adults.
Croatian: Koristi se za liječenje plućne arterijske hipertenzije (PAH) u odraslih.
English: It belongs to a group of medicines called other antihypertensives (used to treat high blood pressure).
Croatian: On pripada skupini lijekova koji se nazivaju „ostali antihipertenzivi“ (koriste se za liječenje visokog krvnog tlaka).
English: A pre-specified combined analysis of the Phase 3 studies (ARIES-C) was conducted.
Croatian: Provedena je i predviđena kombinirana analiza faze 3 (ARIES-C).
English: → Don't take Ambrisentan Mylan if you are pregnant or planning to become pregnant.
Croatian: Nemojte uzimati Ambrisentan Mylan ako ste trudni ili planirate trudnoću.
English: Pharmacotherapeutic group: Anti-hypertensives, other anti-hypertensives, ATC code: C02KX02
Croatian: Farmakoterapijska skupina: antihipertenzivi, ostali antihipertenzivi: ATK oznaka: C02KX02
English: This lowers the blood pressure and relieves the symptoms.
Croatian: To dovodi do snižavanja krvnog tlaka i olakšavanja simptoma.
English: Plasma elimination half-life in humans ranges from 13.6 to 16.5 hours.
Croatian: Poluvrijeme eliminacije u plazmi u ljudi iznosi od 13,6 do 16,5 sati.
English: → Ask your doctor or pharmacist for advice if you take more tablets than prescribed.
Croatian: → Upitajte svog liječnika ili ljekarnika za savjet ako uzmete više tableta nego što je propisano.
English: In combination with tadalafil (another PAH medicine) in addition to the above:
Croatian: U kombinaciji s tadalafilom (još jednim lijekom za PAH) dodatno uz gore navedene nuspojave:
English: Make sure that you have also read the information in section 2 under ‘You will need regular blood tests' and ‘Signs that your liver may not be working properly'.
Croatian: Svakako pročitajte informacije u dijelu 2 pod „Morat ćete redovito provoditi krvne pretrage“ i „Znakovi mogućeg nepravilnog rada jetre“.
English: • blurry or other changes to vision
Croatian: • zamagljen vid ili druge promjene vida
English: Treatment must be initiated by a physician experienced in the treatment of PAH.
Croatian: Liječenje mora započeti liječnik s iskustvom u liječenju PAH-a.
English: Combination with tadalafil (AMBITION)
Croatian: Kombinacija s tadalafilom (AMBITION)
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).
Croatian: Ambrisentan je potentan (Ki 0,016 nM) i visoko selektivan ETA antagonist (približno 4000 puta selektivniji za ETA u usporedbi s 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.
Croatian: Možda ćete primijetiti osip ili svrbež i oticanje (obično lica, usana, jezika ili grla), koje može uzrokovati otežano disanje ili gutanje.
English: However, no specific drug-drug interactions studies have been conducted with these active substances.
Croatian: Međutim, nisu provedena specifična ispitivanja interakcija s lijekovima koji sadrže te djelatne tvari.
English: →Don't stop taking Ambrisentan Mylan unless you have agreed this with your doctor.
Croatian: Nemojte prestati uzimati Ambrisentan Mylan osim ako se tako niste dogovorili sa svojim liječnikom.
English: Patients enrolled into ARIES-1 and 2 were eligible to enter a long-term open label extension study ARIES-E (n=383).
Croatian: Bolesnici uključeni u ARIES-1 i 2 su mogli biti uključeni u dugoročno otvoreno, produženo ispitivanje ARIES-E (n=383).
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.
Croatian: Primarna mjera ishoda bilo je vrijeme do prvog nastupa događaja kliničkog neuspjeha, koji se definirao kao: - smrt ili - hospitalizacija zbog pogoršanja PAH-a - progresija bolesti - nezadovoljavajući dugoročan klinički odgovor
English: • ringing in the ears (tinnitus) only when taking the combination treatment.
Croatian: • zvonjava u ušima (tinitus), samo kod kombinirane terapije
English: The effect on male human fertility is not known but a deterioration of spermatogenesis cannot be excluded.
Croatian: Utjecaj na plodnost muškaraca nije poznat, no ne može se isključiti smanjenje spermatogeneze.
English: The median double-blind treatment duration for combination therapy was greater than 1.5 years.
Croatian: Medijan trajanja dvostruko slijepog liječenja kombiniranom terapijom bio je dulji od 1,5 godina.
English: • high temperature (fever)
Croatian: • povišenu tjelesnu temperaturu (vrućicu)
English: • worsening shortness of breath shortly after starting Ambrisentan Mylan
Croatian: • pogoršanje nedostatka zraka ubrzo nakon početka uzimanja lijeka Ambrisentan Mylan
English: This is an event rate of 2.3 events per 100 patient years of exposure for ambrisentan.
Croatian: To je stopa događaja od 2,3 događaja na 100 bolesnik-godina izloženosti za ambrisentan.
English: • dark-coloured urine
Croatian: • tamnu boju urina
English: Endothelin plays a significant role in the pathophysiology of PAH.
Croatian: Endotelin igra značajnu ulogu u patofiziologiji PAH-a.
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).
Croatian: Malo (< 10%) smanjenje postotka morfološki normalnih spermija zabilježeno je pri dozi 300 mg/kg/dan ali ne pri dozi 100 mg/kg/dan (> 9 puta kliničke izloženosti pri 10 mg/dan).
English: • The need for regular monitoring of liver function because Ambrisentan Mylan may cause liver injury.
Croatian: • informaciju o potrebi redovitog praćenja funkcije jetre jer lijek Ambrisentan Mylan može uzrokovati oštećenje jetre.
English: If you are a man taking Ambrisentan Mylan, it is possible that this medicine may lower your sperm count.
Croatian: Ako ste muškarac koji uzima Ambrisentan Mylan, moguće je da će ovaj lijek utjecati na smanjenje broja spermija.
English: Swelling (oedema), especially of the ankles and feet
Croatian: Oticanje (edem), osobito gležnjeva i stopala
English: Very common Very common
Croatian: vrlo često vrlo često
English: Read the information under ‘Breast-feeding' - if you have liver disease.
Croatian: Pročitajte informacije pod naslovom „Dojenje“ - ako bolujete od bolesti jetre.
English: If you forget a dose of Ambrisentan Mylan, just take the tablet as soon as you remember, then carry on as before.
Croatian: Ako zaboravite uzeti tabletu lijeka Ambrisentan Mylan uzmite ju čim se sjetite, a zatim nastavite liječenje kao i prije.
English: PAH is high blood pressure in the blood vessels (the pulmonary arteries) that carry blood from the heart to the lungs.
Croatian: PAH je povišeni krvni tlak u krvnim žilama (plućnim arterijama) koje prenose krv od srca prema plućima.
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
Croatian: Što je Ambrisentan Mylan i za što se koristi Što morate znati prije nego počnete uzimati Ambrisentan Mylan Kako uzimati Ambrisentan Mylan Moguće nuspojave
English: Disease progression
Croatian: Progresija bolesti
English: What Ambrisentan Mylan is and what it is used for
Croatian: Što je Ambrisentan Mylan i za što se koristi
English: It is important to have regular blood tests, to check for anaemia and that your liver is working properly.
Croatian: Iznimno je važno redovito raditi krvne pretrage, kako bi provjerili imate li anemiju te radi li Vaša jetra ispravno.
English: • palpitations (fast or irregular heart-beats)
Croatian: • osjećaj lupanja srca (brzi ili nepravilni otkucaji srca)
English: Idiopathic Pulmonary Fibrosis
Croatian: Idiopatska plućna fibroza
English: If you're taking other medicines used to treat PAH (e.g. iloprost, epoprostenol, sildenafil) your doctor may need to monitor you.
Croatian: Ako uzimate druge lijekove za liječenje PAH-a (npr. iloprost, epoprostenol, sildenafil), liječnik će Vas možda morati nadzirati.
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.
Croatian: Ne preporučuje se primjena lijeka Ambrisentan Mylan u djece i adolescenata mlađih od 18 godina jer sigurnost i djelotvornost lijeka u toj dobnoj skupini nisu poznate.
English: Signs that your liver may not be working properly include:
Croatian: Znakovi mogućeg nepravilnog rada jetre uključuju:
English: → Tell your doctor straight away if you get these effects or if they happen suddenly after taking Ambrisentan Mylan.
Croatian: Odmah recite liječniku ako osjetite takve simptome ili ako se jave iznenada nakon uzimanja lijeka Ambrisentan Mylan.
English: There is limited experience with ambrisentan in individuals with severe renal impairment (creatinine clearance <30 ml/min); therapy should be initiated cautiously in this subgroup and particular care taken if the dose is increased to 10 mg ambrisentan.
Croatian: Postoji ograničeno iskustvo primjene ambrisentana u pojedinaca s teškim oštećenjem bubrega (klirens kreatinina < 30 ml/min); terapiju treba započeti oprezno u ovoj podskupini, a naročito treba paziti ako se doza ambrisentana poveća na 10 mg.
English: • a runny or blocked nose, congestion or pain in the sinuses
Croatian: • curenje nosa ili začepljen nos, začepljenje ili bol u sinusima
English: A decrease in plasma inhibin-B concentration and an increase in plasma FSH concentration were observed.
Croatian: Primijećeno je smanjenje koncentracije inhibina B u plazmi i povećanje koncentracije FSH u plazmi.
English: However no testicular changes were observed in dog studies of up to 39 weeks duration at an exposure 35-fold that seen in humans based on AUC.
Croatian: Međutim, testikularne promjene nisu nađene u ispitivanjima na psima u trajanju do 39 tjedana s izloženošću 35 puta većom od one u ljudi temeljene na AUC.
English: → If you become pregnant or think that you may be pregnant while you're taking Ambrisentan Mylan, see your doctor immediately.
Croatian: → Ako zatrudnite ili mislite da ste zatrudnjeli tijekom uzimanja lijeka Ambrisentan Mylan, odmah posjetite svog liječnika.
English: The majority of patients had WHO functional Class II (38.4%) or Class III (55.0%) symptoms.
Croatian: Većina bolesnika je imala simptome funkcionalnog razreda II (38,4%) ili III (55,0%) prema SZO-u.
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%).
Croatian: Idiopatski ili nasljedni PAH bio je najčešća etiologija u ispitivanoj populaciji (56%), a nakon njega su slijedili PAH povezan s bolešću vezivnog tkiva (37%), PAH povezan s lijekovima i toksinima (3%), korigirana jednostavna prirođena srčana bolest (2%) i HIV (2%).
English: Ambrisentan is primarily bound to albumin (96.5%) and to a lesser extent to alpha1-acid glycoprotein.
Croatian: Ambrisentan se prvenstveno veže na albumin (96,5%), a u manjoj mjeri na alfa1-kiseli glikoprotein.
English: Ninety events (27%) of IPF progression (including respiratory hospitalisations) or death were observed in the ambrisentan group compared to 28 events (17%) in the placebo group.
Croatian: Devedeset događaja (27%) progresije IPF-a (uključujući hospitalizaciju zbog respiratornih poteškoća) ili smrti je zapaženo u skupini bolesnika na ambrisentanu u odnosu na 28 događaja (17%) u placebo skupini.
English: Ambrisentan Mylan may cause side effects, such as low blood pressure, dizziness, tiredness (see section 4), that may affect your ability to drive or use machines.
Croatian: Ambrisentan Mylan može uzrokovati nuspojave, poput niskog krvnog tlaka, omaglice, umora (pogledajte dio 4.), koje mogu utjecati na Vašu sposobnost vožnje ili upravljanja strojevima.
English: Generics (UK) Limited, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Croatian: Proizvođač Generics (UK) Limited, Potters Bar, Hertfordshire, EN6 1TL, Ujedinjeno Kraljevstvo
English: Do not use this medicine after the expiry date which is stated on the carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza oznake „EXP”.
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.
Croatian: U zdravih dobrovoljaca, primjena pojedinačne doze od 50 i 100 mg (5 i 10 puta više od maksimalne preporučene doze) bila je povezana s glavoboljom, navalama crvenila, omaglicom, mučninom i nazalnom kongestijom.
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.
Croatian: U in vitro testovima vezanje ambrisentana na proteine plazme prosječno je iznosilo 98,8% i bilo je neovisno o koncentracijama u rasponu od 0,220 mikrograma/ml.
English: An improvement in haemodynamic parameters was observed in patients with PAH after 12 weeks (n=29) in a Phase 2 study (AMB220).
Croatian: Zamijećeno je poboljšanje hemodinamskih pokazatelja u bolesnika s PAH-om nakon 12 tjedana (n=29) u fazi 2 ispitivanja (AMB220).
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.
Croatian: Ako uzimate rifampicin (antibiotik koji se koristi za liječenje ozbiljnih infekcija), liječnik će Vas nadzirati kada započnete uzimati Ambrisentan Mylan.
English: Ambrisentan is absorbed rapidly in humans.
Croatian: U ljudi se ambrisentan brzo apsorbira.
English: Talk to your doctor, pharmacist or nurse before taking this medicine if you have:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete ovaj lijek:
English: With longer observation in uncontrolled studies (mean observation of 79 weeks), the safety profile was similar to that observed in the short- term studies.
Croatian: Sigurnosni profil pri dugotrajnijem praćenju u nekontroliranim ispitivanjima (prosjek praćenja 79 tjedana) bio je sličan onom opaženom u kratkotrajnim ispitivanjima.
English: Ambrisentan Mylan may also be used in combination with other medicines used to treat PAH.
Croatian: Ambrisentan Mylan se može primjenjivati i u kombinaciji s drugim lijekovima za liječenje PAH-a.
English: Mylan Hungary Kft, Mylan utca 1, 2900 Komárom, Hungary
Croatian: Mylan Hungary Kft, Mylan utca 1, 2900 Komárom, Mađarska
English: Before you start taking Ambrisentan Mylan, and at regular intervals while you're taking it, your doctor will take blood tests to check:
Croatian: Prije nego počnete uzimati Ambrisentan Mylan, kao i redovito tijekom liječenja, liječnik će napraviti krvne pretrage kako bi se ustanovilo:
English: Ketoconazole
Croatian: Ketokonazol
English: McDermott Laboratories t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Croatian: McDermott Laboratories t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Irska
English: How to store Ambrisentan Mylan Contents of the pack and other information
Croatian: Kako čuvati Ambrisentan Mylan Sadržaj pakiranja i druge informacije
English: Animal studies have shown that ambrisentan is teratogenic.
Croatian: Ispitivanja na životinjama su pokazala da je ambrisentan teratogen.
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.
Croatian: Ti su se učinci pojavili pri izloženosti približno 1,8 do 7 puta većoj od pedijatrijske izloženosti u ljudi (dob od 9 do 15 godina) pri dozi od 10 mg, temeljno na AUC.
English: Two randomised, double-blind, multi-centre, placebo controlled, Phase 3 pivotal studies were conducted (ARIES-1 and 2).
Croatian: Provedena su dva randomizirana, dvostruko slijepa, multicentrična, placebom kontrolirana ključna ispitivanja faze 3 (ARIES-1 i 2).
English: Women of child-bearing potential who are not using reliable contraception (see sections 4.4 and 4.6).
Croatian: U žena reproduktivne dobi, koje ne koriste pouzdane metode kontracepcije (vidjeti dijelove 4.4 i 4.6).
English: Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.
Croatian: Djelotvornost je pokazana u idiopatskom PAH-u (IPAH) i u PAH-u povezanom s bolešću vezivnog tkiva.
English: If you take cyclosporine A, do not take more than one 5 mg tablet of Ambrisentan Mylan once a day.
Croatian: Ako već uzimate ciklosporin A, ne uzimajte više od jedne tablete lijeka Ambrisentan Mylan od 5 mg jednom dnevno.
English: Secondary Endpoints (change from baseline to week 24)
Croatian: Sekundarne mjere ishoda (promjena od početka ispitivanja do 24. tjedna)
English: This prevents endothelin-mediated activation of second messenger systems that result in vasoconstriction and smooth muscle cell proliferation.
Croatian: To sprječava endotelinom posredovanu aktivaciju sustava drugog glasnika, koja bi rezultirala vazokonstrikcijom i proliferacijom glatkih mišićnih stanica.
English: The magnitude of the decrease in oral clearance is modest (20-40%) in patients with moderate renal impairment and therefore is unlikely to be of any clinical relevance.
Croatian: Veličina smanjenja oralnog klirensa je umjerena (20 - 40%) u bolesnika s umjerenim bubrežnim oštećenjem, pa prema tome vjerojatno nije od kliničkog značaja.
English: Any unused medicinal product or waste material should be disposed of in accordance with the local requirements.
Croatian: Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
English: Ambrisentan (ARIES-C and post marketing)
Croatian: Ambrisentan (ARIES-C i nakon stavljanja lijeka u promet)
English: Ambrisentan Mylan may harm unborn babies conceived before, during or soon after treatment.
Croatian: Ambrisentan Mylan može štetno utjecati na nerođenu djecu začetu prije, tijekom ili ubrzo nakon terapije.
English: Component as First Clinical Failure Event (Adjudicated) Death (all-cause) 9 (4%)
Croatian: Sastavnica kompozitne mjere ishoda kao prvi događaj kliničkog neuspjeha (ocijenjen događaj) Smrt (bilo koji uzrok) 9 (4%)