FrancophonIA/ELRC3.0 huggingface dataset:
English: Opsumit may harm unborn babies conceived before, during or soon after treatment.
Croatian: Opsumit može naškoditi nerođenoj djeci začetoj prije, tijekom ili neposredno nakon liječenja.
English: Exposure to the active metabolite of macitentan was reduced by 26%.
Croatian: Izloženost aktivnom metabolitu macitentanu smanjeno je za 26%.
English: The increase in 6MWD achieved with macitentan was maintained for the duration of the study.
Croatian: Porast u 6MWD postignut s macitentanom održan je tijekom trajanja ispitivanja.
English: You can take Opsumit with or without food.
Croatian: Opsumit možete uzeti s hranom ili bez nje.
English: Therefore, monitoring of blood pressure and haemoglobin should be considered.
Croatian: Stoga treba uzeti u obzir praćenje krvnog tlaka i hemoglobina.
English: The treatment effect was established early and was sustained.
Croatian: Učinak liječenja utvrđen je ranije te je održan.
English: Talk to your doctor or pharmacist before taking Opsumit.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Opsumit.
English: PAH is high blood pressure in the blood vessels that carry blood from the heart to the lungs (the pulmonary arteries).
Croatian: PAH je visoki krvni tlak u krvnim žilama koje prenose krv iz srca u pluća (plućne arterije).
English: Like other medicines of this class, Opsumit can induce anaemia (a reduced number of red blood cells) and can have effects on the liver.
Croatian: Poput svih drugih lijekova ove skupine, Opsumit može uzrokovati anemiju (smanjen broj crvenih krvnih stanica) i može imati utjecaj na jetru.
English: Patients should be monitored for signs of hepatic injury and monthly monitoring of ALT and AST is recommended.
Croatian: Bolesnike treba pratiti na pojave znakova oštećenja jetre, a preporučuje se i mjesečno praćenje LT i AST.
English: Treatment of juvenile rats from postnatal Day 4 to Day 114 caused reduced body weight gain leading to secondary effects on development (slight delay of descensus testis, reversible reduction of long-bone length, prolonged estrous cycle).
Croatian: Liječenje mladih štakora od postnatalnog dana 4 do dana 114 uzrokovalo je smanjenu tjelesnu težinu koja je imala sekundarne učinke na razvoj (blaga odgoda spuštanja testisa, reverzibilna redukcija duljine dugih kostiju i produljeni ciklus estrusa).
English: The major excretion route is via urine, accounting for about 50% of the dose.
Croatian: Glavni put izlučivanja je putem mokraće na što otpada otprilike 50% doze.
English: - The active substance is macitentan.
Croatian: - Djelatna tvar je macitentan.
English: Summary of the safety profile.
Croatian: Sažetak sigurnosnog profila
English: Women should not become pregnant for 1 month after discontinuation of Opsumit.
Croatian: Žene ne smiju zatrudnjeti tijekom mjesec dana nakon prekida liječenja lijekom Opsumit.
English: Intimal thickening of coronary arteries was observed at 17-fold the human exposure after 4 to 39 weeks of treatment.
Croatian: Zadebljanje intime koronarnih arterija uočeno je pri 17 puta većoj izloženosti nego kod ljudi nakon 4 do 39 tjedana liječenja.
English: Swallow the whole tablet, with a glass of water, do not chew or break the tablet.
Croatian: Progutajte tabletu cijelu, s čašom vode, nemojte žvakati ili lomiti tabletu.
English: The Healthcare Professionals brochure should contain the following key elements:
Croatian: Brošura za zdravstvene djelatnike treba sadržavati sljedeće ključne elemente:
English: Thereafter, plasma concentrations of macitentan and its active metabolite decrease slowly, with an apparent elimination half-life of approximately 16 hours and 48 hours, respectively.
Croatian: Stoga se plazmatske koncentracije macitentana i njegovog aktivnog metabolita smanjuju polako s prividnim poluvijekom eliminacije od približno 16 odnosno 48 sati.
English: • That pregnant women must not take Opsumit;
Croatian: • Trudnice ne smiju uzimati Opsumit;
English: No testicular findings were noted in mice after treatment up to 2 years.
Croatian: Nisu uočene nikakve promjene na testisima u miševa nakon liječenja u trajanju do dvije godine.
English: There are no data from the use of macitentan in pregnant women.
Croatian: Nema podataka o primjeni macitentana u trudnica.
English: For more information on Opsumit, please read carefully the patient information leaflet.
Croatian: Za više informacija o lijeku Opsumit molimo pažljivo pročitajte
English: Contents of the pack and other information What Opsumit contains
Croatian: Sadržaj pakiranja i druge informacije Što Opsumit sadrži
English: • The need for monthly pregnancy tests;
Croatian: • Potreba mjesečnih testova na trudnoću;
English: If you have signs of pulmonary oedema when using Opsumit, such as a sudden, important increase in breathlessness and low oxygen, tell your doctor immediately.
Croatian: Ako kod uzimanja lijeka Opsumit imate znakove plućnog edema, poput iznenadnog, značajno pojačanog nedostatka zraka i smanjenog unosa kisika, odmah obavijestite svog liječnika.
English: The effect of macitentan on human male fertility is not known (section 4.6).
Croatian: Nije poznat učinak macitentana na plodnost muškaraca (dio 4.6).
English: In healthy subjects, the exposure to macitentan and its active metabolite is unchanged in the presence of food and, therefore, macitentan may be taken with or without food.
Croatian: U zdravih ispitanika, izloženost macitentanu i njegovom aktivnom metabolitu nije izmijenjena u prisutnosti hrane i stoga se macitentan može uzimati s hranom ili bez nje.
English: The predicted increase was approximately 3fold in the presence of ketoconazole 200 mg twice daily using physiologically based pharmacokinetic (PBPK) modelling.
Croatian: Predviđeno povećanje bilo je približno trostruko u prisutnosti ketokonazola u dozi od 200 mg dvaput dnevno, uz korištenje fiziološki osnovanog farmakokinetičkog modeliranja (PBPK).
English: • The need for regular monitoring of liver function because Opsumit has hepatotoxic potential.
Croatian: • Potreba za redovitim praćenjem funkcije jetre, jer Opsumit ima hepatotoksični potencijal.
English: • whether your liver is working properly
Croatian: • radi li Vam jetra ispravno
English: The majority of adverse reactions are mild to moderate in intensity.
Croatian: Većina nuspojava su blagog do umjerenog intenziteta.
English: This lowers the blood pressure, relieves the symptoms and improves the course of the disease.
Croatian: To snižava krvni tlak, olakšava simptome te poboljšava tijek bolesti.
English: 4.6 Fertility, pregnancy, and lactation
Croatian: 4.6 Plodnost, trudnoća i dojenje
English: a = based on Cox's Proportional Hazards Model b = % of patients with an event at 36 months = 100 × (1 - KM estimate) c= all cause death up to EOT regardless of prior worsening
Croatian: a = na temelju Coxova modela proporcionalnog hazarda b = % bolesnika s događajem u 36. mjesecu = 100 × (1 - KM procjena) c = svi uzroci smrti do kraja liječenja neovisno o prijašnjem pogoršanju
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); not known (cannot be estimated from the available data).
Croatian: < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: • Healthcare Professional brochure containing information about Opsumit;
Croatian: • Brošuru za zdravstvene djelatnike koja sadrži informacije o lijeku Opsumit;
English: Oxidative depropylation of the sulfamide yields a pharmacologically active metabolite.
Croatian: Oksidativna depropilacija sulfamida daje farmakološki aktivni metabolit.
English: • fatigue/malaise/weakness
Croatian: • omaglica • umor/malaksalost/slabost
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 drugog sustava glasnika koja uzrokuje vazokonstrikciju i proliferaciju stanica glatkih mišića.
English: Increased liver weight and hepatocellular hypertrophy were observed in mice, rats and dogs after treatment with macitentan.
Croatian: Povećana težina jetre i hepatocelularna hipertrofija uočene su u miševa, štakora i pasa nakon liječenja macitentanom.
English: The requirements for submission of periodic safety updated reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: • Periodička izvješća o neškodljivosti Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: In dogs, macitentan decreased blood pressure at exposures similar to the therapeutic human exposure.
Croatian: U pasa je macitentan smanjio krvni tlak pri izloženosti sličnoj terapijskoj izloženosti u ljudi.
English: Macitentan is only excreted after extensive metabolism.
Croatian: Macitentan se izlučuje samo nakon opsežnog metabolizma.
English: Opsumit should only be prescribed by a doctor experienced in the treatment of pulmonary arterial hypertension.
Croatian: Opsumit smije propisati samo liječnik s iskustvom u liječenju plućne arterijske hipertenzije.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija In vitro ispitivanja
English: Monthly pregnancy tests during treatment with Opsumit are recommended to allow the early detection of pregnancy.
Croatian: Preporučuju se mjesečni testovi na trudnoću tijekom liječenja lijekom Opsumit kako bi se omogućilo rano otkrivanje trudnoće.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with macitentan in all subsets of the paediatric population for PAH (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja macitentana u svim podskupinama pedijatrijske populacije za odobrenu indikaciju PAH (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Reinitiation of Opsumit may be considered following the return of hepatic enzyme levels to within the normal range in patients who have not experienced clinical symptoms of liver injury.
Croatian: Nastavak liječenja lijekom Opsumit može se uzeti u obzir nakon povratka razina jetrenih enzima unutar normalnog raspona u bolesnika koji nisu iskusili kliničke simptome oštećenja jetre.
English: Please talk to your doctor or pharmacist if you are taking any of the following medicines:
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate bilo koji od sljedećih lijekova:
English: Therefore Opsumit should be used with caution in this population (see section 4.4).
Croatian: Stoga u toj populaciji Opsumit treba koristiti oprezno (vidjeti dio 4.4).
English: SPECIAL STORAGE CONDITIONS Do not store above 30 °C
Croatian: POSEBNE MJERE ČUVANJA Ne čuvati na temperaturi iznad 30°C
English: In rats, macitentan and its metabolites are excreted into milk during lactation (see section 5.3).
Croatian: U štakora, macitentan i njegovi metaboliti izlučuju se u mlijeko tijekom laktacije (vidjeti dio 5.3).
English: Opsumit is used for the long-term treatment of pulmonary arterial hypertension (PAH) in adults; it can be used on its own or with other medicines for PAH.
Croatian: Opsumit se koristi za dugoročno liječenje plućne arterijske hipertenzije (PAH) u odraslih osoba; može se koristiti samostalno ili u kombinaciji s drugim lijekovima za liječenje PAH-a.
English: The MAH shall agree the details of the Prescriber kit and a controlled distribution system with the National Competent Authority and implement it prior to launch in that Member State.
Croatian: Nositelj odobrenja će dogovoriti pojedinosti Kompleta za propisivača lijeka i kontrolirani sustav distribucije s nadležnim nacionalnim tijelom i morat će ga uvesti prije stavljanja lijeka na tržište te države članice.
English: • if you are pregnant, if you are planning to become pregnant, or if you could become pregnant because you are not using reliable birth control (contraception).
Croatian: • ako ste trudni, ako planirate zatrudnjeti ili ako biste mogli zatrudnjeti jer ne koristite pouzdanu metodu kontrole začeća (kontracepcija).
English: If you stop taking Opsumit
Croatian: Ako prestanete uzimati Opsumit
English: Opsumit is supplied as 10 mg film-coated tablets in blister packs of 15 or 30 tablets, or in bottles of 30 tablets.
Croatian: Opsumit se isporučuje kao filmom obložena tableta od 10 mg u blister pakiranju od 15 ili 30 tableta ili u boci od 30 tableta.
English: Opsumit can cause side effects such as headaches and hypotension (listed in section 4), and the symptoms of your condition can also make you less fit to drive.
Croatian: Opsumit može uzrokovati nuspojave poput glavobolje i sniženog krvnog tlaka (navedene u dijelu 4), i simptomi Vašeg stanja Vas također mogu učiniti manje sposobnima za vožnju.
English: Excipients with known effect:
Croatian: Pomoćne tvari s poznatim učinkom
English: If you have anaemia (a reduced number of red blood cells), you may have the following signs:
Croatian: Ako imate anemiju (smanjeni broj crvenih krvnih stanica), možete imati sljedeće znakove:
English: • If you become pregnant or think that you may be pregnant while you are taking Opsumit, or shortly after stopping Opsumit (up to 1 month), see your doctor immediately.
Croatian: • Ako zatrudnite ili mislite da biste mogli zatrudnjeti dok uzimate Opsumit, ili kratko nakon prekida uzimanja lijeka Opsumit (do 1 mjeseca), odmah potražite svog liječnika.
English: It is recommended that haemoglobin concentrations be measured prior to initiation of treatment and tests repeated during treatment as clinically indicated.
Croatian: Preporučuje se mjerenje koncentracija hemoglobina prije početka liječenja uz ponavljanje tijekom liječenja kako je klinički indicirano.
English: • That patients should be capable of complying with the requirements for the safe use of Opsumit;
Croatian: • Bolesnici moraju biti sposobni postupati prema zahtjevima za sigurnu primjenu lijeka Opsumit;
English: The most commonly reported adverse reactions are nasopharyngitis (14%), headache (13.6%) and anaemia (13.2%, see section 4.4).
Croatian: Najčešće prijavljene nuspojave bile su nazofaringitis (14%), glavobolja (13,6%) i anemija (13,2%,
English: The mean age of all patients was 46 years (range 12-85 years of age, including 20 patients below 18, 706 patients between 18-74 years, and 16 patients aged 75 and older) with the majority of subjects being Caucasian (55%) and female (77%).
Croatian: Prosječna dob svih bolesnika iznosila je 46 godina (raspon 12-85 godina uključujući 20 bolesnika mlađih od 18 godina, 706 bolesnika u dobi između 18 i 74 godine i 16 bolesnika u dobi od 75 godina i starijih) dok je većina ispitanika bila bijele rase (55%) i ženskog spola (77%).
English: Pulmonary veno-occlusive disease
Croatian: Plućna veno-okluzivna bolest
English: For the treatment of pulmonary arterial hypertension
Croatian: Za liječenje plućne arterijske hipertenzije
English: You should have a pregnancy test before initiation of Opsumit and every month during treatment even if you think that you are not pregnant.
Croatian: Testiranju na trudnoću se morate podvrgnuti prije početka liječenja lijekom Opsumit te svakog mjeseca tijekom liječenja, čak i ako mislite da niste trudni.
English: The overall median double-blind treatment duration was 115 weeks (up to a maximum of 188 weeks on macitentan).
Croatian: 115 tjedana (do maksimalno 188 tjedana na macitentanu).
English: The patient should be told not to take two doses at the same time if a dose has been missed.
Croatian: Bolesniku je potrebno reći da u slučaju propuštene doze ne smije uzeti dvije doze istovremeno.
English: In disease conditions such as PAH, the local ET system is upregulated and is involved in vascular hypertrophy and in organ damage.
Croatian: U uvjetima bolesti poput PAH-a, lokalni ET sustav je brojčano pojačan te je uključen u vaskularnu hipertrofiju i oštećenje organa.
English: If you are a woman who could become pregnant, your doctor will ask you to take a pregnancy test before you start taking Opsumit and regularly (once a month) while you are taking Opsumit.
Croatian: Ako ste žena koja bi mogla zatrudnjeti, Vaš liječnik će od Vas tražiti da obavite testiranje na trudnoću prije početka uzimanja lijeka Opsumit te redovito (jednom mjesečno) sve dok uzimate Opsumit.
English: Macitentan is an orally active potent endothelin receptor antagonist, active on both ETA and ETB receptors and approximately 100-fold more selective for ETA as compared to ETB in vitro.
Croatian: Macitentan je peroralno aktivan, potentan antagonist endotelinskih receptora aktivan na ETA i na ETB receptorima i približno 100 puta selektivniji za ETA u usporedbi s ETB in vitro.
English: • Patients with severe hepatic impairment (with or without cirrhosis) (see section 4.2).
Croatian: • Bolesnici s teškim oštećenjem jetre (s cirozom ili bez nje) (vidjeti dio 4.2).
English: • Oedema (swelling), especially of the ankles and feet
Croatian: • edem (oticanje), naročito gležnjeva i stopala
English: No studies on the effects on the ability to drive and use machines have been performed.
Croatian: Nisu obavljena ispitivanja učinaka na sposobnost upravljanja vozilima i rada sa strojevima.
English: Hormonal contraceptives: Macitentan 10 mg once daily did not affect the pharmacokinetics of an oral contraceptive (norethisterone 1 mg and ethinyl estradiol 35 µg).
Croatian: Hormonski kontraceptivi: Macitentan u dozi od 10 mg jednom dnevno nije utjecao na farmakokinetiku oralnog kontraceptiva (noretisteron 1 mg i etinilestradiol 35 µg).
English: At baseline, the majority of enrolled patients (64%) were treated with a stable dose of specific therapy for PAH, either oral phosphodiesterase inhibitors (61%) and/or inhaled/oral prostanoids (6%).
Croatian: Na početku, većina uključenih bolesnika (64%) liječeni su stabilnom dozom specifične terapije za PAH, bilo oralnim inhibitorima fosfodiesteraze (61%) i/ili inhaliranim/oralnim prostanoidima (6%).
English: • The need for baseline and monthly pregnancy tests and monitoring of haemoglobin levels and liver function.
Croatian: • Potrebno je početno i mjesečno testiranje na trudnoću te praćenje razina hemoglobina i funkcije jetre.
English: Opsumit may harm the development of the foetus.
Croatian: Trudnoća Opsumit može štetno djelovati na razvoj fetusa.
English: Do not use Opsumit after the expiry date which is stated on the carton, bottle and blister after “EXP”.
Croatian: Opsumit se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, boci i blisteru iza oznake „Rok valjanosti“ ili „EXP“.
English: If you forget to take Opsumit
Croatian: Ako ste zaboravili uzeti Opsumit
English: If you notice any of these signs, tell your doctor immediately.
Croatian: Ukoliko primijetite ijedan od ovih znakova, odmah obavijestite svog liječnika.
English: This reaction is dependent on the cytochrome P450 system, mainly CYP3A4 (approximately 99%) with minor contributions of CYP2C8, CYP2C9 and CYP2C19.
Croatian: Ova reakcija ovisi o sustavu citokroma P450, uglavnom CYP3A4 (približno 99%) s manjim doprinosima CYP2C8, CYP2C9 i CYP2C19.
English: The recommended dose is 10 mg once daily.
Croatian: Preporučena doza je 10 mg jednom dnevno.
English: Macitentan was not phototoxic in vivo after single dose at exposures of up to 24-fold the human exposure.
Croatian: Macitentan nije bio fototoksičan in vivo nakon pojedinačne doze pri izloženosti do 24 puta većoj od izloženosti u ljudi.
English: 1Data derived from pooled placebo-controlled studies.
Croatian: 1Podaci izvedeni iz objedinjenih placebom kontroliranih ispitivanja.
English: There is limited clinical experience with macitentan in patients over the age of 75 years, therefore Opsumit should be used with caution in this population (see section 4.2).
Croatian: Kliničko iskustvo s macitentanom je ograničeno u bolesnika starijih od 75 godina pa se stoga Opsumit treba koristiti oprezno u ovoj populaciji (vidjeti dio 4.2).
English: Therefore you must not take Opsumit if you are pregnant and you must also not become pregnant while taking Opsumit.
Croatian: Opsumit ako ste trudni i također ne smijete zatrudnjeti dok uzimate Opsumit.
English: Idiopathic or heritable PAH was the most common aetiology in the study population (57%), followed by PAH due to connective tissue disorders (31%), PAH associated with corrected simple congenital heart disease (8%), and PAH associated with other aetiologies (medicinal products and toxins [3%] and HIV [1%]).
Croatian: Idiopatski ili nasljedni PAH bio je najčešća etiologija u populaciji ispitivanja (57%), nakon čega je slijedio PAH zbog bolesti vezivnog tkiva (31%), PAH povezan s korigiranom jednostavnom srčanom manom (8%) i PAH povezan s drugim etiologijama (lijekovi i toksini [3%] i HIV [1%]).
English: 5 Haemoglobin
Croatian: 5 Hemoglobin
English: Liver enzyme tests should be obtained prior to initiation of Opsumit.
Croatian: Testove jetrenih enzima treba provesti prije početka liječenja Opsumitom.
English: 5.5 mm, round, biconvex, white to off-white film-coated tablets, debossed with “10” on both sides.
Croatian: 5,5 mm, okrugle, bikonveksne, bijele do gotovo bijele filmom obložene tablete, s oznakom „10” na obje strane.
English: Nasal congestion1
Croatian: Često kongestija nosa1
English: Cases of anaemia requiring blood cell transfusion have been reported with macitentan and other ERAs.
Croatian: Slučajevi anemije koji su zahtijevali transfuziju krvnih pripravaka zabilježeni su s macitentanom i drugim ERA-ovima.
English: • Baseline values of hepatic aminotransferases (aspartate aminotransferases (AST) and/or alanine aminotransferases (ALT) > 3 × ULN) (see sections 4.2 and 4.4).
Croatian: • Početne vrijednosti jetrenih aminotransferaza (aspartat-aminotransferaza (AST) i/ili alanin aminotransferaza (ALT) > 3 × GGN) (vidjeti dijelove 4.2 i 4.4).
English: BATCH NUMBER, DONATION AND PRODUCT CODES Lot
Croatian: 4. BROJ SERIJE, OZNAKE DONACIJE I PROIZVODA Lot
English: INFORMATION IN BRAILLE Opsumit 10 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Opsumit 10 mg
English: Cartons containing 1 bottle of 30 film-coated tablets.
Croatian: Kutijama koje sadrže 1 bocu s 30 filmom obloženih tableta.
English: • To provide patients with the patient card;
Croatian: • Bolesnicima dati karticu za bolesnika;
English: Patients with renal impairment may run a higher risk of experiencing hypotension and anaemia during treatment with macitentan.
Croatian: Bolesnici s oštećenjem bubrega mogu biti pod povećanim rizikom od hipotenzije i anemije tijekom liječenja macitentanom.
English: Consequently, if signs of pulmonary oedema occur when macitentan is administered in patients with PAH, the possibility of pulmonary veno-occlusive disease should be considered.
Croatian: Shodno tome, ako se pojave znakovi plućnog edema kad se macitentan primjenjuje u bolesnika s PAH-om, potrebno je uzeti u obzir mogućnost plućne veno-okluzivne bolesti.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 December 2013
Croatian: Datum prvog odobrenja: 20. prosinca 2013.
English: • regular monitoring of liver function;
Croatian: • redovitim praćenjem funkcije jetre;
English: If a patient is hypersensitive to soya, Opsumit must not be used (see section 4.3).
Croatian: Ako je bolesnik preosjetljiv na soju, Opsumit se ne smije koristiti (vidjeti dio 4.3).
English: Opsumit contains the active substance macitentan, which belongs to the class of medicines called “endothelin receptor antagonists”.
Croatian: Opsumit sadrži djelatnu tvar macitentan koja pripada skupini lijekova zvanih „antagonisti receptora endotelina“.
English: Macitentan was not genotoxic in a standard battery of in vitro and in vivo assays.
Croatian: Macitentan se nije pokazao genotoksičan u standardnoj bateriji in vitro i in vivo testova.