natgillin/translations-raw huggingface dataset:
The relevance of this finding to humans is unknown, but a deterioration of spermatogenesis cannot be excluded. 
Pomen tega izsledka za ljudi ni znan, vendar poslabšanja spermatogeneze ni mogoče izključiti.
ATC code: C02KX04. 
oznaka ATC: C02KX04.
It is best to take the tablet at the same time each day. 
Najbolje je, da tableto vzamete vsak dan ob istem času.
Patient Card Page 1 (front) 
Opozorilna kartica za bolnika Stran 1 (sprednja stran)
A risk to the breastfeeding child cannot be excluded. 
Tveganja za dojenega otroka ne moremo izključiti.
Exercise capacity was evaluated as a secondary endpoint. 
Zmožnost vadbe so ocenili kot sekundarni opazovani dogodek.
Caution is recommended in this population. 
Pri tej populaciji se priporoča previdnost.
You will need blood tests, as indicated by your doctor: 
Potrebovali boste krvne preiskave, kot vam je povedal zdravnik:
6 White blood cells 
6 Bele krvne celice
Due to the species-specific sensitivity and the safety margin, this finding is considered not relevant for humans. 
Zaradi občutljivosti, specifične za živalsko vrsto, in varnostne meje se ta izsledek ne smatra kot pomemben za ljudi.
The safety margins for fertility were 18 for male and 44 for female rats. 
Varnostna meja za plodnost je bila 18 za samce in 44 za samice podgan.
Page 2 
Stran 2
Summary of the safety profile. 
Povzetek varnostnega profila
Date of latest renewal: 23 August 2018 
Datum prve odobritve: 20. december 2013 Datum zadnjega podaljšanja: 23 Avgust 2018
• Allergic reactions (swelling around the eyes, face, lips, tongue or throat, itching and/or rash) If you notice any of these signs, tell your doctor immediately. 
• alergijske reakcije (otekle oči, obraz, ustnice, jezik ali grlo, srbenje in/ali izpuščaj) Če opazite katerega od teh znakov, takoj obvestite zdravnika.
• if you have liver disease or if you have very high levels of liver enzymes in your blood. 
• če imate bolezen jeter ali če imate zelo visoke vrednosti jetrnih encimov v krvi.
Macitentan has four primary metabolic pathways. 
Macitentan ima štiri primarne presnovne poti.
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). 
Pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Talk to your doctor about this. 
O tem se pogovorite z zdravnikom.
Opsumit can affect other medicines. 
Zdravilo Opsumit lahko vpliva na druga zdravila.
Absolute risk reduction 
Zmanjšan je absolutne ga tveganja
Other metabolic pathways yield products without pharmacological activity. 
Druge presnovne poti dajejo produkte brez farmakološke aktivnosti.
Exposure to the active metabolite of macitentan was reduced by 26%. 
Izpostavljenost aktivnemu presnovku macitentana se je zmanjšala za 26 %.
Your doctor may perform additional tests, and will determine what treatment regimen is most suitable for you. 
Zdravnik bo morda opravil dodatne preiskave in ugotovil, kateri režim zdravljenja je za vas najbolj primeren.
The overall median double-blind treatment duration was 115 weeks (up to a maximum of 188 weeks on macitentan). 
Splošno mediano trajanje dvojno slepega zdravljenja je bilo 115 tednov (do največ 188 tednov na macitentanu).
This causes people to feel tired, dizzy, and short of breath. 
Zaradi tega se ljudje počutijo utrujene, omotične in zasople.
What Opsumit is and what it is used for 2. 
Kaj je zdravilo Opsumit in za kaj ga uporabljamo 2.
• The risk of anaemia, hepatotoxicity and teratogenicity and the need for reliable contraception; 
• obstoj tveganja za anemijo, hepatotoksičnosti in teratogenost ter potrebo po učinkoviti kontracepciji;
The patient should be told not to take two doses at the same time if a dose has been missed. 
Bolniku je treba povedati, da naj ne vzame dveh odmerkov hkrati, če je kateri odmerek izpustil.
Do not stop taking Opsumit unless you have agreed this with your doctor. 
Zdravila Opsumit ne prenehajte jemati, če se niste tako dogovorili z zdravnikom.
Do not give this medicine to children and adolescents below 18 years because Opsumit has not been tested in children. 
Tega zdravila ne dajajte otrokom in mladostnikom, starim manj kot 18 let, saj zdravilo Opsumit ni bilo preiskušeno pri otrocih.
or subcutaneous (s.c.) prostanoids, or other worsening of PAH. 
ali subkutanih (s.c.) prostanoidov ali drugo poslabšanje PAH.
Talk to your doctor, who will decide whether this medicine is suitable for you. 
Posvetujte se z zdravnikom, ki se bo odločil, ali je to zdravilo za vas primerno.
No studies on the effects on the ability to drive and use machines have been performed. 
Študij učinkov na sposobnost vožnje in upravljanja strojev niso izvedli.
Macitentan is not a substrate for Pgp/MDR-1. 
Macitentan ni substrat za P-gp/MDR-1.
• The need for baseline and: 
• Potrebo po izhodiščnem in:
Due to the high degree of protein binding of macitentan, dialysis is unlikely to be effective. 
Zaradi visoke stopnje vezave macitentana na beljakovine ni verjetno, da bi bila dializa učinkovita.
The increase in 6MWD achieved with macitentan was maintained for the duration of the study. 
Zvišanje 6MWD, doseženo z macitentanom, se je ohranilo ves čas trajanja študije.
Patients should be monitored for signs of hepatic injury and monthly monitoring of ALT and AST is recommended. 
Bolnike je treba spremljati za pojav znakov poškodbe jeter, priporoča pa se tudi mesečno spremljanje vrednosti ALT in AST.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine. 
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
There are no data from the use of macitentan in pregnant women. 
Podatkov o uporabi macitentana pri nosečnicah ni.
If you are allergic to soya, do not use this medicine (see section 2 ‘Do not take Opsumit'). 
Če ste alergični na sojo, ne uporabljajte tega zdravila (glejte poglavje 2 “Ne jemljite zdravila Opsumit”).
The active metabolite circulates in human plasma and may contribute to the pharmacological effect. 
Aktivni presnovek cirkulira v plazmi pri človeku in lahko prispeva k farmakološkemu učinku.
4 Liver aminotransferases 
4 Jetrne aminotransferaze
Macitentan 10 mg improved quality of life assessed by the SF-36 questionnaire. 
Macitentan 10 mg je glede na ocenitev z vprašalnikom SF-36 izboljšal kakovost življenja.
The recommended dose is 10 mg once daily. 
Priporočeni odmerek je 10 mg enkrat na dan.
Opsumit should be used with caution in this age group. 
Zdravilo Opsumit je treba v tej starostni skupini uporabljati previdno.
Carry this card with you at all times and show it to any doctor involved in your medical care. 
Kartico vedno nosite s seboj in jo pokažite vsakemu zdravniku, ki vas zdravi.
Moreover, if you are suffering from pulmonary arterial hypertension, the occurrence of a pregnancy can severely deteriorate the symptoms of your disease. 
Če imate pljučno arterijsko hipertenzijo, lahko nosečnost močno poslabša simptome vaše bolezni.
The Healthcare Professionals brochure should contain the following key elements: 
Brošura za zdravstvene delavce mora vsebovati naslednje ključne elemente:
Table 1 Summary of outcome events 
Preglednica 1 Povzetek dogodkov
• pain in your stomach (abdomen) 
• bolečine v trebuhu (abdomnu)
4.7 Effects on ability to drive and use machines Macitentan has minor influence on the ability to drive and use machines. 
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Macitentan ima blag vpliv na sposobnost vožnje in upravljanja strojev.
• if you are allergic to macitentan, soya or any of the other ingredients of this medicine (listed in section 6). 
• če ste alergični na macitentan, sojo ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
What you need to know before you take Opsumit 3. 
Kaj morate vedeti, preden boste vzeli zdravilo Opsumit 3.
The film-coated tablets are not breakable and are to be swallowed whole, with water. 
Način uporabe Filmsko obloženih tablet ni mogoče prelomiti in jih je treba cele pogoltniti z vodo.
The effect of macitentan on human male fertility is not known (section 4.6). 
Učinek macitentana na plodnost pri ljudeh za moške ni znan (poglavje 4.6).
• fast heart rate, palpitations 
• hiter srčni utrip, palpitacije
• Do not take Opsumit if you are pregnant or planning to become pregnant. 
• Ne jemljite zdravila Opsumit, če ste noseči ali načrtujete zanositev.
• Elevated liver tests 
• zvišane ravni jetrnih testov
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. 
Bolniki z redko dedno intoleranco za galaktozo, popolnim pomanjkanjem laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
Opsumit should be taken every day at about the same time. 
Zdravilo Opsumit je treba jemati vsak dan ob istem času.
Relative risk reduction (97.5% CI) 
Zmanjšanje relativnega tveganja (97,5-% IZ)
Maximum plasma concentrations of macitentan are achieved about 8 hours after administration. 
Največje koncentracije macitentana v plazmi so bile dosežene približno 8 ur po uporabi.
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. 
Nato se koncentracije macitentana in njegovega aktivnega presnovka v plazmi počasi zmanjšujejo, z navideznim končnim razpolovnim časom približno 16 ur oz. 48 ur.
- The active substance is macitentan. 
- Učinkovina je macitentan.
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). 
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z macitentanom za vse podskupine pediatrične populacije za PAH (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
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 
a = na podlagi modela sorazmernosti ogroženosti po Coxu b = % bolnikov z dogodkom pri 36 mesecih = 100 × (1 - ocena po KM) c = smrt iz vseh vzrokov do konca zdravljenja, ne glede na predhodno poslabšanje
Efficacy in patients with pulmonary arterial hypertension 
Učinkovitost pri bolnikih s pljučno arterijsko hipertenzijo
Like other medicines of this class, Opsumit can induce anaemia (a reduced number of red blood cells) and can have effects on the liver. 
Kot vsa druga zdravila v tem razredu, lahko tudi zdravilo Opsumit povzroči anemijo (zmanjšano število rdečih krvnih celic) in vpliva na jetra.
4.6 Fertility, pregnancy, and lactation 
4.6 Plodnost, nosečnost in dojenje
Endothelin (ET)-1 and its receptors (ETA and ETB) mediate a variety of effects such as vasoconstriction, fibrosis, proliferation, hypertrophy, and inflammation. 
Endotelin (ET)-1 in njegova receptorja (ETA in ETB) posredujejo pri številnih učinkih, kot so vazokonstrikcija, fibroza, proliferacija, hipertrofija in vnetje.
Therefore, monitoring of blood pressure and haemoglobin should be considered. 
Zato se priporoča spremljanje krvnega tlaka in hemoglobina.
White, opaque PVC/PE/PVdC/Aluminium blisters in cartons containing 15 or 30 film-coated tablets. 
Bel, neprozoren pretisni omot iz PVC/PE/PVdC/aluminija v škatlah, ki vsebujejo po 15 ali 30 filmsko obloženih tablet.
If you take Opsumit together with other medicines including those listed below, the effects of Opsumit or the other medicines might be altered. 
Če zdravilo Opsumit uporabljate skupaj z drugimi zdravili, vključno s spodaj naštetimi, se lahko učinki zdravila Opsumit ali drugih zdravil spremenijo.
This lowers the blood pressure, relieves the symptoms and improves the course of the disease. 
S tem se krvni tlak zniža, kar olajša simptome in izboljša potek bolezni.
• Healthcare Professional brochure containing information about Opsumit; 
• brošuro za zdravstvene delavce, ki vsebuje informacije o zdravilu Opsumit;
In placebo-controlled studies, macitentan-related decreases in haemoglobin concentration were not progressive, stabilised after the first 4-12 weeks of treatment and remained stable during chronic treatment. 
V s placebom kontroliranih študijah z macitentanom povezano zmanjšanje koncentracij hemoglobina ni bilo progresivno in se je po prvih 4-12 tednih zdravljenja stabiliziralo, nato pa je ostalo med kroničnim zdravljenjem stabilno.
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. 
Pri zdravih osebah se izpostavljenost macitentanu in njegovemu aktivnemu presnovki v prisotnosti hrane ne spremeni, zato se lahko macitentan uporablja s hrano ali brez nje.
• That patients should be capable of complying with the requirements for the safe use of Opsumit; 
• bolnik mora biti sposoben izpolnjevati zahteve za varno uporabo zdravila Opsumit;
• Hypersensitivity to the active substance, soya or to any of the excipients listed in section 6.1. 
• Preobčutljivost na učinkovino, sojo ali katero koli pomožno snov, navedeno v poglavju 6.1.
What Opsumit is and what it is used for 
Kaj je zdravilo Opsumit in za kaj ga uporabljamo
Haemodynamic parameters were assessed in a subset of patients (placebo [N = 67], macitentan 10 mg [N = 57]) after 6 months of treatment. 
Hemodinamske parametre so ocenili v podskupini bolnikov (placebo [N = 67], macitentan 10 mg [N = 57]) po 6 mesecih zdravljenja.
INFORMATION IN BRAILLE Opsumit 10 mg 
PODATKI V BRAILLOVI PISAVI Opsumit 10 mg
The primary endpoint was the time to first occurrence of a morbidity or mortality event, up to the end of double-blind treatment, defined as death, or atrial septostomy, or lung transplantation, or initiation of intravenous (i.v.) 
Primarni opazovani dogodek je bil čas do prvega pojava dogodka obolevnosti ali smrtnosti, do konca dvojno slepega zdravljenja, ki je bil opredeljen kot smrt ali atrijska septostomija ali presaditev pljuč ali uvedba intravenskih (i.v.)
They may be taken with or without food. 
Jemati jih je možno s hrano ali brez nje.
The predicted increase was approximately 3fold in the presence of ketoconazole 200 mg twice daily using physiologically based pharmacokinetic (PBPK) modelling. 
Predvideno zvišanje je bilo približno 3-kratno v prisotnosti ketokonazola 200 mg dvakrat na dan z uporabo fiziološkega modela farmakokinetičnega modeliranja (PBPK).
The Prescribing Checklist should remind prescribers of the contraindications, warnings and precautions as well as the following key elements: 
Kontrolni seznam za predpisovanje zdravila bo zdravnike, ki zdravilo predpisujejo, opozarjal na kontraindikacije, opozorila in previdnostne ukrepe ter na naslednje ključne elemente:
The most commonly reported adverse reactions are nasopharyngitis (14%), headache (13.6%) and anaemia (13.2%, see section 4.4). 
Neželeni učinki, o katerih so najpogosteje poročali, so nazofaringitis (14 %), glavobol (13,6 %) in anemija (13,2 %, glejte poglavje 4.4).
Page 6 (back) 
Stran 6 (hrbtna stran)
EOS was declared when the predefined number of primary endpoint events was reached. 
Konec študije je bil določen, ko je bilo doseženo vnaprej določeno število dogodkov primarnega opazovanega dogodka.
See section ‘Pregnancy and breastfeeding'. 
Glejte poglavje “Nosečnost in dojenje”.
• The need for baseline and monthly pregnancy tests and monitoring of haemoglobin levels and liver function. 
• da morajo na začetku in nato vsak mesec opravljati teste nosečnosti in nadzirati ravni hemoglobina in delovanje jeter.
The safety of macitentan has been evaluated in a long-term placebo-controlled trial of 742 patients with symptomatic PAH. 
Varnost macitentana so ocenili v dolgoročnem s placebom kontroliranem preskušanju s 742 bolniki s simptomatsko PAH.
• That Opsumit is teratogenic in animals; 
• da je zdravilo Opsumit teratogeno za živali;
Other medicines and Opsumit 
Druga zdravila in zdravilo Opsumit
Opsumit is a treatment that you will need to keep on taking to control your PAH. 
Zdravilo Opsumit je zdravljenje, ki ga boste morali za nadzor vaše PAH jemati ves čas.
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. 
Če se med uporabo zdravila Opsumit pojavijo znaki pljučnega edema, kot je nenadno, pomembno povečanje zasoplosti in in nizka raven kisika, nemudoma obvestite zdravnika.
• Patients with severe hepatic impairment (with or without cirrhosis) (see section 4.2). 
• Bolniki s hudo jetrno okvaro (s cirozo ali brez nje) (glejte poglavje 4.2).
If you notice any of these signs, tell your doctor immediately. 
Če opazite katerega koli od teh znakov, nemudoma obvestite zdravnika.
This prevents endothelin-mediated activation of second messenger systems that result in vasoconstriction and smooth muscle cell proliferation. 
Na ta način prepreči z endotelinom povzročeno aktivacijo sekundarnega sporočilnega sistema, ki ima za posledico vazokonstrikcijo in proliferacijo gladkih mišičnih celic.
These changes were largely reversible and considered non-adverse adaptations of the liver to increased metabolic demand. 
Te spremembe so bile v veliki meri reverzibilne in se smatrajo kot prilagoditev jeter na večje presnovne zahteve, kar ni neželen učinek.
• whether your liver is working properly 
• ali vaša jetra pravilno delujejo
Macitentan and its active metabolite ACT-132577 are well distributed into tissues as indicated by an apparent volume of distribution (Vss/F) of approximately 50 L and 40 L for macitentan and ACT-132577, respectively. 
Macitentan in njegov aktivni presnovek ACT-132577 se v tkivu dobro porazdelita, kot kaže navidezni volumen porazdelitve (Vss/F), ki je približno 50 l za macitentan in 40 l za ACT-132577.
• The importance of telling patients to report immediately any possible pregnancy that occurs during Opsumit use. 
• pomen takojšnjega poročanja možne nosečnosti, do katere pride med uporabo zdravila Opsumit.
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%). 
Povprečna starost vseh bolnikov je bila 46 let (razpon 12-85 starosti, vključno z 20 bolniki pod 18 let, 706 bolniki med 18-74 let in 16 bolniki, starimi 75 let in več), pri čemer je bila večina bolnikov belcev (55 %) in žensk (77 %).
• To provide patients with the patient card; 
• da bolnikom izročijo kartico za bolnika;
If you have anaemia (a reduced number of red blood cells), you may have the following signs: 
Če imate anemijo (zmanjšano število rdečih krvnih celic), imate morda naslednje znake:
If sustained, unexplained, clinically relevant aminotransferase elevations occur, or if elevations are accompanied by an increase in bilirubin > 2 × ULN, or by clinical symptoms of liver injury (e.g., jaundice), Opsumit treatment should be discontinued. 
Če se pojavijo trdovratna, nepojasnjena, klinično pomembna zvišanja aminotransferaz, ali če zvišanja spremlja zvišanje bilirubina > 2 × ULN ali klinični simptomi poškodbe jeter (npr. zlatenica), je treba zdravljenje z zdravilom Opsumit prekiniti.
The pharmacokinetics of macitentan and its active metabolite have mainly been documented in healthy subjects. 
Farmakokinetiko macitentana in njegovega aktivnega presnovka so dokumentirali pretežno pri zdravih osebah.
In disease conditions such as PAH, the local ET system is upregulated and is involved in vascular hypertrophy and in organ damage. 
Pri boleznih, kot je PAH, se lokalni sistem ET poveča in sodeluje pri žilni hipertrofiji in poškodovanju organov.
In dogs, macitentan decreased blood pressure at exposures similar to the therapeutic human exposure. 
Pri psih je macitentan znižal krvni tlak pri izpostavljenostih, podobnih terapevtski izpostavljenosti pri ljudeh.
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. 
Macitentan je peroralno aktiven močan antagonist receptorjev endotelina, ki učinkuje tako na receptorje ETA kot ETB in je in vitro približno 100-krat bolj selektiven za ETA v primerjavi z ETB.
Oxidative depropylation of the sulfamide yields a pharmacologically active metabolite. 
Rezultat oksidativne depropilacije sulfamida je farmakološko aktiven presnovek.
Logrank p-value 
Logrank vrednost p
Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH. 
Zdravljenje mora uvesti in nadzirati zdravnik z izkušnjami v zdravljenju PAH.
Opsumit may harm unborn babies conceived before, during or soon after treatment. 
Zdravilo Opsumit lahko poškoduje nerojenega otroka, spočetega pred zdravljenjem, med njim ali tik po njem.
Monthly pregnancy tests during treatment with Opsumit are recommended to allow the early detection of pregnancy. 
V času zdravljenja z zdravilom Opsumit se priporočajo mesečni testi nosečnosti za zgodnje prepoznavanje morebitne nosečnosti.
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). 
Dajanje macitentana mladim podganam od 4. dneva do 114. dneva po rojstvu je povzročilo zmanjšano pridobivanje telesne mase, kar je pri razvoju povzročilo sekundarne učinke (rahel zamik v spuščanju mod, reverzibilno zmanjšanje dolžine dolgih kosti, podaljšan estrusni cikel).
Hormonal contraceptives: Macitentan 10 mg once daily did not affect the pharmacokinetics of an oral contraceptive (norethisterone 1 mg and ethinyl estradiol 35 µg). 
Hormonski kontraceptivi: Macitentan 10 mg enkrat na dan ni vplival na farmakokinetiko peroralnega kontraceptiva (noretisteron 1 mg in etinilestradiol 35 µg).
Therefore Opsumit should be used with caution in this population (see section 4.4). 
Zato je treba zdravilo Opsumit v tej populaciji uporabljati previdno (glejte poglavje 4.4).
• monthly pregnancy tests; 
• mesečnem testu nosečnosti;
• Hypotension (low blood pressure) 
• hipotenzija (nizek krvni tlak)
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. 
Zdravilo Opsumit se uporablja za dolgotrajno zdravljenje pljučne arterijske hipertenzije (PAH) pri odraslih; uporablja se lahko samostojno ali z drugimi zdravili za zdravljenje PAH.
The mean treatment duration was 103.9 weeks in the macitentan 10 mg group, and 85.3 weeks in the placebo group. 
Povprečno trajanje zdravljenja je bilo 103,9 tedne v skupini z macitentanom 10 mg in 85,3 tednov v skupini s placebom.
This reaction is dependent on the cytochrome P450 system, mainly CYP3A4 (approximately 99%) with minor contributions of CYP2C8, CYP2C9 and CYP2C19. 
Ta reakcija je odvisna od sistema citokroma P450, pretežno CYP3A4 (približno 99 %) z manjšimi prispevki CYP2C8, CYP2C9 in CYP2C19.
Exposure to macitentan in patients with PAH was approximately 1.2-fold greater than in healthy subjects. 
Izpostavljenost macitentanu pri bolnikih s PAH je bila približno 1,2-krat večja kot pri zdravih osebah.
Opsumit is a registered trademark of Actelion Pharmaceuticals Ltd 
Opsumit je registrirana blagovna znamka družbe Actelion Pharmaceuticals Ltd
Macitentan and its active metabolite are not relevant substrates of OATP1B1 and OATP1B3, but enter the liver by passive diffusion. 
Macitentan in njegov aktivni presnovek nista pomembna substrata za OATP1B1 in OATP1B3, vendar vstopata v jetra s pasivno difuzijo.
Initiation of Opsumit is not recommended in patients with severe anaemia. 
Uvedba zdravila Opsumit se ne priporoča pri bolnikih s hudo anemijo.