FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: • The importance of telling patients to report immediately any possible pregnancy that occurs during Opsumit use.
Slovenian: • pomen takojšnjega poročanja možne nosečnosti, do katere pride med uporabo zdravila Opsumit.
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%).
Slovenian: 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 %).
English: • To provide patients with the patient card;
Slovenian: • da bolnikom izročijo kartico za bolnika;
English: If you have anaemia (a reduced number of red blood cells), you may have the following signs:
Slovenian: Če imate anemijo (zmanjšano število rdečih krvnih celic), imate morda naslednje znake:
English: 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.
Slovenian: 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.
English: The pharmacokinetics of macitentan and its active metabolite have mainly been documented in healthy subjects.
Slovenian: Farmakokinetiko macitentana in njegovega aktivnega presnovka so dokumentirali pretežno pri zdravih osebah.
English: In disease conditions such as PAH, the local ET system is upregulated and is involved in vascular hypertrophy and in organ damage.
Slovenian: Pri boleznih, kot je PAH, se lokalni sistem ET poveča in sodeluje pri žilni hipertrofiji in poškodovanju organov.
English: In dogs, macitentan decreased blood pressure at exposures similar to the therapeutic human exposure.
Slovenian: Pri psih je macitentan znižal krvni tlak pri izpostavljenostih, podobnih terapevtski izpostavljenosti pri ljudeh.
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.
Slovenian: 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.
English: Oxidative depropylation of the sulfamide yields a pharmacologically active metabolite.
Slovenian: Rezultat oksidativne depropilacije sulfamida je farmakološko aktiven presnovek.
English: Logrank p-value
Slovenian: Logrank vrednost p
English: Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH.
Slovenian: Zdravljenje mora uvesti in nadzirati zdravnik z izkušnjami v zdravljenju PAH.
English: Opsumit may harm unborn babies conceived before, during or soon after treatment.
Slovenian: Zdravilo Opsumit lahko poškoduje nerojenega otroka, spočetega pred zdravljenjem, med njim ali tik po njem.
English: Monthly pregnancy tests during treatment with Opsumit are recommended to allow the early detection of pregnancy.
Slovenian: V času zdravljenja z zdravilom Opsumit se priporočajo mesečni testi nosečnosti za zgodnje prepoznavanje morebitne nosečnosti.
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).
Slovenian: 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).
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).
Slovenian: Hormonski kontraceptivi: Macitentan 10 mg enkrat na dan ni vplival na farmakokinetiko peroralnega kontraceptiva (noretisteron 1 mg in etinilestradiol 35 µg).
English: Therefore Opsumit should be used with caution in this population (see section 4.4).
Slovenian: Zato je treba zdravilo Opsumit v tej populaciji uporabljati previdno (glejte poglavje 4.4).
English: • monthly pregnancy tests;
Slovenian: • mesečnem testu nosečnosti;
English: • Hypotension (low blood pressure)
Slovenian: • hipotenzija (nizek krvni tlak)
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.
Slovenian: Zdravilo Opsumit se uporablja za dolgotrajno zdravljenje pljučne arterijske hipertenzije (PAH) pri odraslih; uporablja se lahko samostojno ali z drugimi zdravili za zdravljenje PAH.
English: The mean treatment duration was 103.9 weeks in the macitentan 10 mg group, and 85.3 weeks in the placebo group.
Slovenian: Povprečno trajanje zdravljenja je bilo 103,9 tedne v skupini z macitentanom 10 mg in 85,3 tednov v skupini s placebom.
English: This reaction is dependent on the cytochrome P450 system, mainly CYP3A4 (approximately 99%) with minor contributions of CYP2C8, CYP2C9 and CYP2C19.
Slovenian: Ta reakcija je odvisna od sistema citokroma P450, pretežno CYP3A4 (približno 99 %) z manjšimi prispevki CYP2C8, CYP2C9 in CYP2C19.
English: Exposure to macitentan in patients with PAH was approximately 1.2-fold greater than in healthy subjects.
Slovenian: Izpostavljenost macitentanu pri bolnikih s PAH je bila približno 1,2-krat večja kot pri zdravih osebah.
English: Opsumit is a registered trademark of Actelion Pharmaceuticals Ltd
Slovenian: Opsumit je registrirana blagovna znamka družbe Actelion Pharmaceuticals Ltd
English: Macitentan and its active metabolite are not relevant substrates of OATP1B1 and OATP1B3, but enter the liver by passive diffusion.
Slovenian: Macitentan in njegov aktivni presnovek nista pomembna substrata za OATP1B1 in OATP1B3, vendar vstopata v jetra s pasivno difuzijo.
English: Initiation of Opsumit is not recommended in patients with severe anaemia.
Slovenian: Uvedba zdravila Opsumit se ne priporoča pri bolnikih s hudo anemijo.
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%).
Slovenian: Ob izhodišču so večino vključenih bolnikov (64 %) zdravili s stabilnim odmerkom specifičnega zdravila za PAH, bodisi s peroralnimi zaviralci fosfodiesteraze (61 %) in/ali inhalacijskimi/peroralnimi prostanoidi (6 %).
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.
Slovenian: • Če zanosite ali menite, da bi lahko bili noseči medtem ko jemljete zdravilo Opsumit ali kmalu po prenehanju jemanja zdravila Opsumit (do 1 meseca), se takoj posvetujte z zdravnikom.
English: SPECIAL STORAGE CONDITIONS Do not store above 30 °C
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 30 °C.
English: Macitentan and its active metabolite are highly bound to plasma proteins (> 99%), primarily to albumin and to a lesser extent to alpha1-acid glycoprotein.
Slovenian: Macitentan in njegov aktivni presnovek se v visoki meri vežeta na beljakovine v plazmi (> 99 %), pretežno na albumin in v manjšem obsegu na kisli alfa1 glikoprotein.
English: • fatigue/malaise/weakness
Slovenian: • utrujenost/splošno slabo počutje/šibkost
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.
Slovenian: Zdravilo Opsumit lahko povzroči neželene učinke, kot so glavoboli in hipotenzija (navedeni v poglavju 4), pa tudi zaradi simptomov vašega stanja ste morda manj sposobni voziti.
English: At 36 months, 44.6% of patients on placebo and 29.4% of patients on macitentan 10 mg (Absolute Risk Reduction = 15.2%) had been hospitalised for PAH or died from a PAH-related cause.
Slovenian: Pri 36 mesecih je bilo 44,6 % bolnikov na placebu in 29,4 % bolnikov na macitentanu 10 mg (absolutno zmanjšanje tveganja (ARR, Absolute Risk Reduction) = 15,2 %) hospitaliziranih zaradi PAH ali pa je umrlo zaradi vzrokov, povezanih s PAH.
English: If you have taken more tablets than you have been told to take, you may experience headache, nausea, or vomiting.
Slovenian: Če ste vzeli večji odmerek zdravila Opsumit, kot bi smeli Če ste vzeli več tablet, kot vam je bilo naročeno, se lahko pojavi glavobol, slabost ali bruhanje.
English: The safety and efficacy of macitentan in children and adolescents below 18 years have not yet been established.
Slovenian: Varnost in učinkovitost macitentana pri otrocih in mladostnikih, starih manj kot 18 let, še nista bili dokazani.
English: • To provide patients with appropriate information regarding the safe use of the product;
Slovenian: • da morajo bolnike ustrezno obvestiti o varni uporabi zdravila;
English: If you forget to take Opsumit, take a dose as soon as you remember, then continue to take your tablets at the usual times.
Slovenian: Če ste pozabili vzeti zdravilo, ga vzemite takoj, ko se spomnite, in nato s tabletami nadaljujte kot običajno.
English: Intimal thickening of coronary arteries was observed at 17-fold the human exposure after 4 to 39 weeks of treatment.
Slovenian: Intimalno odebelitev koronarnih arterij so po 4 do 39 tednov zdravljenja opazili pri izpostavljenosti, 17-krat večji od izpostavljenosti ljudi.
English: Macitentan may lead to more reduction of blood pressure and decrease in haemoglobin in patients with kidney problems.
Slovenian: Macitentan lahko povzroči znižanje krvnega tlaka in znižanje ravni hemoglobina pri bolnikih s težavami z ledvicami.
English: In the period between end-of-treatment (EOT) and EOS, patients could receive open-label macitentan 10 mg or alternative PAH therapy.
Slovenian: V obdobju med koncem zdravljenja in koncem študije so bolniki lahko prejemali odprto zdravljenje z macitentanom 10 mg ali alternativnim zdravilom za PAH.
English: After repeated administration, the pharmacokinetics of macitentan are dose-proportional up to and including 30 mg.
Slovenian: Po večkratnem dajanju je farmakokinetika macitentana sorazmerna z odmerkom do in vključno s 30 mg. Absorpcija
English: • Baseline values of hepatic aminotransferases (aspartate aminotransferases (AST) and/or alanine aminotransferases (ALT) > 3 × ULN) (see sections 4.2 and 4.4).
Slovenian: • Izhodiščne vrednosti jetrnih aminotransferaz (aspartat aminotransferaze (AST) in/ali alanin aminotransferaz (ALT) > 3 × ULN) (glejte poglavji 4.2 in 4.4).
English: The exposure to the active metabolite in patients, which is approximately 5-fold less potent than macitentan, was approximately 1.3-fold higher than in healthy subjects.
Slovenian: Izpostavljenost bolnikov aktivnemu presnovku, ki je približno 5-krat manj močan od macitentana, je bila približno 1,3-krat višja kot pri zdravih osebah.
English: 5.5 mm, round, biconvex, white to off-white film-coated tablets, debossed with “10” on both sides.
Slovenian: 5,5 mm, okrogle, bikonveksne, bele do belkaste filmsko obložene tablete, z vtisnjeno oznako ”10” na obeh straneh.
English: whether your liver is working properly
Slovenian: ali vaša jetra pravilno delujejo
English: Death c n (%)
Slovenian: Smrtc n (%)
English: Hypospermatogenesis was observed in the life-long carcinogenicity study in rats and in the repeatdose toxicity studies in dogs at exposures that provide safety margins of 9.7 in rats and 23 in dogs.
Slovenian: Hipospermatogenezo so opazili v doživljenjskih študijah kancerogenosti pri podganah in v študijah s ponavljajočimi odmerki pri psih pri izpostavljenostih z varnostno mejo 9,7 pri podganah in 23 pri psih.
English: In patients with pulmonary veno-occlusive disease (obstruction of the lung veins), the use of medicines for treatment of PAH, including Opsumit, may lead to pulmonary oedema.
Slovenian: Pri bolnikih s pljučno venookluzivno boleznijo (zapora pljučnih žil) lahko uporaba zdravil za zdravljenje PAH, vključno z zdravilom Opsumit, povzroči pljučni edem.
English: Efficacy of macitentan 10 mg on the primary endpoint was consistent across subgroups of age, sex, ethnic origin, geographical region, aetiology, by monotherapy or in combination with another PAH therapy and by WHO FC (I/II and III/IV).
Slovenian: Učinkovitost macitentana 10 mg ob primarni opazovani točki je bila v vseh podskupinah glede na starost, spol, etično pripadnost, geografsko regijo in vzrok konsistentna, bodisi kot monoterapija ali v kombinaciji z drugim zdravljenjem PAH, in glede na FR po SZO (I/II in III/IV).
English: Patients with renal impairment may run a higher risk of experiencing hypotension and anaemia during treatment with macitentan.
Slovenian: Bolniki z ledvično okvaro so morda med zdravljenjem z macitentanom bolj izpostavljeni tveganju hipotenzije in anemije.
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).
Slovenian: • če ste noseči, načrtujete nosečnost ali bi lahko zanosili, ker ne uporabljate učinkovitega načina preprečevanja nosečnosti (kontracepcije).
English: • ketoconazole (except shampoo), itraconazole, voriconazole (medicines used against fungal infections)
Slovenian: • ketokonazol (razen šampona), itrakonazol, vorikonazol (zdravila, ki se uporabljajo za zdravljenje glivičnih okužb).
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.
Slovenian: O ponovni uvedbi zdravila Opsumit lahko razmislimo, ko se ravni jetrnih encimov pri bolnikih, ki niso imeli kliničnih simptomov poškodbe jeter, vrnejo v normalni razpon.
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.
Slovenian: Pred uvedbo zdravljenja morate opraviti test nosečnosti, ki ga morate med zdravljenjem vsak mesec ponavljati, tudi če menite, da niste noseči.
English: It is not known if Opsumit is transferred to breast milk.
Slovenian: Ni znano, ali zdravilo Opsumit prehaja v materino mleko.
English: Opsumit should only be prescribed by a doctor experienced in the treatment of pulmonary arterial hypertension.
Slovenian: Zdravilo Opsumit vam sme predpisati samo zdravnik z izkušnjami v zdravljenju pljučne arterijske hipertenzije.
English: In people with PAH, these arteries get narrower, so the heart has to work harder to pump blood through them.
Slovenian: Pri ljudeh s PAH se te arterije zožijo, zato mora srce več delati, da skoznje načrpa kri.
English: If you forget to take Opsumit
Slovenian: Če ste pozabili vzeti zdravilo Opsumit
English: The major excretion route is via urine, accounting for about 50% of the dose.
Slovenian: Glavna pot izločanja je z urinom, ki predstavlja približno
English: Opsumit is supplied as 10 mg film-coated tablets in blister packs of 15 or 30 tablets, or in bottles of 30 tablets.
Slovenian: Zdravilo Opsumit je na voljo kot 10 mg filmsko obložene tablete v pretisnih omotih po 15 ali 30 tablet ali v plastenkah po 30 tablet.
English: • The need for monthly pregnancy tests;
Slovenian: • da je treba mesečno opravljati teste nosečnosti;
English: Macitentan was not phototoxic in vivo after single dose at exposures of up to 24-fold the human exposure.
Slovenian: Macitentan in vivo ni bil fototoksičen po enem odmerku v izpostavljenosti, ki je bila do 24-krat večja od izpostavljenosti pri ljudeh.
English: Each film-coated tablet contains approximately 37 mg of lactose (as monohydrate) and approximately 0.06 mg of soya bean lecithin (E322).
Slovenian: Ena filmsko obložena tableta vsebuje približno 37 mg laktoze (v obliki monohidrata) in približno 0,06 mg sojinega lecitina (E322).
English: • The Summary of Product Characteristics for Opsumit;
Slovenian: • povzetek glavnih značilnosti zdravila Opsumit;
English: Macitentan was not genotoxic in a standard battery of in vitro and in vivo assays.
Slovenian: Macitentan ni bil genotoksičen v standardnem nizu raziskav in vitro in in vivo.
English: No dose adjustment is required in patients over the age of 65 years (see section 5.2).
Slovenian: Prilagajanje odmerka pri bolnikih, starih več kot 65 let, ni potrebno (glejte poglavje 5.2).
English: It is recommended that haemoglobin concentrations be measured prior to initiation of treatment and tests repeated during treatment as clinically indicated.
Slovenian: da pred uvedbo zdravljenja izmerite koncentracije hemoglobina, nato pa preiskave med zdravljenjem ponavljate, kot je klinično indicirano.
English: • Oedema (swelling), especially of the ankles and feet
Slovenian: • edem (oteklina), zlasti gležnjev in stopal
English: This corresponded to 3.5 events / 100 patient-years on macitentan 10 mg compared to 2.7 events / 100 patient-years on placebo.
Slovenian: To ustreza 3,5 dogodkom/100 bolnikov-let pri macitentanu 10 mg v primerjavi z 2,7 dogodka/100 bolnikov-let pri placebu.
English: It is unknown whether macitentan is excreted in human milk.
Slovenian: Ni znano, ali se macitentan izloča v materino mleko.
English: Ketoconazole: In the presence of ketoconazole 400 mg once daily, a strong CYP3A4 inhibitor, exposure to macitentan increased approximately 2-fold.
Slovenian: Ketokonazol: V prisotnosti ketokonazola 400 mg enkrat na dan, močnim zaviralcem CYP3A4, se je izpostavljenost macitentanu zvišala za približno 2-krat.
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).
Slovenian: Izkušenj z macitentanom je pri bolnikih, starih več kot 75 let, malo, zato je treba zdravilo Opsumit pri tej populaciji uporabljati previdno (glejte poglavje 4.2).
English: The safety of macitentan in children and adolescents below 18 years has not yet been established.
Slovenian: Varnost macitentana pri otrocih in mladostnikih, starih manj kot 18 let, še nista bili dokazani.
English: - The other ingredients are lactose monohydrate (see section 2 “Opsumit contains lactose, lecithin from soya and sodium"), microcrystalline cellulose (E460i), povidone, sodium starch glycolate Type A (see section 2 “Opsumit contains lactose, lecithin from soya and sodium”), magnesium stearate (E572), polysorbate 80 (E433), polyvinyl alcohol (E1203), titanium dioxide (E171), talc (E553b), soya bean lecithin (E322) (see section 2 “Opsumit contains lactose, lecithin from soya and sodium") and xanthan gum (E415).
Slovenian: - Druge sestavine zdravila so laktoza monohidrat (glejte poglavje 2 “Zdravilo Opsumit vsebuje laktozo, sojin lecitin in natrij), mikrokristalna celuloza (E460i), povidon, natrijev karboksimetilškrob vrste A (glejte poglavje 2 “Zdravilo Opsumit vsebuje laktozo, sojin lecitin in natrij”), magnezijev stearat (E572), polisorbat 80 (E433), polivinilalkohol (E1203), titanov dioksid (E171), smukec (E553b), sojin lecitin (E322; glejte poglavje 2 “Zdravilo Opsumit vsebuje laktozo, sojin lecitin in natrij) in ksantanski gumi (E415).
English: If you stop taking Opsumit
Slovenian: Če ste prenehali jemati zdravilo Opsumit
English: • To ensure females of childbearing potential are not pregnant and are on reliable contraception prior to starting Opsumit;
Slovenian: • da se morajo prepričati, da ženske v rodni dobi niso noseče in da pred začetkom zdravljenja z zdravilom Opsumit uporabljajo učinkovito kontracepcijo;
English: Page 5 (inside right)
Slovenian: Stran 5 (znotraj desno)
English: The majority of adverse reactions are mild to moderate in intensity.
Slovenian: Večina neželenih učinkov je bila po intenzivnosti blaga do zmerna.
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.
Slovenian: • Dodatni ukrepi za zmanjševanje tveganj Imetnik dovoljenja za promet z zdravilom se bo s pristojnim nacionalnim organom dogovoril o vsebini kompleta za zdravnike, ki zdravilo predpisujejo, in glede nadzorovanega sistema razdeljevanja ter ga uvedel pred začetkom dajanja zdravila na trg v tej državi članici.
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.
Slovenian: Če ste ženska v rodni dobi, vas bo zdravnik prosil, da pred začetkom uporabe zdravila Opsumit opravite test nosečnosti, nato pa ga morate med uporabo zdravila Opsumit opravljati redno (enkrat mesečno).
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.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
English: • Prescribing checklists;
Slovenian: • kontrolni seznam za predpisovanje zdravila;
English: Contents of the pack and other information What Opsumit contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Opsumit
English: In both species there were cardiovascular and mandibular arch fusion abnormalities.
Slovenian: Pri obeh vrstah so opazili kardiovaskularne nenormalnosti in nenormalnosti v fuziji mandibularnega loka.
English: Carcinogenicity studies of 2 years' duration did not reveal a carcinogenic potential at exposures 18fold and 116-fold the human exposure in rats and mice, respectively.
Slovenian: Študije kancerogenosti, ki so trajale 2 leti, niso razkrile kancerogenega potenciala pri izpostavljenosti, ki je bila pri podganah 18-krat in pri miših 116-krat večja kot pri ljudeh.
English: Pharmacotherapeutic group: anti-hypertensives, anti-hypertensives for pulmonary arterial hypertension.
Slovenian: 5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: antihipertenzivi, antihipertenzivi za pljučno arterijsko hipertenzijo.
English: In rats, macitentan and its metabolites are excreted into milk during lactation (see section 5.3).
Slovenian: Pri podganah se macitentan in njegovi presnovki med dojenjem izločajo v mleko (glejte poglavje 5.3).
English: Leukopenia6
Slovenian: pogosti levkopenija6
English: Women should not become pregnant for 1 month after discontinuation of Opsumit.
Slovenian: Ženske še 1 mesec po prekinitvi uporabe zdravila
English: Administration of macitentan to female rats from late pregnancy through lactation at maternal exposures 5-fold the human exposure, caused reduced pup survival and impairment of the reproductive capability of the offspring, which was exposed to macitentan during late intrauterine life and via the milk during the suckling period.
Slovenian: Dajanje macitentana podganjim samicam od pozne nosečnosti in ves čas laktacije je pri izpostavljenosti matere, ki je bila 5-krat večja od izpostavljenosti pri ljudeh, povzročilo manjše preživetje mladičev in zmanjšano sposobnost razmnoževanja mladičev, ki so bili izpostavljeni macitentanu v poznem obdobju v maternici in z mlekom v obdobju laktacije.