FrancophonIA/ELRC3.0 huggingface dataset:
English: Safety margins for potential IP receptor-related effects on reproduction were 20 for fertility and 5 and 1 (based on free exposure) for embryo-foetal development in rats and rabbits, respectively, when adapted for differences in receptor potency.
Slovenian: Varnostne meje za možne učinke na sposobnost razmnoževanja, povezane z receptorjem IP, so bile 20 za razmnoževanje in 5 oz. 1 (na podlagi proste izpostavljenosti) za razvoj zarodka ali ploda pri podganah oz. kuncih po prilagoditvi za razlike v jakosti receptorja.
English: To improve tolerability, it is recommended to take Uptravi with food and, at the beginning of each up-titration phase, to take the first increased dose in the evening.
Slovenian: Za boljše prenašanje se priporoča jemanje zdravila Uptravi s hrano, na začetku vsake faze večanja odmerka pa naj bolnik prvi povečani odmerek vzame zvečer.
English: No clinically relevant effects of sex, race, age, or body weight on the pharmacokinetics of selexipag and its active metabolite have been observed in healthy subjects or PAH patients.
Slovenian: Klinično pomembnih učinkov spola, rase, starosti ali telesne mase na farmakokinetiko seleksipaga in njegovih aktivnih presnovkov pri zdravih osebah ali osebah s PAH niso opazili.
English: The cover letter to the healthcare professional should explain that the purpose of the educational materials is to reduce the risk of medication error due to the availability of multiple tablets and dose strengths, and it should provide a list of the contents of the Prescriber Kit.
Slovenian: Spremni dopis zdravstvenim delavcem mora vsebovati razlago, da je namen tega izobraževalnega gradiva zmanjševanje napak pri uporabi zdravila zaradi razpoložljivosti več različnih tablet in jakosti odmerkov, ter vsebovati seznam vsebine kompleta izobraževalnih gradiv za zdravnike, ki bodo zdravilo predpisovali.
English: If you have poor vision or experience any type of blindness, get help from another person when taking Uptravi during the titration period.
Slovenian: Če slabo vidite ali trpite za slepoto kakršne koli vrste, naj vam v obdobju titriranja zdravila Uptravi pomaga druga oseba.
English: HR (99% CI) p-value
Slovenian: RT (99-% IZ) vrednost p
English: Dialysis is unlikely to be effective because selexipag and its active metabolite are highly protein bound.
Slovenian: Ni verjetno, da bi dializa učinkovala, saj se seleksipag in njegov aktivni presnovek močno vežeta na beljakovine.
English: If confirmed, treatment with Uptravi should be discontinued.
Slovenian: Pri potrditvi je treba zdravljenje z zdravilom Uptravi prekiniti.
English: Safety margins adapted for IP receptor potency for the active metabolite were 2-fold (based on total exposure) in relation to human therapeutic exposure.
Slovenian: Varnostna meja za jakost receptorja IP za aktivni presnovek je bila 2-kratna (na podlagi skupne izpostavljenosti) glede na terapevtsko izpostavljenost pri ljudeh.
English: Uncommon side effects (may affect up to 1 in 100 people) - Increased heart rate
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) - zvišan srčni utrip
English: In the presence of food, the exposure to selexipag after a single dose of 400 micrograms was increased by 10% in Caucasian subjects and decreased by 15% in Japanese subjects, whereas exposure to the active metabolite was decreased by 27% (Caucasian subjects) and 12% (Japanese subjects).
Slovenian: V prisotnosti hrane se je izpostavljenost seleksipagu po enkratnem odmerku 400 mikrogramov povečala za 10 % pri belcih in zmanjšala za 15 % pri Japoncih, medtem ko se je izpostavljenost aktivnemu presnovku zmanjšala za 27 % (belci) in 12 % (Japonci).
English: Do not split, crush or chew the tablets.
Slovenian: Tablet ne lomite, drobite in ne žvečite.
English: The effect of strong inhibitors of UGT1A3 and UGT2B7 (valproic acid, probenecid, and fluconazole) on the exposure to selexipag and its active metabolite has not been studied.
Slovenian: Učinka močnih zaviralcev UGT1A3 in UGT2B7 (valprojska kislina, probenecid in flukonazol) na izpostavljenost seleksipagu in njegovemu aktivnemu presnovku niso preučili.
English: Please see section Maintenance dose below for more information.
Slovenian: Za več informacij glejte spodnje poglavje Vzdrževalni odmerek.
English: Starting Treatment With Uptravi
Slovenian: Začetek zdravljenja z zdravilom Uptravi
English: If treatment is missed for 3 days or more, Uptravi should be restarted at a lower dose and then up-titrated.
Slovenian: Če bolnik z zdravljenjem prekine za 3 dni ali več, je treba ponovno uporabo zdravila Uptravi začeti z nižjim odmerkom in ga nato titrirati navzgor.
English: Inducers of CYP2C8
Slovenian: Induktorji CYP2C8
English: Effect of other medicinal products on selexipag
Slovenian: Učinek drugih zdravil na seleksipag
English: Selexipag is a weak substrate of the P-gp efflux pump.
Slovenian: Seleksipag je šibek substrat iztočne črpalke P-gp.
English: If the side effects cannot be treated or do not gradually get better on the dose you are taking, your doctor may adjust your dose by reducing the number of 200 microgram light-yellow tablets you take by one in the morning and by one in the evening.
Slovenian: Če teh neželenih učinkov ni možno zdraviti ali se postopoma ne izboljšajo z odmerkom, ki ga jemljete, se lahko zdravnik odloči, da bo vaš odmerek prilagodil tako, da zmanjša število 200-mikrogramskih svetlo rumenih tablet, ki jih jemljete, za eno manj zjutraj in eno manj zvečer.
English: • The move to the maintenance dose (titration phase);
Slovenian: • koncept odmerjanja in titriranja; • premik na vzdrževalni odmerek (faza titriranja);
English: Electrocardiogram investigations showed sinus tachycardia in 11.3% of patients in the selexipag group compared to 8.8% in the placebo group (see section 5.1).
Slovenian: Preiskave z elektrokardiogramom so pokazale sinusno tahikardijo pri 11,3 % bolnikov v skupini s seleksipagom v primerjavi z 8,8 % v skupini s placebom (glejte poglavje 5.1).
English: There is limited experience with abrupt discontinuation of Uptravi in patients with PAH.
Slovenian: Izkušnje z nenadno prekinitvijo uporabe zdravila Uptravi pri bolnikih s PAH so omejene.
English: Given that the majority of the pharmacological effect is driven by the active metabolite, this effect is not clinically relevant.
Slovenian: Ker je večina farmakoloških učinkov posledica delovanja aktivnega presnovka, ta učinek ni klinično pomemben.
English: The approximate rate of adverse reactions that were serious was 2.3% in the selexipag group and 0.5% in the placebo group.
Slovenian: Približni delež resnih neželenih učinkov je bil 2,3 % v skupini s seleksipagom in 0,5 % v skupini s placebom.
English: Your doctor will instruct you to gradually increase your dose.
Slovenian: Zdravnik vam bo dal navodila za postopno povečevanje vašega odmerka.
English: The mean treatment duration was 76.4 weeks (median 70.7 weeks) for patients receiving selexipag versus 71.2 weeks (median 63.7 weeks) for patients on placebo.
Slovenian: 76,4 tednov (mediana 70,7 tednov) za bolnike, ki so prejemali seleksipag, v primerjavi z 71,2 tedni (mediana 63,7 tednov) za bolnike na placebu.
English: Exercise capacity was evaluated as a secondary endpoint.
Slovenian: Simptomatski opazovani dogodki Zmožnost vadbe so ocenili kot sekundarni opazovani dogodek.
English: Disease progression b n (%)
Slovenian: Napredovanje bolezni b n (%)
English: The most common side effects (may affect more than 1 in 10 people) you may experience while taking Uptravi are:
Slovenian: Najpogostejši neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov), ki se lahko pojavijo med jemanjem zdravila Uptravi so:
English: Selexipag was not teratogenic in rats and rabbits (exposure margins above therapeutic exposure of 13-fold for selexipag and 43-fold for the active metabolite, based on total exposure).
Slovenian: Seleksipag pri podganah in kuncih ni bil not teratogen (meja izpostavljenosti nad terapevtsko izpostavljenostjo 13-kratnik za seleksipag in 43-kratnik za aktivni presnovek, na osnovi skupne izpostavljenosti).
English: The pharmacokinetics of selexipag and its active metabolite have been studied primarily in healthy subjects.
Slovenian: Farmakokinetiko seleksipaga in njegovega aktivnega presnovka so preučili pretežno pri zdravih osebah.
English: There is limited clinical experience in patients over the age of 75 years, therefore Uptravi should be used with caution in this population (see section 4.4).
Slovenian: Klinične izkušnje pri bolnikih, starih več kot 75 let, so omejene, zato je treba zdravilo Uptravi pri tej populaciji uporabljati previdno (glejte poglavje 4.4).
English: In rats, selexipag or its metabolites are excreted in milk (see section 5.3).
Slovenian: Pri podganah se seleksipag ali njegovi presnovki izločajo v mleko (glejte poglavje 5.3).
English: In patients with moderate hepatic impairment, Uptravi should be dosed once daily (see section 4.2).
Slovenian: Pri bolnikih z zmerno okvaro jeter je treba zdravilo Uptravi odmerjati enkrat na dan (glejte poglavje 4.2).
English: • Patient titration guide;
Slovenian: • navodilo za titriranje za bolnika;
English: If you cannot tolerate the side effects even after your doctor or nurse has tried to treat them, he or she may recommend you step down to a lower dose.
Slovenian: Če neželenih učinkov ne morete prenašati, četudi jih zdravnik ali medicinska sestra poskušata zdraviti, vam lahko priporočata znižanje odmerka za en korak.
English: Endpoints & statistics
Slovenian: Opazovane točke in statistika
English: Polyamide / aluminium / HDPE / PE with an embedded desiccant agent / HDPE blister sealed with an aluminium foil.
Slovenian: Poliamid / aluminij / HDPE / PE z dodanim sušilnim sredstvom / HDPE pretisni omot, zatesnjen z aluminijasto folijo.
English: This is one 200 microgram tablet in the morning and another 200 microgram tablet in the evening.
Slovenian: To je ena 200-mikrogramska tableta zjutraj in še ena 200-mikrogramska tableta zvečer.
English: If your doctor instructs you to further increase your dose and move to step 5, this may be done by taking one green 800 microgram tablet and one light-yellow 200 microgram tablet in the morning and one 800 microgram tablet and one 200 microgram tablet in the evening.
Slovenian: Če vam zdravnik naroči, da odmerek še bolj povečate in se premaknete na korak 5, lahko to naredite tako, da vzamete eno zeleno 800-mikrogramsko tableto in eno svetlo rumeno 200-mikrogramsko tableto zjutraj in eno 800-mikrogramsko tableto in eno 200-mikrogramsko tableto zvečer.
English: The mechanisms are rodent-specific.
Slovenian: Mehanizma sta specifična za glodalce.
English: Selexipag is hydrolysed by carboxylesterases to yield its active metabolite, which is approximately 37-fold more potent than selexipag.
Slovenian: Seleksipag se s karboksilesterazami hidrolizira v aktivni presnovek, ki je približno 37-krat bolj močan kot seleksipag.
English: Oxidative metabolism catalysed mainly by CYP2C8 and to a smaller extent by CYP3A4 leads to the formation of hydroxylated and dealkylated products.
Slovenian: Oksidativna presnova, ki jo katalizira predvsem CYP2C8 in v manjši meri CYP3A4, ima za posledico nastanek hidroksiliranih in dealkiliranih snovi.
English: If your side effects are manageable after stepping down your dose, your doctor may decide that you should stay on that dose.
Slovenian: Če so po zmanjšanju odmerka vaši neželeni učinki obvladljivi, se bo morda zdravnik odločil, da naj na tem odmerku ostanete.
English: Since selexipag did not affect the exposure to the CYP3A4 substrates midazolam and R-warfarin or to the CYP2C9 substrate S-warfarin, reduced efficacy of hormonal contraceptives is not expected.
Slovenian: Ker seleksipag ni vplival na izpostavljenost substratoma CYP3A4, midazolamu in R-varfarinu, ali substratu CYP2C9, S-varfarinu, se zmanjšana učinkovitost hormonskih kontraceptivov ne pričakuje.
English: In patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2), caution should be exercised during dose titration.
Slovenian: Pri bolnikih s hudo ledvično okvaro (eGFR < 30 ml/min/1,73 m2) je potrebna previdnost med titriranjem odmerka.
English: The pharmacokinetics of selexipag and the active metabolite, both after single- and multiple-dose administration, were dose-proportional up to a single dose of 800 micrograms and multiple doses of up to 1,800 micrograms twice daily.
Slovenian: Farmakokinetika seleksipaga in aktivnega presnovka, tako pri dajanju enkratnega in večkratnih odmerkov, je bila sorazmerna z odmerkom do enkratnega odmerka 800 mikrogramov in večkratnih odmerkov do 1.800 mikrogramov dvakrat na teden.
English: The first pack of tablets you receive will contain the light-yellow 200 microgram tablets.
Slovenian: Prvo pakiranje tablet, ki ga boste prejeli, bo vsebovalo svetlo rumene 200-mikrogramske tablete.
English: By mimicking the action of prostacyclin, Uptravi widens the pulmonary arteries and reduces their hardening.
Slovenian: S posnemanjem delovanja prostaciklina zdravilo Uptravi pljučne arterije razširi in zmanjša njihovo trdost.
English: Uptravi has minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Uptravi ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: • Cover letter to the healthcare professional;
Slovenian: • spremni dopis za zdravstvenega delavca
English: The finding did not occur in mouse or rat toxicity studies.
Slovenian: Izsledka niso zasledili v študijah toksičnosti pri miših ali podganah.
English: 23% of patients on selexipag achieved maintenance doses in the range of 200-400 micrograms, 31% achieved doses in the range of 600-1,000 micrograms, and 43% achieved doses in the range of 1,200-1,600 micrograms.
Slovenian: 23 % bolnikov na seleksipagu je doseglo vzdrževalni odmerek v razponu 200-400 mikrogramov, 31 % jih je doseglo odmerke v razponu od 600-1.000 mikrogramov in 43 % jih je doseglo odmerke v razponu 1.200-1.600 mikrogramov.
English: Some patients may have 200 micrograms in the morning and in the evening as their maintenance dose, while some will reach the highest dose of 1,600 micrograms in the morning and in the evening.
Slovenian: Nekaterim bolnikom zadošča 200 mikrogramov zjutraj in zvečer kot vzdrževalni odmerek, drugi pa dosežejo največji odmerek 1.600 mikrogramov zjutraj in zvečer.
English: If you experience any of these side effects: headache, diarrhoea, feeling sick (nausea), being sick (vomiting), jaw pain, muscle pain, leg pain, joint pain, or reddening of the face, that you cannot tolerate or that cannot be treated, you should contact your doctor as the dose you are taking maybe too high for you and may need to be reduced.
Slovenian: Če se pojavijo kateri od naslednjih neželenih učinkov: glavobol, driska, občutek siljenja na bruhanje (navzea), bruhanje, bolečine v čeljustih, bolečine v mišicah, bolečine v nogah, bolečine v sklepih ali rdečina obraza, ki jih ne morete prenašati ali ki jih ni možno zdraviti, se posvetujte z zdravnikom, saj je morda odmerek prevelik in ga bo treba zmanjšati.
English: In adult and juvenile dogs, intestine and bone / bone marrow were identified as the main target organs after treatment with selexipag.
Slovenian: Pri odraslih psih in mladih psih so kot glavne ciljne organe po zdravljenju s seleksipagom opredelili črevesje in kosti/kostni mozeg.
English: Selectivity against EP1, EP3, FP, and TP is important because these are well-described contractile receptors in the gastro-intestinal tract and blood vessels.
Slovenian: Selektivnost proti EP1, EP3, FP in TP je pomembna, saj so to dobro opisani kontraktilni receptorji v prebavilih in žilah.
English: Before prescribing Uptravi, physicians should carefully consider whether patients with certain underlying conditions could be adversely affected by vasodilatory effects (e.g., patients on antihypertensive therapy or with resting hypotension, hypovolaemia, severe left ventricular outflow obstruction or autonomic dysfunction).
Slovenian: Preden zdravnik zdravilo Uptravi predpiše, mora skrbno oceniti, ali lahko vazodilatorni učinki vplivajo na nekatere obstoječe bolezni bolnika (npr. bolniki na antihipertenzivnem zdravljenju ali z hipotenzijo med mirovanjem, hipovolemijo, hudo obstrukcijo iztočnega dela levega prekata ali avtonomno disfunkcijo).
English: Selexipag and its main metabolite showed 20- to 80-times lower prostacyclin (IP) receptor potency in vitro for animal species used in reproductive toxicity testing compared to humans.
Slovenian: In vitro se je pokazalo, da imata seleksipag in njegov glavni presnovek 20- do 80-krat manjšo jakost vezave na prostaciklinski receptor (IP) za živalske vrste, uporabljene v študijah vpliva na sposobnost razmnoževanja, v primerjavi z ljudmi.
English: In rat studies, selexipag at high doses caused transient disturbances in oestrus cycles that did not affect fertility (see section 5.3).
Slovenian: V študijah s podganami je seleksipag pri velikih odmerkih povzročil prehodne motnje estrusnih ciklov, ki niso vplivali na plodnost (glejte poglavje 5.3).
English: What is important is that you reach the dose that is most appropriate to treat you.
Slovenian: Pomembno je, da dosežete odmerek, ki je najprimernejši za vaše zdravljenje.
English: Over time, your doctor may adjust your maintenance dose as needed.
Slovenian: Sčasoma vam lahko zdravnik vaš vzdrževalni odmerek prilagodi, kot je potrebno.
English: Suddenly stopping your treatment with Uptravi might lead to your symptoms getting worse.
Slovenian: Če ste prenehali jemati zdravilo Uptravi Če zdravljenje z zdravilom Uptravi nenadno prekinete, se lahko vaši simptomi poslabšajo.
English: Prostanoid initiation or oxygen therapy b c n (%)
Slovenian: uvedba prostanoida ali kisikova terapijab c n (%)
English: Selexipag does not cause IP receptor desensitisation in vitro nor tachyphylaxis in a rat model.
Slovenian: Seleksipag ne povzroča desenzibilizacije receptorjev IP in vitro ali tahifilaksije v podganjem modelu.
English: Do this only if instructed to do so by your doctor.
Slovenian: To storite le po navodilu zdravnika.
English: It lets your body adjust to the new medicine.
Slovenian: Telesu omogoča, da se navaja na novo zdravilo.
English: On the diary pages, check off that you have taken one 800 microgram tablet every day in the morning and in the evening with your prescribed number of 200 microgram tablets.
Slovenian: Na straneh dnevnika odkljukajte, da ste vsak dan vzeli eno 800-mikrogramsko tableto zjutraj in zvečer, vključno s predpisanim številom 200-mikrogramskih tablet.
English: For example, if your highest tolerated dose during titration was 1,200 micrograms once in the morning and once in the evening:
Slovenian: Če je bil na primer največji odmerek, ki ste ga prenašali med titriranjem, 1.200 mikrogramov enkrat zjutraj in enkrat zvečer:
English: This dose will be your maintenance dose.
Slovenian: To bo vaš vzdrževalni odmerek.
English: Selexipag is a selective IP receptor agonist distinct from prostacyclin and its analogues.
Slovenian: Seleksipag je selektivni agonist receptorjev IP, ki se razlikuje od prostaciklina in njegovih analogov.
English: The safety of selexipag has been evaluated in a long-term, Phase 3 placebo-controlled study enrolling 1,156 patients with symptomatic PAH.
Slovenian: Varnost seleksipaga so ocenili v dolgoročni študiji faze 3, nadzorovane s placebom, v katero je bilo vključenih 1.156 bolnikov s simptomatsko PAH.
English: 10 film-coated tablets 60 film-coated tablets
Slovenian: 10 filmsko obloženih tablet 60 filmsko obloženih tablet
English: The total number of deaths of all causes up to study closure was 100 (17.4%) for the selexipag group and 105 (18.0%) for the placebo group (HR 0.97, 99% CI: 0.68, 1.39).
Slovenian: Skupno število smrti zaradi vseh razlogov do zaprtja študije je bilo 100 (17,4 %) za skupino s seleksipagom in 105 (18,0 %) za skupino s placebom (RT 0,97, 99-% IZ: 0,68; 1,39).
English: Because of the species-specific sensitivity of dogs to develop intussusception, this finding is considered not relevant for adult humans.
Slovenian: specifične za vrsto, za razvoj invaginacije, ta izsledek ni pomemben za odrasle ljudi.
English: 60 or 140 film-coated tablets Titration pack
Slovenian: 60 ali 140 filmsko obloženih tablet titracijsko pakiranje
English: Over time, your doctor or nurse may adjust your maintenance dose as needed.
Slovenian: Sčasoma vam lahko zdravnik ali medicinska sestra vaš vzdrževalni odmerek prilagodita, kot je potrebno.
English: The effect of selexipag on progression of PAH was demonstrated in a multi-centre, long-term (maximum duration of exposure approximately 4.2 years), double-blind, placebo-controlled, parallel-group, event-driven Phase 3 study in 1,156 patients with symptomatic (WHO FC I-IV) PAH.
Slovenian: Učinek seleksipaga na napredovanje PAH so dokazali v multicentrični, dolgotrajni (največje trajanje izpostavljenosti približno 4,2 leti), dvojno slepi, s placebom nadzorovani, študiji faze 3 z vzporednimi skupinami, odvisni od dogodkov, s 1.156 bolniki s simptomatsko PAH (FR I-IV po SZO).
English: Exposure to the active metabolite remained almost unchanged in subjects with mild hepatic impairment and was doubled in subjects with moderate hepatic impairment.
Slovenian: Izpostavljenost aktivnemu presnovku je ostala skoraj nespremenjena pri osebah z blago okvaro jeter, pri osebah z zmerno okvaro jeter pa se je podvojila.
English: There is no experience with Uptravi in patients undergoing dialysis (see section 5.2), therefore Uptravi should not be used in these patients.
Slovenian: Izkušenj z zdravilom Uptravi pri bolnikih, ki se zdravijo z dializo, ni (glejte poglavje 5.2), zato se zdravila Uptravi tem bolnikom ne sme dajati.
English: In healthy subjects, inter-subject variability in exposure (area under the curve over a dosing interval) at steady state was 43% and 39% for selexipag and the active metabolite, respectively.
Slovenian: Pri zdravih osebah je bila variabilnost izpostavljenosti med posamezniki (površina pod krivuljo med intervalom odmerjanja) v stanju dinamičnega ravnovesja 43 % za seleksipag in 39 % za aktivni presnovek.
English: In a Phase 3 placebo-controlled study in patients with PAH, mean absolute changes in haemoglobin at regular visits compared to baseline ranged from −0.34 to −0.02 g/dL in the selexipag group compared to −0.05 to 0.25 g/dL in the placebo group.
Slovenian: V študiji faze 3, nadzorovani s placebom, pri bolnikih s PAH, je bil povprečni razpon absolutnih sprememb v hemoglobinu ob rednih obiskih v primerjavi z izhodiščem od −0,34 do −0,02 g/dl v skupini s seleksipagom v primerjavi z −0,05 do 0,25 g/dl v skupini s placebom.
English: This allows you to take one tablet in the morning and one in the evening, instead of multiple tablets each time.
Slovenian: Tako boste lahko zjutraj in zvečer vzeli le eno tableto, namesto vsakič več tablet.
English: Stimulation of the IP receptor by selexipag and the active metabolite leads to vasodilatory as well as anti-proliferative and anti-fibrotic effects.
Slovenian: Stimulacija receptorjev IP, ki jo izvajata seleksipag in aktivni presnovek, povzroči vazodilatacijske, antiproliferativne in antifibrotične učinke.
English: Patients who have poor vision or are blind must be instructed to get assistance from another person when taking Uptravi during the titration period.
Slovenian: Bolnikom, ki slabo vidijo ali so slepi, je treba naročiti, da naj jim v obdobju titriranja odmerka zdravila
English: • Cerebrovascular events (e.g., transient ischaemic attack, stroke) within the last 3 months.
Slovenian: • Cerebrovaskularni dogodki (npr. tranzitorna ishemična ataka, možganska kap) v zadnjih
English: The percentages of patients with an event at Month 36 were 28.9% and 41.3% in the selexipag and placebo groups, respectively, with an absolute risk reduction of 12.4%.
Slovenian: Odstotek bolnikov z dogodkom v 36. mesecu je bil 28,9 % za skupino s seleksipagom in 41,3 % za skupino s placebom z absolutnim zmanjšanjem tveganja za
English: In the rat pre-/post-natal development study, selexipag induced no effects on maternal and pup reproductive function.
Slovenian: V študijah pred- in postnatalnega razvoja pri podganah seleksipag ni izzval učinkov na sposobnost razmnoževanja samice in mladičev.