FrancophonIA/ELRC3.0 huggingface dataset:
English: The healthcare professional A4 laminated titration guide is intended to reduce the risk of medication error due to the titration phase at treatment initiation with Uptravi and it should contain the following key elements:
Croatian: Vodič za titraciju doze za zdravstvenog radnika na plastificiranom kartonu A4 formata namijenjen je smanjenju rizika od medikacijske pogreške tijekom faze titracije i početka liječenja Uptravijem i treba sadržavati sljedeće ključne elemente:
English: Women of childbearing potential should practise effective contraception while taking selexipag.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom uzimanja seleksipaga.
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.
Croatian: Nisu uočeni klinički značajni učinci spola, rase, dobi ili tjelesne težine na farmakokinetiku seleksipaga i njegovog aktivnog metabolita u zdravih ispitanika niti u bolesnika s PAH-om.
English: Selexipag and its active metabolite are substrates of OATP1B1 and OATP1B3.
Croatian: Seleksipag i njegov aktivni metabolit su supstrati za OATP1B1 i OATP1B3.
English: Selexipag and its active metabolite do not inhibit or induce cytochrome P450 enzymes and transport proteins at clinically relevant concentrations.
Croatian: Utjecaj seleksipaga na druge lijekove Seleksipag i njegov aktivni metabolit ne inhibiraju i ne induciraju enzime citokroma P450 i transportne proteine pri klinički značajnim koncentracijama.
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.
Croatian: Budući da seleksipag nije utjecao na izloženost supstratima za CYP3A4, midazolamu i R-varfarinu, ni supstratu za CYP2C9, S-varfarinu, ne očekuje se smanjena djelotvornost hormonskih kontraceptiva.
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.
Croatian: Farmakokinetika seleksipaga i aktivnog metabolita je i nakon jednokratne i nakon višekratne primjene doze bila proporcionalna dozi, sve do jednokratne doze od 800 mikrograma i višekratnih doza do 1800 mikrograma dva puta dnevno.
English: Coagulation factors
Croatian: Faktori zgrušavanja
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.
Croatian: Utjecaj jakih inhibitora UGT1A3 i UGT2B7 (valproatne kiseline, probenecida, i flukonazola) na izloženost seleksipagu i njegovom aktivnom metabolitu nije ispitivan.
English: Selexipag is hydrolysed by carboxylesterases to yield its active metabolite, which is approximately 37-fold more potent than selexipag.
Croatian: Seleksipag hidroliziraju karboksilesteraze čime nastaje njegov aktivni metabolit koji je približno 37 puta potentniji od seleksipaga.
English: Titration
Croatian: Titracija
English: The pharmacokinetics of selexipag and its active metabolite have been studied primarily in healthy subjects.
Croatian: Farmakokinetika seleksipaga i njegovog aktivnog metabolita uglavnom je ispitivana na zdravim ispitanicima.
English: Inhibitors of UGT1A3 and UGT2B7
Croatian: Inhibitori UGT1A3 i UGT2B7
English: The doctor may then prescribe you a lower single-tablet strength.
Croatian: Liječnik Vam tada može propisati manju jačinu u jednoj tableti.
English: Uptravi 200 microgram
Croatian: Uptravi 200 mikrograma
English: Death up to study closure d n (%)
Croatian: Smrt do završetka ispitivanja d n (%)
English: In a study in healthy subjects, selexipag (400 micrograms twice daily) did not alter the exposure to S-warfarin (CYP2C9 substrate) or R-warfarin (CYP3A4 substrate) after a single dose of 20 mg warfarin.
Croatian: U ispitivanju na zdravim ispitanicima seleksipag (400 mikrograma dva puta dnevno) nije promijenio izloženost S-varfarinu (supstrat za CYP2C9) ili R-varfarinu (supstrat za CYP3A4) nakon jednokratne doze od 20 mg varfarina.
English: In patients with moderate hepatic impairment, Uptravi should be dosed once daily (see section 4.2).
Croatian: U bolesnika s umjerenim oštećenjem funkcije jetre, Uptravi treba primjenjivati jednom dnevno (vidjeti dio 4.2).
English: Anticoagulants or inhibitors of platelet aggregation
Croatian: Antikoagulansi ili inhibitori agregacije trombocita
English: The overall median double-blind treatment duration was 63.7 weeks for the placebo group and 70.7 weeks for the selexipag group.
Croatian: Medijan ukupnog trajanja dvostruko slijepog liječenja bio je 63,7 tjedana za skupinu koja je primala placebo i 70,7 tjedana za skupinu koja je primala seleksipag.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Uptravi Lijek čuvajte izvan pogleda i dohvata djece.
English: Oxidative metabolism catalysed mainly by CYP2C8 and to a smaller extent by CYP3A4 leads to the formation of hydroxylated and dealkylated products.
Croatian: Oksidativni metabolizam uglavnom kataliziran enzimom CYP2C8 i u manjoj mjeri CYP3A4 dovodi do nastanka hidroksiliranih i dealkiliranih produkata.
English: The first intake of the increased dose should be in the evening.
Croatian: Prvo uzimanje povećane doze treba biti navečer.
English: The safety of selexipag has been evaluated in a long-term, Phase 3 placebo-controlled study enrolling 1,156 patients with symptomatic PAH.
Croatian: Sigurnost seleksipaga procijenjena je u dugoročnom, placebom kontroliranom ispitivanju faze 3 koje je obuhvatilo 1156 bolesnika sa simptomatskim PAH-om.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti, nuspojave su navedene redom od ozbiljnijih prema manje ozbiljnima.
English: Dose adjustment of selexipag may be required with concomitant administration of inducers of CYP2C8 (e.g., rifampicin, carbamazepine, phenytoin).
Croatian: Može biti potrebna prilagodba doze seleksipaga uz istodobnu primjenu induktora CYP2C8 (npr. rifampicin, karbamazepin, fenitoin).
English: Quality of life was assessed in a subset of patients in the GRIPHON study using the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) questionnaire.
Croatian: Kvaliteta života procijenjena je na podskupini bolesnika u ispitivanju GRIPHON uz pomoć upitnika CAMPHOR (od engl.
English: If you forget to take Uptravi
Croatian: Ako zaboravite uzeti Uptravi
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - TITRATION PACK
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA - PAKIRANJE ZA TITRACIJU DOZE
English: Use pages 20 to 27 to track the first weeks of treatment, when you are using 200 microgram tablets only (steps 1-4).
Croatian: Koristite stranice 20 do 27 za praćenje prvih tjedana liječenja, dok uzimate samo tablete od
English: The exposure to the active metabolite at steady state in these patients during a once-daily regimen is predicted to be similar to that in healthy subjects during a twice-daily regimen.
Croatian: Predviđa se da će izloženost aktivnom metabolitu u stanju dinamičke ravnoteže u ovih bolesnika tijekom režima doziranja jednom dnevno biti slična onoj u zdravih ispitanika tijekom režima doziranja dva puta dnevno.
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%.
Croatian: Postotak bolesnika s događajem u 36. mjesecu bio je 28,9% u skupini koja je primala seleksipag i 41,3% u skupini koja je primala placebo, s apsolutnim smanjenjem rizika od 12,4%.
English: Cardiac electrophysiology
Croatian: Farmakodinamički učinci Elektrofiziologija srca
English: Selexipag is an inhibitor of platelet aggregation in vitro.
Croatian: Seleksipag je inhibitor agregacije trombocita in vitro.
English: The primary study endpoint was the time to first occurrence of a morbidity or mortality event up to end of treatment, defined as a composite of death (all causes); or hospitalisation for PAH; or progression of PAH resulting in need for lung transplantation or balloon atrial septostomy; or initiation of parenteral prostanoid therapy or chronic oxygen therapy; or other disease-progression events (patients in WHO FC II or III at baseline) confirmed by a decrease in 6-minute walk distance (6MWD) from baseline (≥ 15%) and worsening of WHO FC or (patients in WHO FC III or IV at baseline) confirmed by a decrease in 6MWD from baseline (≥ 15%) and need for additional
Croatian: Primarna mjera ishoda ispitivanja bila je vrijeme do prve pojave događaja morbiditeta ili mortaliteta do završetka liječenja, definirano kao kompozitna točka koja obuhvaća smrt (svih uzroka); ili hospitalizaciju zbog PAH-a; ili progresiju PAH-a s posljedicom potrebe za transplantacijom pluća ili atrijskom septostomijom pomoću balona; ili uvođenje parenteralnog liječenja prostanoidima ili dugotrajno liječenje kisikom; ili druge događaje koji označavaju progresiju bolesti (bolesnici s WHO FC II ili III na početku) potvrđene smanjenjem udaljenosti u 6-minutnom testu hodanja (6MTH) od početne vrijednosti (≥ 15%) i pogoršanje WHO FC ili (bolesnici s WHO FC III ili IV na početku) potvrđeno smanjenjem udaljenosti u 6MTH od početne vrijednosti (≥ 15%) i potrebom za dodatnim lijekovima za PAH.
English: • Cerebrovascular events (e.g., transient ischaemic attack, stroke) within the last 3 months.
Croatian: • Cerebrovaskularni događaji (npr. tranzitorna ishemična ataka, moždani udar) unutar zadnja
English: The first pack of tablets you receive will contain the light-yellow 200 microgram tablets.
Croatian: Prvo pakiranje tableta koje primite sadržavat će svijetlo žute tablete od 200 mikrograma.
English: Remember to talk to your PAH doctor or nurse regularly.
Croatian: Sjetite se redovito razgovarati sa svojim liječnikom za PAH ili medicinskom sestrom.
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.
Croatian: Ako Vas liječnik uputi na daljnje povećanje doze i prijeđete na 5. korak, to možete učiniti uzimanjem jedne zelene tablete od 800 mikrograma i jedne svijetlo žute tablete od 200 mikrograma ujutro te jedne tablete od 800 mikrograma i jedne tablete od 200 mikrograma navečer.
English: If your doctor or nurse tells you to step down to a lower dose, you should take one less 200 microgram tablet in the morning and one less in the evening.
Croatian: Ako Vam Vaš liječnik ili medicinska sestra kaže da si smanjite dozu, trebate uzeti jednu tabletu od 200 mikrograma manje ujutro i jednu tabletu manje navečer.
English: • The move to the maintenance dose (titration phase);
Croatian: • Koncept doziranja i titracije doze; • Korake do doze održavanja (faza titracije);
English: Starting Treatment With Uptravi
Croatian: Početak liječenja Uptravijem
English: The efficacy of selexipag on the primary endpoint was consistent across subgroups of age, sex, race, aetiology, geographical region, WHO FC, and as monotherapy or in combination with an ERA or a PDE-5 inhibitor or triple combination with both an ERA and a PDE-5 inhibitor.
Croatian: Djelotvornost seleksipaga u pogledu primarne mjere ishoda bila je dosljedna u svim podskupinama s obzirom na dob, spol, rasu, etiologiju, geografsko područje, WHO FC stupanj te na primjenu u monoterapiji ili u kombinaciji s ERA-om ili inhibitorom PDE-5 ili u trostrukoj kombinaciji s ERA-om i inhibitorom PDE-5.
English: If, for any reason, you stop taking Uptravi for more than 3 consecutive days (if you missed 3 morning and 3 evening doses, or 6 doses in a row or more), contact your doctor immediately as your dose may need to be adjusted to avoid side effects.
Croatian: Ako, iz bilo kojeg razloga, prestanete uzimati Uptravi tijekom više od 3 uzastopna dana (ako propustite 3 jutarnje i 3 večernje doze ili 6 doza zaredom ili više), odmah se javite svom liječniku jer
English: In patients without concurrent PAH-specific therapy, the placebo-corrected treatment effect measured at trough was 34 m (99% CI: 10, 63 m).
Croatian: U bolesnika koji nisu istovremeno uzimali lijekove za PAH, učinak liječenja korigiran u odnosu na placebo mjeren na kraju doznog intervala bio je 34 m (99% CI: 10, 63 m).
English: 10 film-coated tablets 60 film-coated tablets
Croatian: 10 filmom obloženih tableta 60 filmom obloženih tableta
English: Selexipag and its active metabolite both undergo oxidative metabolism mainly by CYP2C8 and to a smaller extent by CYP3A4.
Croatian: I seleksipag i njegov aktivni metabolit prolaze oksidativni metabolizam uglavnom putem CYP2C8 i manje putem CYP3A4.
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.
Croatian: 76,4 tjedna (medijan 70,7 tjedana) za bolesnike koji su primali seleksipag, naspram 71,2 tjedna (medijan 63,7 tjedana) za bolesnike koji su primali placebo.
English: In the tablet core:
Croatian: U jezgri tablete:
English: Your doctor will prescribe a suitable tablet strength for your maintenance dose.
Croatian: Vaš će Vam liječnik propisati odgovarajuću jačinu tableta za dozu održavanja.
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.
Croatian: Utjecaj seleksipaga na progresiju PAH-a pokazan je u multicentričnom, dugoročnom (najdulje trajanje izloženosti približno 4,2 godine), dvostruko slijepom, placebom kontroliranom, događajima oblikovanom, ispitivanju paralelnih skupina faze 3 u 1156 bolesnika sa simptomatskim (WHO FC IIV) PAH-om.
English: Uptravi should not be administered in patients with severe liver impairment (Child-Pugh class C; see section 4.4).
Croatian: Uptravi se ne bi trebao primjenjivati u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh stadij C; vidjeti dio 4.4).
English: • The distribution of kits to all identified prescribers to minimise the risks of medication error in particular;
Croatian: • Sastavljanje i održavanje popisa svih propisivača Uptravija; • Distribucija Kompleta svim identificiranim propisivačima kako bi se smanjili rizici, osobito od medikacijske pogreške;
English: Uncommon (≥ 1/1,000 to < 1/100)
Croatian: (≥ 1/1000 i < 1/100)
English: A Phase 2 double-blind, placebo-controlled clinical study assessed haemodynamic variables after 17 weeks of treatment in patients with PAH WHO FC II-III and concomitantly receiving ERAs and/or PDE-5 inhibitors.
Croatian: Dvostruko slijepo placebom kontrolirano kliničko ispitivanje faze 2 procijenilo je hemodinamske varijable nakon 17 tjedana liječenja u bolesnika s PAH-om WHO FC II-III koji su istovremeno primali ERA-e i/ili inhibitore PDE-5.
English: A decrease from baseline in haemoglobin concentration to below 10 g/dL was reported in 8.6% of selexipag-treated patients and 5.0% of placebo-treated patients.
Croatian: Pad koncentracije hemoglobina u odnosu na početne vrijednosti na ispod 10 g/dl prijavljen je u 8,6% bolesnika liječenih seleksipagom i u 5,0% bolesnika liječenih placebom.
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.
Croatian: U zdravih ispitanika, varijabilnost izloženosti između pojedinih bolesnika (površina ispod krivulje tijekom doznog intervala) u stanju dinamičke ravnoteže bila je 43% za seleksipag i 39% za aktivni metabolit.
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.
Croatian: 23% bolesnika koji su primali seleksipag postiglo je doze održavanja u rasponu 200-400 mikrograma, 31% postiglo je doze u rasponu 600-1000 mikrograma, a 43% postiglo je doze u rasponu 1200-1600 mikrograma.
English: The maximum dose of Uptravi is 1,600 micrograms in the morning and 1,600 micrograms in the evening.
Croatian: Najveća doza Uptravija je 1600 mikrograma ujutro i 1600 mikrograma navečer.
English: In the repeated-dose toxicity studies in rodents, strong blood pressure decrease as a result of exaggerated pharmacology induced transient clinical signs and reduced food consumption and body-weight gain.
Croatian: U ispitivanjima toksičnosti ponovljenih doza na glodavcima, jak pad krvnog tlaka kao posljedica pretjerane reakcije na lijek uzrokovao je pojavu prolaznih kliničkih znakova te smanjeno uzimanje hrane i dobivanje na tjelesnoj težini.
English: Given the 37-fold higher potency of the active metabolite, this effect is not clinically relevant.
Croatian: S obzirom da je aktivni metabolit 37 puta potentniji, ovaj učinak nije klinički značajan.
English: No evidence for acute rebound has been observed.
Croatian: Nisu uočeni dokazi akutnog povratnog pogoršanja (engl. rebound).
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).
Croatian: Uptravija liječnici trebaju pažljivo razmotriti mogu li se u bolesnika s podležećim stanjima javiti nuspojave zbog vazodilatacijskog učinka (npr. bolesnici na antihipertenzivnoj terapiji ili s hipotenzijom u mirovanju, hipovolemijom, teškom opstrukcijom istjecanja krvi iz lijevog ventrikula ili autonomnom disfunkcijom).
English: UGT1A3 and UGT2B7 are involved in the glucuronidation of the active metabolite.
Croatian: UGT1A3 i UGT2B7 sudjeluju u glukuronidaciji aktivnog metabolita.
English: The goal is to reach the dose that is most appropriate to treat you.
Croatian: Cilj je dosegnuti dozu koja Vama najbolje odgovara za liječenje.
English: In the Phase 3 placebo-controlled trial in patients with PAH, the use of selexipag in combination with both an ERA and a PDE-5 inhibitor resulted in a 30% lower exposure to the active metabolite.
Croatian: U placebom kontroliranom ispitivanju faze 3 u bolesnika s PAH-om, primjena seleksipaga u kombinaciji s ERA-om i inhibitorom PDE-5 imala je za posljedicu 30% nižu izloženost aktivnom metabolitu.
English: • Diary to facilitate Uptravi use and serve as a reminder for the patients (e.g., to contact her/his doctor), and a place to record intake of tablets;
Croatian: • Dnevnik koji olakšava primjenu Uptravija, služi kao podsjetnik za bolesnike (npr. da se jave svom liječniku) i mjesto gdje mogu zabilježiti uzimanje tableta; • Informacije o sigurnoj i djelotvornoj primjeni Uptravija pisane laičkim jezikom.
English: Exposure to selexipag and its active metabolite in these two subjects was similar to that in subjects with moderate (Child-Pugh class B) hepatic impairment.
Croatian: Izloženost seleksipagu i njegovom aktivnom metabolitu u ta dva ispitanika bila je slična onoj u ispitanika s umjerenim (Child-Pugh stadij B) oštećenjem funkcije jetre.
English: Selexipag is hydrolysed to its active metabolite by carboxylesterases (see section 5.2).
Croatian: Seleksipag se hidrolizira u svoj aktivni metabolit karboksilesterazama (vidjeti dio 5.2).
English: The highest tolerated dose reached during dose titration should be maintained.
Croatian: Potrebno je održavati najveću dozu dosegnutu tijekom titracije koja se može podnositi.
English: When co-administered with moderate CYP2C8 inhibitors (e.g., clopidogrel, deferasirox and teriflunomide), reduce the dosing of Uptravi to once daily.
Croatian: Kada se primjenjuje istodobno s umjerenim inhibitorima CYP2C8 (npr. klopidogrelom, deferasiroksom i teriflunomidom), smanjite doziranje lijeka Uptravi na jednom dnevno.
English: Dialysis is unlikely to be effective because selexipag and its active metabolite are highly protein bound.
Croatian: Nije vjerojatna djelotvornost dijalize zbog znatnog vezanja seleksipaga i njegovog aktivnog metabolita za proteine plazme.
English: How to take Uptravi
Croatian: Kako uzimati Uptravi
English: A potential pharmacokinetic interaction with strong inhibitors of UGT1A3 and UGT2B7 cannot be excluded.
Croatian: Moguća farmakokinetička interakcija s jakim inhibitorima UGT1A3 i UGT2B7 ne može se isključiti.
English: In the film coat:
Croatian: U film ovojnici:
English: If you have poor vision or experience any type of blindness, get help from another person when taking Uptravi during the titration period.
Croatian: Ako slabo vidite ili patite od bilo koje vrste sljepoće, zatražite pomoć od druge osobe pri uzimanju
English: In clinical practice, gastro-intestinal events have been observed to respond to anti-diarrhoeal, anti-emetic, and anti-nauseant medicinal products and/or medicinal products for functional gastro-intestinal disorders.
Croatian: U kliničkoj praksi se pokazalo da nuspojave u probavnom sustavu odgovaraju na antidijaroike, antiemetike te lijekove protiv mučnine i/ili lijekove za funkcionalne poremećaje probavnog sustava.
English: - if you have a heart problem, such as: poor blood flow to the heart muscles (severe coronary heart disease or unstable angina); symptoms can include chest pain heart attack within the last 6 months weak heart (decompensated cardiac failure) that is not under close medical observation severe irregular heartbeat defect of the heart valves (inborn or acquired) that causes the heart to work poorly (not related to pulmonary hypertension) - if you have had a stroke within the last 3 months, or any other occurrence that reduced the blood supply to the brain (e.g., transient ischaemic attack) - if you are taking gemfibrozil (medicine used to lower the level of fats [lipids] in the blood)
Croatian: slab protok krvi kroz srčani mišić (teška koronarna bolest srca ili nestabilna angina); simptomi mogu uključivati bolove u prsnom košu srčani udar unutar zadnjih 6 mjeseci slabo srce (dekompenzirano zatajenje srca) koje nije pod strogim medicinskim nadzorom teške nepravilnosti srčanog ritma oštećenje srčanih zalistaka (urođeno ili stečeno) koje uzrokuje slab rad srca (nevezano uz plućnu hipertenziju) - ako ste unutar protekla 3 mjeseca imali moždani udar ili bilo koji drugi događaj koji je doveo do smanjene oskrbe mozga krvlju (npr. tranzitornu ishemijsku ataku).
English: This lets you take just one tablet in the morning and one in the evening, instead of multiple tablets for each dose.
Croatian: To Vam omogućuje da uzimate samo jednu tabletu ujutro i jednu navečer, umjesto da svaki put uzimate više tableta.
English: • Concomitant use of strong inhibitors of CYP2C8 (e.g., gemfibrozil; see section 4.5).
Croatian: • Istodobna primjena jakih inhibitora CYP2C8 (npr. gemfibrozil, vidjeti dio 4.5).
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).
Croatian: Ukupan broj smrtnih slučajeva svih uzroka do završetka ispitivanja bio je 100 (17,4%) u skupini koja je primala seleksipag i 105 (18,0%) u skupini koja je primala placebo (HR 0,97; 99% CI: 0,68; 1,39).
English: Adverse reactions obtained from the pivotal clinical study are tabulated below.
Croatian: Nuspojave zabilježene u pivotalnom kliničkom ispitivanju prikazane su u tablici ispod.
English: There is limited experience with Uptravi in patients older than 75 years.
Croatian: U bolesnika starijih od 75 godina iskustvo s Uptravijem je ograničeno.
English: ↓When should you step down?
Croatian: ↓Kada trebate smanjiti dozu?
English: The starting dose for Uptravi is 200 micrograms once in the morning and once in the evening.
Croatian: Početna doza Uptravija je 200 mikrograma jednom ujutro i jednom navečer.