FrancophonIA/ELRC3.0 huggingface dataset:
English: Elimination of selexipag is predominantly via metabolism with a mean terminal half-life of 0.8-2.5 h. The active metabolite has a half-life of 6.2-13.5 h. The total body clearance of selexipag is 17.9 L/h.
Slovenian: Seleksipag se pretežno izloča s presnovo in ima povprečen končni razpolovni čas 0,8-2,5 h. Aktivni presnovek ima razpolovni čas 6,2-13,5 h. Skupni očistek seleksipaga iz telesa je 17,9 l/h.
English: The dose is increased in increments of 200 micrograms given twice daily, usually at weekly intervals.
Slovenian: Odmerek se postopoma veča po 200 mikrogramov dvakrat na dan, običajno v tedenskih intervalih.
English: Diarrhoea* Vomiting * Nausea*
Slovenian: Bolezni prebavil driska* bruhanje* navzea*
English: The maximum dose of Uptravi is 1,600 micrograms in the morning and 1,600 micrograms in the evening.
Slovenian: Največji odmerek zdravila Uptravi je 1.600 mikrogramov zjutraj in 1.600 mikrogramov zvečer.
English: Excretion in healthy subjects was complete 5 days after administration and occurred primarily via faeces (accounting for 93% of the administered dose) compared to 12% in urine.
Slovenian: Izločanje pri zdravih osebah je bilo končano 5 dni po dajanju, potekalo pa je pretežno z blatom (tako se je izločilo 93 % danega odmerka), 12 % pa se je izločilo z urinom.
English: This will be the highest dose you can tolerate, which may reach the maximum dose of 1,600 micrograms in the morning and in the evening.
Slovenian: To bo največji odmerek, ki ga lahko prenašate, in je lahko največ 1.600 mikrogramov zjutraj in zvečer.
English: Read the package leaflet and titration guide before use.
Slovenian: Pred uporabo preberite priloženo navodilo in navodilo za titriranje!
English: Concomitant administration of selexipag with CYP3A4 substrates does not require dose adjustment.
Slovenian: Pri sočasnem dajanju seleksipaga in substratov CYP3A4 prilagoditev odmerka ni potrebna.
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.
Slovenian: V preskušanjih faze 3, nadzorovanih s placebom, pri bolnikih s PAH, je uporaba seleksipaga v kombinaciji z enim od zaviralcev ERA in zaviralcem PDE-5 povzročila 30-% nižjo izpostavljenost aktivnemu presnovku.
English: If your doctor instructs you to prolong each titration step longer than 1 week, there are additional diary pages to allow you to track this.
Slovenian: Če vam zdravnik naroči, da vsak korak titracije podaljšate na več kot 1 teden, lahko to beležite na dodatne strani v dnevniku.
English: At baseline, the majority of enrolled patients (80%) were being treated with a stable dose of a specific therapy for PAH, either an ERA (15%) or a PDE-5 inhibitor (32%) or both an ERA and a PDE-5 inhibitor (33%).
Slovenian: Ob izhodišču se je večina vključenih bolnikov (80 %) zdravila s stabilnim odmerkom specifičnega zdravila za PAH, bodisi z ERA (15 %) ali z zaviralcem PDE-5 (32 %) ali z ERA in zaviralcem PDE-5
English: In patients in whom up-titration was limited by reasons other than adverse reactions reflecting the mode of action of Uptravi, a second attempt to continue up-titration to the highest individually tolerated dose up to a maximum dose of 1,600 micrograms twice daily may be considered.
Slovenian: Pri bolnikih, kjer so večanje odmerka omejili drugi dogodki, kot neželeni učinki zaradi načina delovanja zdravila Uptravi, se lahko razmisliti o drugem poskusu nadaljevanja večanja odmerka do največjega odmerka, ki ga posameznik še prenaša, do največ 1.600 mikrogramov dvakrat na dan.
English: Hospitalisation for PAH was observed in 86 (15.0%) patients on selexipag and 123 (21.1%) patients on placebo.
Slovenian: Hospitalizacijo zaradi PAH so opazili pri 86 (15,0 %) bolnikih na seleksipagu in 123 (21,1 %) bolnikih na placebu.
English: Titration diary
Slovenian: Dnevnik titriranja
English: The first intake of the increased dose should be in the evening.
Slovenian: Prvi vnos povečanega odmerka naj bo zvečer.
English: In a fertility study performed in rats, a prolongation of oestrus cycles resulting in increases in days until copulation was observed at exposures 173-fold above therapeutic exposures (based on total exposures), the no-observed-effect level being 30-fold above therapeutic exposures.
Slovenian: V študiji plodnosti pri podganah je podaljšanje estrusnih ciklov povzročilo podaljšanje dni do opažene kopulacije pri izpostavljenosti, ki je 173-krat večja od terapevtske izpostavljenosti (na podlagi skupnih izpostavljenosti), raven brez vidnega neželenega učinka pa je 30-krat večja od terapevtske izpostavljenosti.
English: Titration
Slovenian: Titriranje
English: The patients will receive an identical titration guide and Patient Leaflet in their titration packs of Uptravi.
Slovenian: Bolnik bo prejel identično navodilo za titriranje in navodilo za uporabo v titracijskem pakiranju zdravila Uptravi.
English: • Concomitant use of strong inhibitors of CYP2C8 (e.g., gemfibrozil; see section 4.5).
Slovenian: • Sočasna uporaba močnih zaviralcev CYP2C8 (npr. gemfibrozila; glejte poglavje 4.5).
English: If you are a woman who can have children, you should use an effective contraceptive method while taking Uptravi.
Slovenian: Če ste ženska v rodni dobi, morate med jemanjem zdravila Uptravi uporabljati učinkovito kontracepcijo.
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.
Slovenian: O zmanjšanju koncentracij hemoglobina na manj kot 10 g/dl glede na izhodišče so poročali pri 8,6 % bolnikov, zdravljenih s seleksipagom, in 5,0 % bolnikov, zdravljenih s placebom.
English: No change in starting dose is required in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2); dose titration should be done with caution in these patients (see section 4.4).
Slovenian: Začetnega odmerka pri bolnikih s hudo okvaro ledvic ni treba spreminjati (ocenjena hitrost glomerularne filtracije [eGFR-estimated glomerular filtration rate] < 30 ml/min/1,73 m2); pri teh bolnikih je potrebna previdnost pri titriranju odmerka (glejte poglavje 4.4).
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.
Slovenian: Izpostavljenost seleksipagu in njegovemu aktivnemu presnovku pri teh dveh osebah je bila podobna kot pri osebah z zmerno (razred B po Child-Pughu) okvaro jeter.
English: The recommended starting dose is 200 micrograms given twice daily, approximately 12 hours apart.
Slovenian: Priporočeni začetni odmerek je 200 mikrogramov dvakrat na dan s približno 12-urnim presledkom.
English: Uptravi is not recommended during pregnancy and breast-feeding.
Slovenian: Uporaba zdravila Uptravi med nosečnostjo in dojenjem ni priporočljiva.
English: Uptravi can cause side effects such as headaches and low blood pressure (see section 4), which may affect your ability to drive; the symptoms of your condition can also make you less fit to drive.
Slovenian: Zdravilo Uptravi lahko povzroči neželene učinke, kot sta glavobol in nizek krvni tlak (glejte poglavje 4), kar lahko vpliva na vašo sposobnost vožnje.
English: The diagram below shows the number of tablets to take every morning and every evening for the first 4 steps.
Slovenian: Spodnji diagram prikazuje število tablet, ki jih morate vzeti vsako jutro in vsak večer za prve 4 korake.
English: Your doctor will prescribe a suitable tablet strength for your maintenance dose.
Slovenian: Vaš zdravnik vam bo za vzdrževalni odmerek predpisal primerno jakost tablete.
English: The observed effect of selexipag versus placebo on the primary endpoint was consistent across individualised maintenance dose as shown by the hazard ratio for the three pre-defined categories (0.60 for 200-400 micrograms twice daily, 0.53 for 600-1,000 micrograms twice daily, and 0.64 for 1,200-1,600 micrograms twice daily), which was consistent with the overall treatment effect (0.60).
Slovenian: Opaženi učinek seleksipaga v primerjavi s placebom na primarni opazovani dogodek je bil konsistenten za vse individualne vzdrževalne odmerke, kot prikazuje razmerje tveganj za tri vnaprej določene kategorije (0,60 za 200-400 mikrogramov dvakrat na dan, 0,53 za 600-1.000 mikrogramov dvakrat na dan in 0,64 za 1.200-1.600 mikrogramov dvakrat na dan), ki je bil skladen s celokupnim učinkom zdravljenja (0,60).
English: Women of childbearing potential should practise effective contraception while taking selexipag.
Slovenian: Ženske v rodni dobi morajo med jemanjem seleksipaga uporabljati učinkovito kontracepcijo.
English: Figure 1 Kaplan-Meier estimates of the first morbidity-mortality event
Slovenian: Preglednica 1 Ocena prvega dogodka obolevnosti/smrti v študiji po Kaplan-Meierju
English: This lets you take just one tablet in the morning and one in the evening, instead of multiple tablets for each dose.
Slovenian: Tako boste lahko zjutraj in zvečer vzeli le eno tableto namesto več tablet za en odmerek.
English: Adverse reactions obtained from the pivotal clinical study are tabulated below.
Slovenian: Neželeni učinki, ki so jih opazili v osrednji klinični študiji, so povzeti v spodnji preglednici.
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.
Slovenian: V klinični praksi so opazili učinke na prebavila, ki so se odzvali na zdravila proti driski, proti bruhanju in proti siljenju na bruhanje in/ali na zdravila za funkcionalne prebavne motnje.
English: Tell your doctor if you experience side effects, as your doctor may recommend that you change your Uptravi dose.
Slovenian: Zdravniku povejte, če se pojavijo neželeni učinki, saj lahko zdravnik priporoči prilagoditev vašega odmerka zdravila Uptravi.
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.
Slovenian: Pri zdravih osebah seleksipag (400 mikrogramov dvakrat na dan) ni spremenil izpostavljenosti S-varfarinu (substrat CYP2C9) ali R-varfarinu (substrat CYP3A4) po enkratnem odmerku 20 mg varfarina.
English: The number of patients who experienced, as a first event, death due to PAH or hospitalisation for PAH up to end of treatment was 102 (17.8%) in the selexipag group and 137 (23.5%) in the placebo group.
Slovenian: Število bolnikov, ki so kot prvi dogodek doživeli smrt zaradi PAH ali bili zaradi PAH hospitalizirani do konca zdravljenja, je bil 102 (17,8 %) v skupini s seleksipagom in 137 (23,5 %) v skupini s placebom.
English: The goal is to reach the dose that is most appropriate to treat you.
Slovenian: Cilj je doseči odmerek, ki je najprimernejši za vaše zdravljenje.
English: Uptravi is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Zdravila Uptravi ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
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.
Slovenian: Pljučna hemodinamika V dvojno slepi, s placebom nadzorovani klinični študiji faze 2 so ocenjevali hemodinamične spremenljivke po 17 tednih zdravljenja pri bolnikih s PAH FR II-III po SZO, ki so sočasno prejemali ERA in/ali zaviralce PDE-5.
English: UGT1A3 and UGT2B7 are involved in the glucuronidation of the active metabolite.
Slovenian: UGT1A3 in UGT2B7 sodelujeta v glukuronidaciji aktivnega presnovka.
English: Uptravi is used for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients insufficiently controlled with other types of medicines for PAH known as endothelin receptor antagonists and phosphodiesterase type 5 inhibitors.
Slovenian: Zdravilo Uptravi se uporablja za dolgotrajno zdravljenje pljučne arterijske hipertenzije (PAH) pri odraslih bolnikih, pri katerih ni dosežen ustrezni nadzor nad boleznijo z drugimi zdravili za PAH, poznanimi kot antagonisti endotelijskih receptorjev in zaviralci fosfodiesteraze tipa 5.
English: As human EP4 receptors are not activated by selexipag or its active metabolite, this effect is species-specific and, therefore, not relevant to humans.
Slovenian: EP4 pri človeku ne aktivira, je ta učinek specifičen za vrsto, zato za ljudi ni pomemben.
English: Uptravi should be used with caution in this age group.
Slovenian: V tej starostni skupini je treba zdravilo Uptravi uporabljati previdno.
English: As with all medicines, you may experience side effects with Uptravi as you step up to higher doses.
Slovenian: Kot pri vseh zdravilih boste morda imeli neželene učinke pri povečevanju odmerka zdravila Uptravi.
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.
Slovenian: Napovedana izpostavljenost aktivnemu presnovku v stanju dinamičnega ravnovesja pri teh bolnikih z režimom enkrat na dan je podobna kot pri zdravih osebah z režimom dvakrat na dan.
English: In a thorough QT study in healthy subjects, repeated doses of 800 and 1,600 micrograms of selexipag twice daily did not show an effect on cardiac repolarisation (QTc interval) or conduction (PR and QRS intervals) and had a mild accelerating effect on heart rate (the placebo-corrected, baseline-adjusted increase in heart rate reached 6-7 bpm at 1.5 to 3 h after dosing with 800 micrograms selexipag and 9-10 bpm at the same timepoints after 1,600 micrograms selexipag).
Slovenian: V temeljiti študiji QT pri zdravih osebah ponavljajoči odmerki 800 in 1.600 mikrogramov seleksipaga dvakrat na dan niso pokazali učinka na repolarizacijo srca (interval QTc) ali prevodnost (intervala PR in QRS) in so imeli blag pospešujoči učinek na srčni utrip (za placebo korigirano, izhodiščno prilagojeno povečanje srčnega utripa je doseglo 6-7 utripov/minuto v 1,5 do 3 urah po odmerjanju
English: For patients with moderate hepatic impairment (Child-Pugh class B), the starting dose of Uptravi should be 200 micrograms once daily, and increased at weekly intervals by increments of 200 micrograms given once daily until adverse reactions, reflecting the mode of action of selexipag, that cannot be tolerated or medically managed are experienced.
Slovenian: Pri bolnikih z zmerno okvaro jeter (razred B po Child-Pughu) naj bo začetni odmerek zdravila Uptravi 200 mikrogramov enkrat na dan, nato pa se postopoma povečuje v tedenskih intervalih po 200 mikrogramov enkrat na dan, do neželenih učinkov zaradi načina delovanja seleksipaga, ki jih bolnik ne more prenašati ali niso zdravstveno obvladljivi.
English: If you have taken more tablets than you have been told to take, ask your doctor for advice.
Slovenian: Če ste vzeli večji odmerek zdravila Uptravi, kot bi smeli Če ste vzeli več tablet, kot vam je bilo naročeno, se posvetujte z zdravnikom.
English: Selexipag and its active metabolite both undergo oxidative metabolism mainly by CYP2C8 and to a smaller extent by CYP3A4.
Slovenian: Seleksipag in njegov aktivni presnovek oksidativno presnovi predvsem CYP2C8 in v manjši meri CYP3A4.
English: Your doctor or nurse may have you resume treatment at a lower dose, gradually increasing to your previous maintenance dose.
Slovenian: Vaš zdravnika ali medicinsko sestra vas lahko zdravita z nižjim odmerkom, ki ga postopoma povečujeta do prejšnjega vzdrževalnega odmerka.
English: The highest tolerated dose reached during dose titration should be maintained.
Slovenian: Največji odmerek, ki ga bolnik prenaša, dosežen s titriranjem odmerka, je treba vzdrževati.
English: The goal of titration is to reach the most appropriate dose.
Slovenian: Cilj titriranja je doseči odmerek, ki je za vas najprimernejši.
English: Your doctor may decide to restart your treatment on a lower dose, gradually increasing to your previous maintenance dose.
Slovenian: Vaš zdravnik se lahko odloči za nadaljevanje zdravljenja z nižjim odmerkom in postopnim povečevanjem do vašega prejšnjega vzdrževalnega odmerka.
English: It lets your body gradually adjust to the medicine.
Slovenian: Telesu omogoča, da se počasi navaja na zdravilo.
English: The exposure to selexipag and its active metabolite is increased in subjects with moderate hepatic impairment (Child-Pugh class B; see section 5.2).
Slovenian: Izpostavljenost seleksipagu in njegovim aktivnim presnovkom se poveča pri osebah z zmerno okvaro jeter (razred B po Child-Pughu; glejte poglavje 5.2).
English: Treatment with selexipag 200-1,600 micrograms twice daily resulted in a 40% reduction (hazard ratio [HR] 0.60; 99% CI: 0.46, 0.78; one-sided log-rank p value < 0.0001) of the occurrence of morbidity or mortality events up to 7 days after last dose compared to placebo (Figure 1).
Slovenian: Zdravljenje s seleksipagom 200-1.600 mikrogramov dvakrat na dan je povzročilo 40-% zmanjšanje (razmerje tveganja [RT] 0,60; 99-% IZ: 0,46; 0,78; vrednost p enostranskega testa log-rank < 0,0001) pojava obolevnosti ali smrti do 7 dni po zadnjem odmerku v primerjavi s placebom (slika 1).
English: Effect of selexipag on other medicinal products
Slovenian: Učinek seleksipaga na druga zdravila
English: Uptravi should only be prescribed by a doctor experienced in the treatment of PAH.
Slovenian: Zdravilo Uptravi vam lahko predpiše le zdravnik z izkušnjami z zdravljenjem PAH.
English: Inhibitors of UGT1A3 and UGT2B7
Slovenian: ZaviralciUGT1A3 in UGT2B7
English: Selexipag is hydrolysed to its active metabolite by carboxylesterases (see section 5.2).
Slovenian: Seleksipag se v svoj aktivni presnovek hidrolizira z karboksilesterazami (glejte poglavje 5.2).
English: ↓When should you step down?
Slovenian: ↓Kdaj zmanjšati odmerek?
English: Intra-subject variability in exposure was 24% and 19% for selexipag and the active metabolite, respectively.
Slovenian: Variabilnost izpostavljenosti med posamezniki je bila 24 % za seleksipag in 19 % za aktivni presnovek.
English: Thyroid function tests are recommended as clinically indicated in the presence of signs or symptoms of hyperthyroidism.
Slovenian: V prisotnosti znakov ali simptomov hipertiroidizma se priporoča opravljanje testov delovanja ščitnice, kot je klinično indicirano.
English: Uptravi 200 microgram film-coated tablets are supplied in blister packs of 10 or 60 tablets and 60 or 140 tablets (titration packs).
Slovenian: Uptravi 200 mikrogramov filmsko obložene tablete Škatle z 10 ali 60 filmsko obloženimi tabletami in 60 ali 140 filmsko obloženimi tabletami (titracijska pakiranja).
English: A delay in the closure of the femoral and/or tibial epiphyseal growth plate was observed in juvenile dogs.
Slovenian: Pri mladih psih so opazili zakasnjeno zapiranje stegenske in/ali tibialne epifizealne rastne ploščice.
English: There is no clinical experience with selexipag in patients with severe liver impairment (Child-Pugh class C), therefore Uptravi should not be administered in these patients.
Slovenian: Kliničnih izkušenj s seleksipagom pri bolnikih s hudo okvaro jeter (razred C po Child-Pughu) ni, zato bolniki zdravila Uptravi ne smejo prejemati.
English: Death due to PAH as a component of the endpoint was observed in 16 (2.8%) patients on selexipag and 14 (2.4%) on placebo.
Slovenian: Smrt zaradi PAH kot komponente opazovanega dogodka so opazili pri 16 (2,8 %) bolnikih na seleksipagu in 14 (2,4 %) bolnikih na placebu.
English: The number of deaths due to PAH up to study closure was 70 (12.2%) for the selexipag group and 83 (14.3%) for the placebo group.
Slovenian: Število smrti zaradi PAH do zaprtja študije je bilo 70 (12,2 %) za skupino s seleksipagom in 83 (14,3 %) za skupino s placebom.
English: • Tracking of the receipt of the kits by prescribers.
Slovenian: • sledenje prejemnikov kompletov, ki ga izvajajo zdravniki, ki zdravilo predpisujejo.
English: Do not use Uptravi after the expiry date, which is stated on the carton and on the blister after “EXP.” The expiry date refers to the last day of that month.
Slovenian: Zdravila Uptravi ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake "EXP".
English: No evidence for acute rebound has been observed.
Slovenian: Dokazov o akutnem izbruhu bolezni niso opazili.
English: (a) % of patients with an event at 36 months = 100 × (1 - Kaplan-Meier estimate); hazard ratio estimated using Cox's proportional hazard model; unstratified one-sided log-rank p-value (b) % of patients with an event as part of the primary endpoint up to EOT + 7 days; hazard ratio estimated using Aalen Johansen method; 2-sided p-value using Gray's test (c) Includes ‘Need for lung transplantation or atrial septostomy' (1 patient on selexipag and 2 on placebo) (d) % of patients with an event up to EOT + 7 days or up to study closure; hazard ratio estimated using Cox's proportional hazard model; unstratified one-sided log-rank p-value
Slovenian: (a) % bolnikov z dogodkom v 36. mesecu = 100 × (1 - ocena po Kaplan-Meierju); razmerje tveganj, ocenjeno s Coxovim modelom sorazmerne ogroženosti; nestratificirana vrednost p enostranskega testa log-rank (b) % bolnikov z dogodkom kot del primarnega opazovanega dogodka do EOT + 7 dni; razmerje tveganja, ocenjeno z Aalen Johansenovo metodo; 2-stranska vrednost p, pridobljena z Grayevim testom
English: The patient titration guide along with the Patient Information Leaflet should be given to the patient after the demonstration.
Slovenian: Navodilo za titriranje za bolnika je treba bolniku po prikazu izročiti skupaj z navodilom za uporabo.
English: • Lay language version of the healthcare professional A4 laminated titration guide;
Slovenian: • različico laminiranega navodila za titriranje zdravila velikosti A4 za zdravstvene delavce v poljudnem jeziku;
English: Concomitant administration of Uptravi with strong inhibitors of CYP2C8 (e.g., gemfibrozil) is contraindicated (see section 4.3).
Slovenian: Sočasna uporaba zdravila Uptravi z močnimi zaviralci CYP2C8 (npr. z gemfibrozilom) je kontraindicirana (glejte poglavje 4.3).
English: There are treatments available that can help relieve them.
Slovenian: Za lajšanje so na voljo zdravljenja.
English: Dosage Adjustment with Co-administration of Moderate CYP2C8 Inhibitors
Slovenian: Prilagoditev odmerka pri sočasni uporabi zmernih zaviralcev CYP2C8
English: The mean age was 48.1 years (range 18-80 years of age), with the majority of subjects being
Slovenian: Povprečna starost je bila 48,1 let (razpon 18-80 let), pri čemer je bila večina oseb belcev (65,0 %) in žensk (79,8 %).
English: Anticoagulants or inhibitors of platelet aggregation
Slovenian: Antikoagulanti ali zaviralci agregacije trombocitov
English: Maximum observed plasma concentrations of selexipag and its active metabolite after oral administration are reached within 1-3 h and 3-4 h, respectively.
Slovenian: Največje opažene koncentracije seleksipaga in njegovega aktivnega presnovka v plazmi po peroralni uporabi so bile dosežene v 1-3 urah oz. 3-4 urah.
English: Uptravi is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with WHO functional class (FC) II-III, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies.
Slovenian: Zdravilo Uptravi je indicirano za dolgotrajno zdravljenje pljučne arterijske hipertenzije (PAH) pri odraslih bolnikih s funkcionalnim razredom II do III po SZO, bodisi kot kombinirano zdravljenje pri bolnikih, pri katerih z antagonisti endotelinskih receptorjev (ERA, endothelin receptor antagonist) in/ali zaviralcem fosfodiesteraze tipa 5 (FDE-5) ni dosežen ustrezni nadzor nad boleznijo, ali kot monoterapija pri bolnikih, ki niso kandidati za te oblike zdravljenj.