natgillin/translations-raw huggingface dataset:
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%).
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
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.
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.
Hospitalisation for PAH was observed in 86 (15.0%) patients on selexipag and 123 (21.1%) patients on placebo.
Hospitalizacijo zaradi PAH so opazili pri 86 (15,0 %) bolnikih na seleksipagu in 123 (21,1 %) bolnikih na placebu.
Titration diary
Dnevnik titriranja
The first intake of the increased dose should be in the evening.
Prvi vnos povečanega odmerka naj bo zvečer.
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.
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.
Titration
Titriranje
The patients will receive an identical titration guide and Patient Leaflet in their titration packs of Uptravi.
Bolnik bo prejel identično navodilo za titriranje in navodilo za uporabo v titracijskem pakiranju zdravila Uptravi.
• Concomitant use of strong inhibitors of CYP2C8 (e.g., gemfibrozil; see section 4.5).
• Sočasna uporaba močnih zaviralcev CYP2C8 (npr. gemfibrozila; glejte poglavje 4.5).
If you are a woman who can have children, you should use an effective contraceptive method while taking Uptravi.
Če ste ženska v rodni dobi, morate med jemanjem zdravila Uptravi uporabljati učinkovito kontracepcijo.
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.
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.
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).
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).
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.
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.
The recommended starting dose is 200 micrograms given twice daily, approximately 12 hours apart.
Priporočeni začetni odmerek je 200 mikrogramov dvakrat na dan s približno 12-urnim presledkom.
Uptravi is not recommended during pregnancy and breast-feeding.
Uporaba zdravila Uptravi med nosečnostjo in dojenjem ni priporočljiva.
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.
Zdravilo Uptravi lahko povzroči neželene učinke, kot sta glavobol in nizek krvni tlak (glejte poglavje 4), kar lahko vpliva na vašo sposobnost vožnje.
The diagram below shows the number of tablets to take every morning and every evening for the first 4 steps.
Spodnji diagram prikazuje število tablet, ki jih morate vzeti vsako jutro in vsak večer za prve 4 korake.
Your doctor will prescribe a suitable tablet strength for your maintenance dose.
Vaš zdravnik vam bo za vzdrževalni odmerek predpisal primerno jakost tablete.
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).
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).
Women of childbearing potential should practise effective contraception while taking selexipag.
Ženske v rodni dobi morajo med jemanjem seleksipaga uporabljati učinkovito kontracepcijo.
Figure 1 Kaplan-Meier estimates of the first morbidity-mortality event
Preglednica 1 Ocena prvega dogodka obolevnosti/smrti v študiji po Kaplan-Meierju
This lets you take just one tablet in the morning and one in the evening, instead of multiple tablets for each dose.
Tako boste lahko zjutraj in zvečer vzeli le eno tableto namesto več tablet za en odmerek.
Adverse reactions obtained from the pivotal clinical study are tabulated below.
Neželeni učinki, ki so jih opazili v osrednji klinični študiji, so povzeti v spodnji preglednici.
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.
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.
Tell your doctor if you experience side effects, as your doctor may recommend that you change your Uptravi dose.
Zdravniku povejte, če se pojavijo neželeni učinki, saj lahko zdravnik priporoči prilagoditev vašega odmerka zdravila Uptravi.
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.
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.
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.
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.
The goal is to reach the dose that is most appropriate to treat you.
Cilj je doseči odmerek, ki je najprimernejši za vaše zdravljenje.
Uptravi is not recommended during pregnancy and in women of childbearing potential not using contraception.
Zdravila Uptravi ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
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.
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.
UGT1A3 and UGT2B7 are involved in the glucuronidation of the active metabolite.
UGT1A3 in UGT2B7 sodelujeta v glukuronidaciji aktivnega presnovka.
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.
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.
As human EP4 receptors are not activated by selexipag or its active metabolite, this effect is species-specific and, therefore, not relevant to humans.
EP4 pri človeku ne aktivira, je ta učinek specifičen za vrsto, zato za ljudi ni pomemben.
Uptravi should be used with caution in this age group.
V tej starostni skupini je treba zdravilo Uptravi uporabljati previdno.
As with all medicines, you may experience side effects with Uptravi as you step up to higher doses.
Kot pri vseh zdravilih boste morda imeli neželene učinke pri povečevanju odmerka zdravila Uptravi.
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.
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.
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).
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
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.
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.
If you have taken more tablets than you have been told to take, ask your doctor for advice.
Če ste vzeli večji odmerek zdravila Uptravi, kot bi smeli Če ste vzeli več tablet, kot vam je bilo naročeno, se posvetujte z zdravnikom.
Selexipag and its active metabolite both undergo oxidative metabolism mainly by CYP2C8 and to a smaller extent by CYP3A4.
Seleksipag in njegov aktivni presnovek oksidativno presnovi predvsem CYP2C8 in v manjši meri CYP3A4.
Your doctor or nurse may have you resume treatment at a lower dose, gradually increasing to your previous maintenance dose.
Vaš zdravnika ali medicinsko sestra vas lahko zdravita z nižjim odmerkom, ki ga postopoma povečujeta do prejšnjega vzdrževalnega odmerka.
The highest tolerated dose reached during dose titration should be maintained.
Največji odmerek, ki ga bolnik prenaša, dosežen s titriranjem odmerka, je treba vzdrževati.
The goal of titration is to reach the most appropriate dose.
Cilj titriranja je doseči odmerek, ki je za vas najprimernejši.
Your doctor may decide to restart your treatment on a lower dose, gradually increasing to your previous maintenance dose.
Vaš zdravnik se lahko odloči za nadaljevanje zdravljenja z nižjim odmerkom in postopnim povečevanjem do vašega prejšnjega vzdrževalnega odmerka.
It lets your body gradually adjust to the medicine.
Telesu omogoča, da se počasi navaja na zdravilo.
The exposure to selexipag and its active metabolite is increased in subjects with moderate hepatic impairment (Child-Pugh class B; see section 5.2).
Izpostavljenost seleksipagu in njegovim aktivnim presnovkom se poveča pri osebah z zmerno okvaro jeter (razred B po Child-Pughu; glejte poglavje 5.2).
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).
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).
Effect of selexipag on other medicinal products
Učinek seleksipaga na druga zdravila
Uptravi should only be prescribed by a doctor experienced in the treatment of PAH.
Zdravilo Uptravi vam lahko predpiše le zdravnik z izkušnjami z zdravljenjem PAH.
Inhibitors of UGT1A3 and UGT2B7
ZaviralciUGT1A3 in UGT2B7
Selexipag is hydrolysed to its active metabolite by carboxylesterases (see section 5.2).
Seleksipag se v svoj aktivni presnovek hidrolizira z karboksilesterazami (glejte poglavje 5.2).
↓When should you step down?
↓Kdaj zmanjšati odmerek?
Intra-subject variability in exposure was 24% and 19% for selexipag and the active metabolite, respectively.
Variabilnost izpostavljenosti med posamezniki je bila 24 % za seleksipag in 19 % za aktivni presnovek.
Thyroid function tests are recommended as clinically indicated in the presence of signs or symptoms of hyperthyroidism.
V prisotnosti znakov ali simptomov hipertiroidizma se priporoča opravljanje testov delovanja ščitnice, kot je klinično indicirano.
Uptravi 200 microgram film-coated tablets are supplied in blister packs of 10 or 60 tablets and 60 or 140 tablets (titration packs).
Uptravi 200 mikrogramov filmsko obložene tablete Škatle z 10 ali 60 filmsko obloženimi tabletami in 60 ali 140 filmsko obloženimi tabletami (titracijska pakiranja).
A delay in the closure of the femoral and/or tibial epiphyseal growth plate was observed in juvenile dogs.
Pri mladih psih so opazili zakasnjeno zapiranje stegenske in/ali tibialne epifizealne rastne ploščice.
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.
Kliničnih izkušenj s seleksipagom pri bolnikih s hudo okvaro jeter (razred C po Child-Pughu) ni, zato bolniki zdravila Uptravi ne smejo prejemati.
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.
Smrt zaradi PAH kot komponente opazovanega dogodka so opazili pri 16 (2,8 %) bolnikih na seleksipagu in 14 (2,4 %) bolnikih na placebu.
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.
Število smrti zaradi PAH do zaprtja študije je bilo 70 (12,2 %) za skupino s seleksipagom in 83 (14,3 %) za skupino s placebom.
• Tracking of the receipt of the kits by prescribers.
• sledenje prejemnikov kompletov, ki ga izvajajo zdravniki, ki zdravilo predpisujejo.
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.
Zdravila Uptravi ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake "EXP".
No evidence for acute rebound has been observed.
Dokazov o akutnem izbruhu bolezni niso opazili.
(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
(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
The patient titration guide along with the Patient Information Leaflet should be given to the patient after the demonstration.
Navodilo za titriranje za bolnika je treba bolniku po prikazu izročiti skupaj z navodilom za uporabo.
• Lay language version of the healthcare professional A4 laminated titration guide;
• različico laminiranega navodila za titriranje zdravila velikosti A4 za zdravstvene delavce v poljudnem jeziku;
Concomitant administration of Uptravi with strong inhibitors of CYP2C8 (e.g., gemfibrozil) is contraindicated (see section 4.3).
Sočasna uporaba zdravila Uptravi z močnimi zaviralci CYP2C8 (npr. z gemfibrozilom) je kontraindicirana (glejte poglavje 4.3).
There are treatments available that can help relieve them.
Za lajšanje so na voljo zdravljenja.
Dosage Adjustment with Co-administration of Moderate CYP2C8 Inhibitors
Prilagoditev odmerka pri sočasni uporabi zmernih zaviralcev CYP2C8
The mean age was 48.1 years (range 18-80 years of age), with the majority of subjects being
Povprečna starost je bila 48,1 let (razpon 18-80 let), pri čemer je bila večina oseb belcev (65,0 %) in žensk (79,8 %).
Anticoagulants or inhibitors of platelet aggregation
Antikoagulanti ali zaviralci agregacije trombocitov
Maximum observed plasma concentrations of selexipag and its active metabolite after oral administration are reached within 1-3 h and 3-4 h, respectively.
Največje opažene koncentracije seleksipaga in njegovega aktivnega presnovka v plazmi po peroralni uporabi so bile dosežene v 1-3 urah oz. 3-4 urah.
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.
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.
Based on modelling and simulation data from a study in subjects with hepatic impairment, the exposure to selexipag at steady state in subjects with moderate hepatic impairment (Child-Pugh class B) after a once-daily regimen is predicted to be approximately 2-fold higher than that in healthy subjects during a twice-daily regimen.
Na podlagi modeliranja in simulacijskih podatkov iz študije z osebami z okvaro jeter je bila napovedana izpostavljenost seleksipagu v stanju dinamičnega ravnovesja pri osebah z zmerno okvaro jeter (razred B po Child-Pughu) z režimom enkrat na dan približno 2-krat večja kot pri zdravih osebah z režimom dvakrat na dan.
Please read the instructions in the package leaflet carefully.
Natančno preberite napotke v navodilu za uporabo.
When co-administered with moderate CYP2C8 inhibitors (e.g., clopidogrel, deferasirox and teriflunomide), reduce the dosing of Uptravi to once daily.
Pri sočasni uporabi z zmernimi zaviralci CYP2C8 (npr. klopidogrelom, deferasiroksom in teriflunomidom) znižajte odmerek zdravila Uptravi na enkrat na dan.
The following diary pages help you keep track of the number of tablets you need to take in the morning and evening during titration.
Naslednje strani dnevnika vam bodo pomagale pri sledenju števila tablet, ki jih morate vzeti zjutraj in zvečer med povečevanjem odmerka.
Like all medicines, Uptravi can cause side effects.
Kot vsa zdravila ima lahko tudi zdravilo Uptravi neželene učinke.
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.
spola, ras, etiologije, zemljepisne regije, FK po SZO, in kot monoterapija ali v kombinaciji z ERA ali zaviralcem PDE-5 ali kot trojna kombinacija z ERA in zaviralcem PDE-5.
What Uptravi looks like and contents of the pack
Izgled zdravila Uptravi in vsebina pakiranja
If the therapy over time is less tolerated at a given dose, symptomatic treatment and/or a dose reduction to the next lower dose should be considered.
Če zdravljenje z danim odmerkom bolnik sčasoma slabše prenaša, je treba razmisliti o simptomatskem zdravljenju in/ali zmanjšanju odmerka do naslednjega manjšega odmerka.
Selexipag is rapidly absorbed and is hydrolysed by carboxylesterases to its active metabolite.
Absorpcija Seleksipag se hitro absorbira in v hidrolizira s karboksilesterazami v svoj aktivni presnovek.
If it is nearly time for your next dose (within 6 hours before you would normally take it), you should skip the missed dose and continue to take your medicine at the usual time.
Če je skoraj že čas za naslednji odmerek (manj kot 6 ur pred naslednjim odmerkom), preskočite izpuščeni odmerek in nato nadaljujte z jemanjem zdravila ob običajnem času.
How to take Uptravi
Kako jemati zdravilo Uptravi
Use them to write down the number of tablets you take in the morning and the evening.
V dnevnik zabeležite število tablet, ki jih vzamete zjutraj in zvečer.
Your doctor may have you step up from the starting dose to higher doses of Uptravi.
Vaš zdravnik bo morda povečal začetni odmerek zdravila Uptravi.
In subjects with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment, exposure to selexipag was 2- and 4-fold higher, respectively, when compared to healthy subjects.
Okvara jeter Pri osebah z blago (razred A po Child-Pughu) ali zmerno (razred B po Child-Pughu) okvaro jeter je bila izpostavljenost seleksipagu 2- oz. 4-krat večja v primerjavi z zdravimi osebami.
Approximately 1%, 46%, 53%, and 1% of patients were in WHO FC I, II, III and IV, respectively, at baseline.
Glede na FR po SZO je približno 1 % bolnikov je sodilo v razred I, 46 % v razred II, 53 % v razred III in 1 % v razred IV.
If you forget to take Uptravi.....................................16 If you stop taking Uptravi.........................................17 Titration diary...........................................................18
Če ste pozabili vzeti zdravilo Uptravi..........16 Če prenehate jemati zdravilo Uptravi .........17