natgillin/translations-raw huggingface dataset:
If you forget to take Uptravi, take a dose as soon as you remember, then continue to take your tablets at the usual times.
Če ste pozabili vzeti zdravilo Uptravi, ga vzemite takoj, ko se spomnite in nato s tabletami nadaljujte ob običajnem času.
If your titration steps last longer than 1 week there are additional diary pages to track this.
Če trajajo vaši koraki povečevanja odmerka dlje kot 1 teden, to beležite na dodatne strani v dnevniku.
Concomitant administration of Uptravi with clopidogrel (loading dose of 300 mg or maintenance dose of 75 mg once a day), a moderate inhibitor of CYP2C8, had no relevant effect on the exposure to selexipag but increased the exposure to the active metabolite approximately 2.2 and 2.7-fold following loading dose and maintenance dose, respectively.
Sočasna uporaba zdravila Uptravi s klopidogrelom (uvajalni odmerek 300 mg ali vzdrževalni odmerek 75 mg enkrat na dan), zmernim zaviralcem CYP2C8, ni imela imela pomembnega učinka na izpostavljenost seleksipagu, vendar je izpostavljenost aktivnemu presnovku povečala za približno 2,2krat po uvajalnem odmerku in približno 2,7-krat po vzdrževalnem odmerku.
In patients without concurrent PAH-specific therapy, the placebo-corrected treatment effect measured at trough was 34 m (99% CI: 10, 63 m).
specifičnim za PAH, je bil za placebo korigiran učinek zdravljenja, izmerjen tik pred naslednjim odmerkom, 34 m (99.% IZ: 10, 63 m).
Hyperthyroidism has been observed with Uptravi.
Pri uporabi zdravila Uptravi so opazili hipertiroidizem.
In the presence of 600 mg rifampicin, once a day, an inducer of CYP2C8 (and UGT enzymes), the exposure to selexipag did not change, whereas exposure to the active metabolite was reduced by half.
V prisotnosti 600 mg rifampicina enkrat dnevno, induktorja CYP2C8 (in encimov UGT) se izpostavljenost seleksipagu ni spremenila, medtem ko se je izpostavljenost aktivnemu presnovku zmanjšala za polovico.
If your doctor tells you to increase your dose further, you will add one 200 microgram tablet to your morning dose and one 200 microgram tablet to your evening dose with each new step.
Če vam zdravnik naroči dodatno povečanje odmerka, dodajte eno 200-mikrogramsko tableto jutranjemu odmerku in eno 200-mikrogramsko tableto večernemu odmerku z vsakim novim korakom.
Midazolam At steady state after up-titration to 1,600 μg selexipag twice a day, no clinically relevant change in exposure to midazolam, a sensitive intestinal and hepatic CYP3A4 substrate, or its metabolite, 1-hydroxymidazolam, was observed.
V stanju ravnovesja po povečevanju odmerka do 1.600 μg seleksipaga dvakrat na dan niso opazili klinično pomembnih sprememb izpostavljenosti midazolamu, občutljivemu substratu črevesnega in jetrnega CYP3A4, ali njegovemu presnovku 1-hidroksimidazolamu.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - TITRATION PACK
PODATKI NA ZUNANJI OVOJNINI ŠKATLA - TITRACIJSKO PAKIRANJE
Median 6MWD at baseline was 376 m (range: 90-482 m) and 369 m (range: 50-515 m) in selexipag patients and placebo patients, respectively.
376 m (razpon: 90-482 m) oz. 369 m (razpon: 50-515 m) pri bolnikih s seleksipagom oz. pri bolnikih s placebom.
During titration, you may experience side effects such as headache, diarrhoea, feeling sick (nausea), being sick (vomiting), jaw pain, muscle pain, leg pain, joint pain, or reddening of the face (see section 4).
Med titracijo lahko doživite neželene učinke, kot so glavobol, driska, občutek siljenja na bruhanje (navzea), bruhanje, bolečine v čeljustih, bolečine v mišicah, bolečine v nogah, bolečine v sklepih ali rdečina obraza (glejte poglavje 4).
In the Phase 3 placebo-controlled study in patients with PAH, a transient increase in mean heart rate of 3-4 bpm at 2-4 hours post-dose was observed.
Povečan srčni utrip V študiji faze 3, nadzorovani s placebom, pri bolnikih s PAH so opazili prehodno povečanje povprečnega srčnega utripa za 3-4 utripov/minuto 2-4 ure po odmerku.
Each patient should be up-titrated to the highest individually tolerated dose, which can range from 200 micrograms given twice daily to 1,600 micrograms given twice daily (individualised maintenance dose).
Individualizirano titriranje odmerka Pri vsakem bolniku je treba odmerek povečevati do največjega odmerka, ki ga lahko posameznik še prenaša, ki je lahko v razponu od 200 mikrogramov, danih dvakrat na dan, do 1.600 mikrogramov, danih dvakrat na dan (individualizirani vzdrževalni odmerek).
The first intake of Uptravi should be in the evening.
Prvi vnos zvečanega odmerka naj bo zvečer.
The doctor may then prescribe you a lower single-tablet strength.
Zdravnik vam lahko zdravilo predpiše kot eno tableto z nižjo jakostjo.
Cases of pulmonary oedema have been reported with vasodilators (mainly prostacyclins) when used in patients with pulmonary veno-occlusive disease.
Pri uporabi vazodilatatorjev (v glavnem prostaciklinov) pri bolnikih s pljučno vensko-okluzivno boleznijo so poročali o primerih pljučnega edema.
The risk of an event for this endpoint was reduced by 30% in patients receiving selexipag compared to placebo (HR 0.70, 99% CI: 0.50, 0.98; one-sided log-rank p = 0.0031).
Tveganje za dogodek za ta opazovani dogodek je bilo pri bolnikih, ki so prejemali seleksipag, za 30 % manjše v primerjavi s placebom (RT 0,70; 99-% IZ: 0,50; 0,98; vrednost p enostranskega testa log-rank = 0,0031).
In the Phase 3 placebo-controlled study in patients with PAH, no increased risk of bleeding was detected with selexipag compared to placebo, including when selexipag was administered with anticoagulants (such as heparin, coumarin-type anticoagulants) or inhibitors of platelet aggregation.
V preskušanjih faze 3, nadzorovanih s placebom, pri bolniki s PAH, uporaba seleksipaga v primerjavi s placebom ni povzročila večjega tveganja za krvavitev, vključno z dajanjem seleksipaga skupaj z antikoagulanti (kot so heparin,
Subjects with severe hepatic impairment (Child-Pugh class C) showed similar predicted exposure at steady state as subjects with moderate hepatic impairment during a once-daily regimen.
Pri osebah s hudo okvaro jeter (razred C po Child-Pughu) je bila napovedana izpostavljenost v stanju dinamičnega ravnovesja podobna kot pri osebah z zmerno okvaro jeter z režimom enkrat na dan.
The pharmacokinetics of selexipag and the active metabolite in PAH patients were not influenced by the severity of the disease and did not change with time.
Resnost bolezni pri bolnikih s PAH ni vplivala na farmakokinetiko seleksipaga in aktivnega presnovka, ki se s časom ni spremenila.
- The active substance is selexipag.
- Učinkovina je seleksipag.
Mannitol (E421), maize starch, low substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate.
Jedro tablete: manitol (E421), koruzni škrob, delno substituirana hidroksipropilceluloza, hidroksipropilceluloza, magnezijev stearat
Uptravi is a medicine that contains the active substance selexipag.
Zdravilo Uptravi vsebuje zdravilno učinkovino seleksipag.
Adverse reactions associated with the mode of action of selexipag have been observed frequently, in particular during the phase of individualised dose titration, and are tabulated below:
Farmakološki učinki, povezani s titriranjem odmerka in vzdrževalnim zdravljenjem Neželene učinke, povezane z načinom delovanja seleksipaga, so opazili pogosto, zlasti med fazo individualiziranega titriranja odmerka, in so povzeti spodaj: Prostaciklinu podobni povezani neželeni učinki
• Healthcare professional A4 laminated titration guide;
• laminirano navodilo za titriranje zdravila velikosti A4 za zdravstvene delavce;
You should only step down after speaking with your PAH doctor or nurse.
Odmerek zmanjšajte šele, ko se posvetujete z zdravnikom ali medicinsko sestro za PAH.
In juvenile dogs, intussusception due to prostacyclin-related effects on intestinal motility was observed sporadically.
Pri mladih psih so sporadično opazili invaginacijo zaradi učinkov,
Your doctor or nurse can prescribe an equivalent single-tablet strength for your maintenance dose.
Vaš zdravnik ali medicinska sestra vam lahko kot vzdrževalni odmerek predpišeta eno tableto z ustrezno jakostjo.
Treatment comparison: selexipag vs placebo
Primerjava zdravljenja: seleksipag v primerjavi s placebom
This includes any possible side effects not listed in this leaflet.
Posvetujte se tudi, če opazite katere koli neželene učinke, ki niso navedeni v tem navodilu
More subjects reported adverse events after administration in the fasted than in the fed state.
Več oseb je poročalo o neželenih učinkih na tešče kot po obroku.
In Phase 1 and 2 studies a slight decrease in plasma levels of von Willebrand factor (vWF) was observed with selexipag; the vWF values remained above the lower limit of the normal range.
V študijah faze 1 in 2 so s seleksipagom opazili rahlo zmanjšanje von Willebrandovega faktorja (vWF) v plazmi.
If the therapy is not tolerated at a given dose, symptomatic treatment and/or a dose reduction to the next lower dose should be considered.
Če bolnik zdravljenja z uporabljenim odmerkom ne prenaša, je treba razmisliti o uvedbi simptomatskega zdravljenja in/ali zmanjšanju odmerka do naslednjega manjšega odmerka.
Hypotension (see section 4.4)
(glejte poglavje 4.4)
Dose adjustment of selexipag may be required with concomitant administration of inducers of CYP2C8 (e.g., rifampicin, carbamazepine, phenytoin).
Pri sočasni uporabi induktorjev CYP2C8 (npr. rifampicina, karbamazepina,
Titration Guide
Navodila za titriranje
No adjustment to the dose regimen is needed in patients with mild or moderate renal impairment.
Okvara ledvic Pri bolnikih z blago ali zmerno okvaro ledvic režima odmerjanja ni treba prilagajati.
Do not stop taking Uptravi unless your doctor or nurse tells you to.
Če prenehate jemati zdravilo Uptravi Ne prenehajte jemati zdravila Uptravi, razen če vam to naroči zdravnik ali medicinska sestra.
Your doctor may tell you to reduce the dose gradually before stopping completely.
Zdravnik vam bo morda svetoval, da pred opustitvijo zdravila odmerek postopoma zmanjšujete.
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.
3 jutranje in 3 večerne odmerke ali 6 odmerkov zaporedoma), se takoj posvetujte z zdravnikom, saj bo zaradi preprečevanja neželenih učinkov morda treba odmerek prilagoditi.
Contents of the package and other information
Shranjevanje zdravila Uptravi Vsebina pakiranja in dodatne informacije
Selexipag reduced the risk of hospitalisation for PAH as a first outcome event compared to placebo (HR 0.67, 99% CI: 0.46, 0.98; one-sided log-rank p = 0.04).
Kot prvi izid je seleksipag zmanjšal tveganje hospitalizacije zaradi PAH v primerjavi s placebom (RT 0,67; 99-% IZ: 0,46; 0,98; vrednost p enostranskega testa log-rank = 0,04).
Remember to talk to your PAH doctor or nurse regularly.
Ne pozabite na redne pogovore o svoji PAH z zdravnikom ali medicinsko sestro.
Consequently, if signs of pulmonary oedema occur when Uptravi is administered in patients with PAH, the possibility of pulmonary veno-occlusive disease should be considered.
Posledično je treba pomisliti na možnost pljučne vensko-okluzivne bolezni, če se pojavijo znaki pljučnega edema pri bolnikih s PAH, ki dobivajo zdravilo Uptravi.
Use the following diary pages if your doctor or nurse prescribes 800 microgram tablets in addition to your 200 microgram tablets.
Če vam zdravnik ali medicinska sestra poleg vaših 200-mikrogramskih tablet predpiše tudi 800-mikrogramske tablete, uporabite naslednje strani v dnevniku.
If it is within 6 hours of when you would normally take your next dose, you should skip the missed dose and continue to take your medicine at the usual time.
Če bi naslednji odmerek običajno vzeli znotraj 6 ur, preskočite izpuščeni odmerek in nato nadaljujte z jemanjem zdravila ob običajnem času.
Uptravi film-coated tablets selexipag
Uptravi filmsko obložene tablete seleksipag
Morbiditymortality event a
Dogodek obolevnosti/smrt a
When should you step down?
Kdaj zmanjšati odmerek?
Idiopathic or heritable PAH was the most common aetiology in the study population (58%) followed by PAH due to connective tissue disorders (29%), PAH associated with simple corrected congenital heart disease (10%), and PAH associated with other aetiologies (drugs and toxins [2%] and HIV
zaradi bolezni vezivnega tkiva (29 %), PAH, povezana s popravljeno preprosto prirojeno boleznijo srca (10 %) in PAH, povezana z drugimi vzroki (zdravila in toksini [2 %] in HIV [1 %]).
Revert to twice daily dosing frequency of Uptravi when co-administration of moderate CYP2C8 inhibitor is stopped (see section 4.5).
Odmerek zdravila Uptravi ponovno jemljite dvakrat na dan, ko prenehate s sočasno uporabo zmernega zaviralca CYP2C8 (glejte poglavje 4.5).
Use pages 20 to 27 to track the first weeks of treatment, when you are using 200 microgram tablets only (steps 1-4).
Za sledenje prvih tednov zdravljenja uporabite strani 20 do 27, ko uporabljate
Decreased appetite Weight decrease
Presnovne in prehranske motnje zmanjšan apetit zmanjšanje telesne mase
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The glucuronidation of the active metabolite is catalysed by UGT1A3 and UGT2B7.
Glukuronidacijo aktivnega presnovka katalizirata UGT1A3 in UGT2B7.
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If you notice any of the above signs or your condition changes, tell your doctor immediately.
- če imate ali ste imeli hude težave z nepravilnim delovanjem jeter Če opazite katerega koli od zgornjih znakov ali spremembo svojega stanja, se takoj posvetujte z zdravnikom.
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
PAH ali napredovanja PAH, zaradi česar je bila potrebna presaditev pljuč ali balonska atrijska septostomija ali uvedba parenteralnega prostanoidnega zdravljenja ali kroničnega zdravljenja s kisikom ali drugi dogodki napredovanja bolezni (bolniki s FK II ali III po SZO ob izhodišču), potrjeno z zmanjšanjem razdalje, prehojene v 6-minutah (6MWD-6-minute walk distance) od izhodišča
Take Uptravi once in the morning and once in the evening, about 12 hours apart.
Zdravilo Uptravi vzemite zjutraj in zvečer z 12-urnim presledkom.
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Uptravi should not be administered in patients with severe liver impairment (Child-Pugh class C; see section 4.4).
Pri bolnikih z resno okvaro jeter (razred C po Child-Pughu) zdravila Uptravi ni dovoljeno uporabljati (glejte poglavje 4.4).
In the presence of 600 mg gemfibrozil, twice a day, a strong inhibitor of CYP2C8, exposure to selexipag increased approximately 2-fold, whereas exposure to the active metabolite, the major contributor to efficacy, increased approximately 11-fold.
Zaviralci CYP2C8 V prisotnosti 600 mg gemfibrozila dvakrat na dan, močnega zaviralca CYP2C8, se je izpostavljenost seleksipagu povečala za približno 2-krat, medtem ko se je izpostavljenost aktivnemu presnovku, ki veliko prispeva k učinkovitosti zdravila, povečala za približno 11-krat.
Talk to your PAH doctor or nurse before taking Uptravi if you - are taking medicines for high blood pressure - have low blood pressure associated with symptoms such as dizziness - have recently experienced significant blood loss or fluid loss such as severe diarrhoea or vomiting - have problems with your thyroid gland - have severe problems with your kidneys or are undergoing dialysis - have or have had severe problems with your liver not working properly
- imate nizek krvni tlak s simptomi, kot je omotičnost - ste pred kratkim izgubili veliko krvi ali tekočine, na primer zaradi hude driske ali bruhanja - imate težave s ščitnico
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If you miss a dose, take the dose as soon as you remember, then continue to take your tablets at the usual times.
Če ste pozabili vzeti zdravilo Uptravi Če ste izpustili odmerek, ga vzemite takoj, ko se spomnite, in nato s tabletami nadaljujte ob običajnem času.
Dosing frequency of Uptravi should be reverted to twice daily when co-administration of moderate CYP2C8 inhibitor is stopped (see section 4.2).
Uptravi je treba ponovno povečati na dvakrat na dan, ko prenehate s sočasno uporabo zmernega zaviralca CYP2C8 (glejte poglavje 4.2).
If you have any side effects, talk to your doctor.
Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom.
The most commonly reported adverse reactions are headache, diarrhoea, nausea and vomiting, jaw pain, myalgia, pain in extremity, arthralgia, and flushing.
Najpogostejši neželeni učinki so glavobol, driska, navzea in bruhanje, bolečine v čeljustih, mialgija, bolečine v okončinah, artralgija in vročinski oblivi.
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Blood and lymphatic disorders
Bolezni krvi in limfatičnega sistema anemija zmanjšanje vrednosti hemoglobina
- If you have any side effects, talk to your doctor or nurse.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali medicinsko sestro.
Selexipag is an inhibitor of platelet aggregation in vitro.
Seleksipag je in vitro zaviralec agregacije trombocitov.
PAH-specific therapies
Terapije, specifične za PAH
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With each step, you will add one 200 microgram tablet to your morning dose and another 200 microgram tablet to your evening dose.
Z vsakim korakom boste dodali eno 200-mikrogramsko tableto jutranjemu odmerku in še eno
The clinical status of the patient and the adverse reaction profile of selexipag (such as headache or hypotension) should be kept in mind when considering the patient's ability to drive and use machines.
Pri presoji bolnikove sposobnosti za vožnjo in upravljanje s stroji je treba upoštevati klinični status bolnika in profil neželenih učinkov seleksipaga (kot sta glavobol, hipotenzija).
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What you need to know before you take Uptravi
Kaj morate vedeti, preden boste vzeli zdravilo Uptravi Ne jemljite zdravila Uptravi
If, for any reason, you stop taking Uptravi for more than 3 consecutive days (if you missed 6 doses in a row), contact your PAH doctor or nurse immediately as your dose may need to be adjusted to avoid side effects.
6 odmerkov zaporedoma), se takoj obrnite na svojega zdravnika ali medicinsko sestro za PAH, saj je treba vaš odmerek morda prilagoditi, da se preprečijo neželeni učinki.
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Talk to your PAH doctor or nurse if you are taking any of the following medicines: - Gemfibrozil (medicine used to lower the level of fats [lipids] in the blood) - Clopidogrel (medicine used to inhibit blood clots in coronary artery disease) - Deferasirox (medicine used to remove iron from the blood stream) - Teriflunomide (medicine used to treat relapsing-remitting multiple sclerosis) - Carbamazepine (medicine used to treat some forms of epilepsy, nerve pain or to help control serious mood disorders when some other medicines do not work) - Phenytoin (medicine used to treat epilepsy) - Valproic acid (medicine used to treat epilepsy) - Probenecid (medicine used to treat gout) - Fluconazole, rifampicin or rifapentine (antibiotics used to treat infections)
- karbamazepin (zdravilo za zdravljenje nekaterih oblik epilepsije, bolečine živcev in za pomoč pri nadzoru resnih motenj razpoloženja, kadar nekatera druga zdravila ne delujejo) - fenitoin (zdravilo za zdravljenje epilepsije) - valprojska kislina (zdravilo za zdravljenje epilepsije) - probenecid (zdravilo za zdravljenje protina)
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During dose titration some adverse reactions, reflecting the mode of action of Uptravi (such as headache, diarrhoea, nausea and vomiting, jaw pain, myalgia, pain in extremity, arthralgia, and flushing), may occur.
Med titriranjem odmerka se lahko pojavijo nekateri neželeni učinki zaradi načina delovanja zdravila Uptravi (kot so glavobol, driska, navzea in bruhanje, bolečine v čeljustih, mialgija, bolečine v okončinah, artralgija in vročinski oblivi).
Only two subjects with severe (Child-Pugh class C) hepatic impairment were dosed with selexipag.
Odmerke seleksipaga sta prejeli le dve osebi z resno (razred C po Child-Pughu) okvaro jeter.
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The patient titration guide to be used by the healthcare professionals during discussions with the patient should contain the following key elements:
Navodilo za titriranje za bolnika uporabljajo zdravstveni delavci med pogovorom z bolnikom.
If a dose is missed, it should be taken as soon as possible.
Prekinitve in prenehanje Izpuščeni odmerek je treba dati takoj, ko je mogoče.
Hypromellose, propylene glycol, titanium dioxide (E171), carnauba wax and iron oxides (see below).
V filmski oblogi: hipromeloza, propilenglikol, titanov dioksid (E171), karnauba vosek in železovi oksidi (glejte spodaj).
Stepping down to a lower dose due to side effects
Zmanjševanje odmerka zaradi neželenih učinkov
In the presence of 400/100 mg lopinavir/ritonavir twice daily, a strong CYP3A4 inhibitor, exposure to selexipag increased approximately 2-fold, whereas the exposure to the active metabolite of selexipag did not change.
Zaviralci in induktorji CYP3A4 V prisotnosti 400 mg/100 mg lopinavirja/ritonavirja dvakrat na dan, močnega zaviralca CYP3A4, se je izpostavljenost seleksipagu povečala za približno 2-krat, medtem ko se izpostavljenost aktivnemu presnovku seleksipaga ni spremenila.
Hyperthyroidism Thyroid-stimulating Hormone decreased (see section 4.4)
Žilne bolezni vročinski oblivi* hipotenzija (glejte poglavje 4.4)
There are treatments available that can help relieve the side effects.
Za lajšanje neželenih učinkov so na voljo zdravila.
How should you take Uptravi?
Kako naj jemljem zdravilo Uptravi?
No adjustment to the dose regimen is needed in patients with mild hepatic impairment (Child-Pugh class A).
Režima odmerjanja pri bolnikih z blago okvaro jeter (razred A po Child-Pughu) ni treba prilagajati.
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The starting dose for Uptravi is 200 micrograms once in the morning and once in the evening.
200 mikrogramov enkrat zjutraj in enkrat zvečer.
Rash Urticaria Erythema
- anemija (nizka raven eritrocitov)
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A reduction (up to −0.3 MU/L from a baseline median of 2.5 MU/L) in median thyroid-stimulating hormone was observed at most visits in the selexipag group.
Pri večini obiskov so v skupini s seleksipagom opazili zmanjšanje (do −0,3 M e./l od izhodiščne mediane 2,5 M e./l) mediane ščitnico stimulirajočega hormona.
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Jaw pain* Myalgia* Arthralgia* Pain in extremity*
mialgija* artralgija*
Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease (see section 5.1).
povezano z boleznimi vezivnega tkiva, in PAH, povezano z zdravljeno preprosto prirojeno boleznijo srca (glejte poglavje 5.1).
Patients titrating selexipag to an individually tolerated dose (200 micrograms twice daily increments up to 800 micrograms twice daily; N = 33) achieved a statistically significant mean reduction in pulmonary vascular resistance of 30.3% (95% confidence interval [CI]: −44.7%, −12.2%; p = 0.0045) and an increase in cardiac index (mean treatment effect) of 0.48 L/min/m2 (95% CI: 0.13, 0.83) compared to placebo (N = 10).
(95-% interval zaupanja [IZ]: −44,7 %, −12,2 %; p = 0,0045) in povečanje srčnega indeksa (povprečni učinek zdravljenja) za 0,48 l/min/m2 (95-% IZ: 0,13; 0,83) v primerjavi s placebom (N = 10).
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Round, light-violet, film-coated tablets with “6” debossed on one side.
Okrogle, svetlo vijolične, filmsko obložene tablete, s "6" vtisnjeno na eni strani.
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