natgillin/translations-raw huggingface dataset:
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. 
Istodobna primjena lijeka Uptravi s klopidogrelom (udarna doza od 300 mg ili doza održavanja od 75 mg jednom dnevno), umjerenim inhibitorom CYP2C8, nije imala značajan utjecaj na izloženost seleksipagu, ali te je povećala izloženost aktivnom metabolitu oko 2,2 i 2,7 puta nakon udarne doze odnosno doze održavanja.
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. 
U ispitanika s blagim (Child-Pugh stadij A) ili umjerenim (Child-Pugh stadij B) oštećenjem funkcije jetre izloženost seleksipagu bila je 2 odnosno 4 puta veća, u usporedbi sa zdravim ispitanicima.
This is called titration. 
To se naziva titracija doze.
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 učinci povezani s titracijom i dozom održavanja Nuspojave povezane s načinom djelovanja seleksipaga uočene su često, posebice tijekom faze individualizirane titracije doze; navedene su u tablici ispod: Nuspojave koje nastaju zbog sličnosti s prostaciklinima
Your doctor may have you step up from the starting dose to higher doses of Uptravi. 
Vaš liječnik može Vam povećavati dozu Uptravija od početne doze prema većima.
With each step, you will add one 200 microgram tablet to your morning dose and another 200 microgram tablet to your evening dose. 
Sa svakim korakom, dodat ćete jednu tabletu od 200 mikrograma svojoj jutarnjoj dozi i još jednu tabletu od 200 mikrograma svojoj večernjoj dozi.
Do not stop taking Uptravi unless your doctor or nurse tells you to. 
Ako prestanete uzimati Uptravi Nemojte prekidati uzimanje Uptravija ukoliko Vam to ne kaže liječnik ili medicinska sestra.
60 or 140 film-coated tablets Titration pack 
60 ili 140 filmom obloženih tableta Pakiranje za titraciju doze
If you forget to take Uptravi.....................................16 If you stop taking Uptravi.........................................17 Titration diary...........................................................18 
Ako prestanete uzimati Uptravi .............................17
There are treatments available that can help relieve the side effects. 
Postoje dostupni lijekovi koji mogu pomoći olakšati nuspojave.
(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) % bolesnika s događajem u 36 mjeseci = 100 × (1 - Kaplan-Meier procjena); omjer hazarda procijenjen Coxovim modelom proporcionalnog hazarda; jednostrana p-vrijednost dobivena nestratificiranim log-rank testom (b) % bolesnika s događajem kao dijelom primarne mjere ishoda do EOT + 7 dana; omjer hazarda procijenjen AalenJohansenovom metodom; dvostrana p-vrijednost dobivena Grayevim testom
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 
U ispitivanoj populaciji etiološki je najčešći bio idiopatski ili nasljedni PAH (58%), zatim PAH zbog bolesti vezivnog tkiva (29%) PAH povezan s korigiranom jednostavnom prirođenom srčanom manom
Over time, your doctor or nurse may adjust your maintenance dose as needed. 
Vaš liječnik ili medicinska sestra može prilagoditi Vašu dozu održavanja prema potrebi.
Decreased appetite Weight decrease 
Poremećaji metabolizma i prehrane smanjen apetit smanjenje težine
Only two subjects with severe (Child-Pugh class C) hepatic impairment were dosed with selexipag. 
Samo su dva ispitanika s teškim (Child-Pugh stadij C) oštećenjem funkcije jetre primala seleksipag.
Mannitol (E421), maize starch, low substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate. 
Manitol (E421), kukuruzni škrob, djelomično supstituirana hidroksipropilceluloza, hidroksipropilceluloza, magnezijev stearat.
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 zbog PAH-a kao komponenta mjere ishoda zabilježena je u 16 (2,8%) bolesnika koji su primali seleksipag i 14 (2,4%) bolesnika koji su primali placebo.
The glucuronidation of the active metabolite is catalysed by UGT1A3 and UGT2B7. 
Glukuronidaciju aktivnog metabolita kataliziraju UGT1A3 i UGT2B7.
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. 
Ako ima manje od 6 sati do vremena kad biste obično uzeli sljedeću dozu, trebate preskočiti zaboravljenu dozu i nastaviti uzimati svoj lijek u uobičajeno vrijeme.
Selexipag is rapidly absorbed and is hydrolysed by carboxylesterases to its active metabolite. 
Apsorpcija Seleksipag se brzo apsorbira i hidrolizira putem karboksilesteraza u svoj aktivni metabolit.
Your doctor or nurse can prescribe an equivalent single-tablet strength for your maintenance dose. 
Vaš Vam liječnik ili medicinska sestra može propisati odgovarajuću jačinu u jednoj tableti za dozu održavanja.
The patients will receive an identical titration guide and Patient Leaflet in their titration packs of Uptravi. 
Isti takav vodič za titraciju i uputu o lijeku bolesnici će dobiti u svom pakiranju za titraciju doze
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. 
Ako je uskoro vrijeme za Vašu sljedeću dozu (manje od 6 sati do redovnog uzimanja) preskočite zaboravljenu dozu i nastavite uzimati svoj lijek u uobičajeno vrijeme.
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Patients were randomised to either placebo (N = 582) or selexipag (N = 574) twice daily. 
Bolesnici su bili randomizirani kako bi primali placebo (N = 582) ili seleksipag
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. 
Ako bolesnik ne podnosi terapiju u danoj dozi, treba razmotriti liječenje simptoma i/ili smanjenje doze na sljedeću nižu dozu.
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. 
U prisutnosti 600 mg rifampicina, jedanput dnevno, induktora CYP2C8 (i UGT enzima), izloženost seleksipagu nije se promijenila, dok se izloženost aktivnom metabolitu smanjila za pola.
There is limited experience with abrupt discontinuation of Uptravi in patients with PAH. 
Iskustvo s naglim prekidanjem uzimanja Uptravija u bolesnika s PAH-om je ograničeno.
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. 
U placebom kontroliranom ispitivanju faze 3 u bolesnika s PAH-om uočen je prolazan porast srednje vrijednosti frekvencije srca od 3-4 otkucaja/minuti 2-4 sata poslije uzimanja doze.
Dosage Adjustment with Co-administration of Moderate CYP2C8 Inhibitors 
Prilagodba doze uz istodobnu primjenu umjerenih inhibitora CYP2C8
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) 
- Teriflunomid (lijek koji se primjenjuje za liječenje relapsno-remitirajuće multiple skleroze) - Karbamazepin (lijek koji se primjenjuje za liječenje nekih oblika epilepsije, bol u živčanom sustavu ili za kontrolu ozbiljnih poremećaja raspoloženja kada neki drugi lijekovi ne djeluju) - Fenitoin (lijek koji se primjenjuje za liječenje epilepsije) - Valproatnu kiselinu (lijek koji se primjenjuje za liječenje epilepsije) - Probenecid (lijek koji se primjenjuje za liječenje gihta) - Flukonazol, rifampicin ili rifapentin (antibiotici koji se koriste za liječenje infekcija)
Your doctor may step you down to a lower dose. 
Vaš liječnik može Vam smanjiti dozu.
The active metabolite is a weak substrate of the breast cancer resistance protein (BCRP). 
Aktivni metabolit je slabi supstrat za protein koji uzrokuje rezistenciju raka dojke na lijekove
Treatment with selexipag resulted in a placebo-corrected median effect on 6MWD measured at trough (i.e., approximately 12 h post-dose) of 12 m at Week 26 (99% CI: 1, 24 m; 
Liječenje seleksipagom dovelo je do učinka na vrijednost medijana 6MTH korigiranu u odnosu na placebo, mjerenu na kraju doznog intervala (npr. približno 12 sati nakon uzimanja doze) za 12 m u 26. tjednu (99% CI: 1, 24 m; jednostrana p-vrijednost = 0,0027).
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CI = confidence interval; EOT = end of treatment; HR = hazard ratio; i.v. 
CI = interval pouzdanosti; EOT = završetak liječenja (od engl. end of treatment); HR = omjer hazarda; i.v. = intravenski; PAH = plućna arterijska hipertenzija; s.c. = supkutano.
More subjects reported adverse events after administration in the fasted than in the fed state. 
Više ispitanika prijavilo je nuspojave nakon uzimanja lijeka natašte nego nakon uzimanja u sitom stanju.
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. 
Ako se liječenje tijekom vremena slabije podnosi pri danoj dozi, treba razmotriti simptomatsko liječenje i/ili smanjenje doze na prethodnu manju dozu.
Selexipag and its main metabolite showed 20- to 80-times lower prostacyclin (IP) receptor potency in vitro for animal species used in reproductive toxicity testing compared to humans. 
do 80 puta manju potentnost prostaciklinskih (IP) receptora u životinjskih vrsta na kojima je ispitana reproduktivna toksičnost u usporedbi s ljudima.
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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. 
Broj smrtnih slučajeva zbog PAH-a do završetka ispitivanja bio je 70 (12,2%) u skupini koja je primala seleksipag i 83 (14,3%) u skupini koja je primala placebo.
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). 
Tijekom titracije doze, mogu Vam se javiti nuspojave kao što su glavobolja, proljev, mučnina, povraćanje, bol u čeljusti, bol u mišićima, bol u nogama, bol u zglobovima ili crvenilo lica (pogledajte dio 4.).
If you miss a dose, take the dose as soon as you remember, then continue to take your tablets at the usual times. 
Ako zaboravite uzeti dozu, uzmite ju čim se sjetite, a potom nastavite uzimati svoje tablete u uobičajeno vrijeme.
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. 
U prisutnosti 600 mg gemfibrozila, dva puta dnevno, jakog inhibitora CYP2C8, izloženost seleksipagu povećala se približno dvostruko, dok se izloženost aktivnom metabolitu, koji ima glavni doprinos djelotvornosti, povećala približno 11 puta.
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Thyroid function tests are recommended as clinically indicated in the presence of signs or symptoms of hyperthyroidism. 
U slučaju pojave znakova ili simptoma hipertireoze preporučuje se učiniti testove funkcije štitnjače prema kliničkim indikacijama.
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). 
(procijenjena brzina glomerularne filtracije [eGFR] < 30 ml/min/1,73 m2); titraciju doze u ovih bolesnika treba provoditi oprezno (vidjeti dio 4.4).
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. 
Uptravi se primjenjuje za dugotrajno liječenje plućne arterijske hipertenzije (PAH-a) u odraslih bolesnika u kojih bolest nije dovoljno kontrolirana drugim vrstama lijekova za PAH poznatih kao antagonisti endotelinskih receptora i inhibitori fosfodiesteraze tipa 5. Uptravi se može primjenjivati i sam u bolesnika koji nisu pogodni za liječenje ovim lijekovima.
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. 
Medijan 6MTH na početku ispitivanja bio je 376 m (raspon: 90-482 m) u bolesnika koji su primali seleksipag odnosno 369 m
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). 
Individualizirana titracija doze Svakom bolesniku treba polako povećavati dozu do najveće doze koju može podnositi, što može biti u rasponu od 200 mikrograma uzeto dva puta dnevno do 1600 mikrograma uzeto dva puta dnevno (individualizirana doza održavanja).
Abdominal pain 
bol u abdomenu
• Lay language version of the healthcare professional A4 laminated titration guide; 
• Inačicu vodiča za titraciju doze za zdravstvenog radnika na plastificiranom kartonu A4 formata pisanu laičkim jezikom;
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). 
U ispitivanju QT intervala na zdravim ispitanicima, ponovljene doze od 800 i 1600 mikrograma seleksipaga dva puta dnevno nisu pokazale učinak na repolarizaciju srca (QTc interval) ili provođenje (PR i QRS intervali), a imale su blagi utjecaj na povećanje frekvencije srca (porast frekvencije, korigiran u odnosu na placebo i prilagođen početnim vrijednostima, dosegao je 6-7 otkucaja/minuti
Disease progression b n (%) 
Progresija bolesti b n (%) i.v./s.c.
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The dose was increased at weekly intervals by increments of 200 micrograms given twice daily to determine the individualised maintenance dose (200-1,600 micrograms twice daily). 
200 mikrograma davan dva puta dnevno kako bi se odredila individualizirana doza održavanja (200-1600 mikrograma dva puta dnevno).
Dosing frequency of Uptravi should be reverted to twice daily when co-administration of moderate CYP2C8 inhibitor is stopped (see section 4.2). 
Učestalost doziranja lijeka Uptravi treba vratiti na dvaput dnevno nakon prekida istodobne primjene umjerenog inhibitora CYP2C8 (vidjeti dio 4.2).
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Treatment comparison: selexipag vs placebo 
Bolesnici s događajem Usporedba liječenja: seleksipag u odnosu na placebo
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• Healthcare professional A4 laminated titration guide; 
• Vodič za titraciju doze za zdravstvenog radnika na plastificiranom kartonu A4 formata; • Vodič za titraciju doze za bolesnika;
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. 
Tijekom titracije doze mogu se javiti neke nuspojave zbog načina djelovanja Uptravija (kao što su glavobolja, proljev, mučnina i povraćanje, bol u čeljusti, mialgija, bol u ekstremitetima, artralgija i crvenilo uz osjećaj vrućine).
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Uptravi film-coated tablets selexipag 
Uptravi filmom obložene tablete seleksipag
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Revert to twice daily dosing frequency of Uptravi when co-administration of moderate CYP2C8 inhibitor is stopped (see section 4.5). 
Primjenu lijeka Uptravi vratite na dvaput dnevno nakon prekida istodobne primjene umjerenog inhibitora CYP2C8 (vidjeti dio 4.5).
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Read the package leaflet and titration guide before use. 
NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku i vodič za titraciju.
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Each film-coated tablet contains 200 micrograms of selexipag 
Svaka filmom obložena tableta sadrži 200 mikrograma seleksipaga
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Maximum observed plasma concentrations of selexipag and its active metabolite after oral administration are reached within 1-3 h and 3-4 h, respectively. 
Najveće uočene koncentracije seleksipaga i njegovog aktivnog metabolita u plazmi nakon peroralne primjene bile su dosegnute unutar 1-3 sata za seleksipag odnosno 3-4 sata za njegov aktivni metabolit.
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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. 
Pri primjeni 400/100 mg lopinavira/ritonavira, jakog inhibitora CYP3A4, dva puta dnevno, izloženost seleksipagu povećala se približno dvostruko, dok se izloženost aktivnom metabolitu seleksipaga nije mijenjala.
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Concomitant administration of Uptravi with strong inhibitors of CYP2C8 (e.g., gemfibrozil) is contraindicated (see section 4.3). 
CYP2C8 (npr. gemfibrozil) je kontraindicirana (vidjeti dio 4.3).
The numerical increase in deaths up to end of treatment + 7 days but not up to study closure was further investigated by mathematical modelling, showing that the imbalance in deaths is consistent with the assumption of a neutral effect on PAH mortality and reduction of non-fatal events. 
dalje je ispitivan matematičkim modeliranjem te se pokazalo da je nesklad u smrtnim ishodima u skladu s pretpostavkom izostanka utjecaja na mortalitet od PAH-a i smanjenjem učestalosti događaja koji nemaju smrtni ishod.
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. 
(VWF) u plazmi; vrijednosti VWF zadržale su se iznad donje granice normalnog raspona.
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Uncommon side effects (may affect up to 1 in 100 people) - Increased heart rate 
Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) - glavobolja
Exposure to selexipag and the active metabolite at steady state in PAH patients and healthy subjects was similar. 
Izloženost seleksipagu i aktivnom metabolitu u stanju dinamičke ravnoteže bila je slična u bolesnika s
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Pulmonary haemodynamics 
Plućna hemodinamika
The most commonly reported adverse reactions are headache, diarrhoea, nausea and vomiting, jaw pain, myalgia, pain in extremity, arthralgia, and flushing. 
Najčešće zabilježene nuspojave su glavobolja, proljev, mučnina i povraćanje, bol u čeljusti, mialgija,
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Selexipag is hydrolysed to its active metabolite in the liver and in the intestine by carboxylesterases. 
Seleksipag se hidrolizira u jetri i crijevima putem karboksilesteraza u aktivni metabolit.
Talk to your doctor or nurse if you have side effects. 
Obratite se svom liječniku za PAH ili medicinskoj sestri prije nego uzmete Uptravi ako
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Cases of pulmonary oedema have been reported with vasodilators (mainly prostacyclins) when used in patients with pulmonary veno-occlusive disease. 
Pri primjeni vazodilatatora (uglavnom prostaciklina) u bolesnika s plućnom venookluzivnom bolesti prijavljeni su slučajevi plućnog edema.
Efficacy in patients with PAH 
Lijekovi za PAH
Uptravi 200 microgram Uptravi 400 microgram Uptravi 600 microgram Uptravi 800 microgram Uptravi 1,000 microgram Uptravi 1,200 microgram Uptravi 1,400 microgram Uptravi 1,600 microgram 
Uptravi 600 mikrograma Uptravi 800 mikrograma Uptravi 1000 mikrograma Uptravi 1200 mikrograma Uptravi 1400 mikrograma Uptravi 1600 mikrograma
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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. 
Organisation functional class), ili kao dio kombiniranog liječenja u bolesnika u kojih bolest nije dovoljno kontrolirana antagonistom endotelinskih receptora (ERA-om, engl. endothelin receptor antagonist) i/ili inhibitorom fosfodiesteraze tipa 5 (PDE-5), ili kao monoterapija u bolesnika koji nisu pogodni za prethodno navedene terapije.
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%). 
ERA-ima (15%) ili inhibitorima PDE-5 (32%) ili kombinacijom ERA-a i inhibitora PDE-5 (33%).
Uptravi 400 microgram, 600 microgram, 800 microgram, 1,000 microgram, 1,200 microgram, 1,400 microgram, and 1,600 microgram film-coated tablets Cartons of 60 film-coated tablets. 
Uptravi 400 mikrograma, 600 mikrograma, 800 mikrograma, 1000 mikrograma, 1200 mikrograma, 1400 mikrograma, i 1600 mikrograma filmom obložene tablete Kutije sa 60 filmom obloženih tableta.
Sinus tachycardia 
Srčani poremećaji sinusna tahikardija