FrancophonIA/ELRC3.0 huggingface dataset:
English: Uptravi is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Ne preporučuje se koristiti lijek Uptravi tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste kontracepciju.
English: Death up to EOT + 7 daysd n (%)
Croatian: Smrt do EOT + 7 danad n (%)
English: Endpoints & statistics
Croatian: Mjere ishoda i statistika
English: Selectivity against EP1, EP3, FP, and TP is important because these are well-described contractile receptors in the gastro-intestinal tract and blood vessels.
Croatian: Selektivnost prema EP1, EP3, FP i TP je važna jer su to dobro poznati receptori koji posreduju signal za kontrakcije u gastrointestinalnom sustavu i krvnim žilama.
English: Tell your doctor if you are taking other medications as your doctor may recommend that you take Uptravi only once daily.
Croatian: Recite svom liječniku ako uzimate druge lijekove, jer Vaš liječnik može preporučiti da lijek Uptravi uzimate samo jednom dnevno.
English: At the beginning of treatment and at each up-titration step it is recommended to take the first dose in the evening.
Croatian: Na početku liječenja i pri svakom koraku povećanja doze, preporučuje se prvu dozu uzeti navečer.
English: Effect of other medicinal products on selexipag
Croatian: Učinak drugih lijekova na seleksipag
English: If you stop taking Uptravi
Croatian: Ako prestanete uzimati Uptravi
English: It acts on blood vessels in a similar way to the natural substance prostacyclin, making them relax and widen.
Croatian: On djeluje na krvne žile na sličan način kao prirodna tvar prostaciklin, uzrokujući njihovo opuštanje i širenje.
English: Uptravi is not recommended during pregnancy and breast-feeding.
Croatian: Uptravi se ne preporučuje tijekom trudnoće i dojenja.
English: If your titration steps last longer than 1 week there are additional diary pages to track this.
Croatian: Ukoliko korak titracije traje dulje od 1 tjedna, postoje dodatne stranice u dnevniku za praćenje.
English: Do not split, crush or chew the tablets.
Croatian: Tablete nemojte lomiti, zdrobiti ili žvakati.
English: The cover letter to the healthcare professional should explain that the purpose of the educational materials is to reduce the risk of medication error due to the availability of multiple tablets and dose strengths, and it should provide a list of the contents of the Prescriber Kit.
Croatian: Popratno pismo za zdravstvenog radnika treba objasniti da je svrha edukacijskih materijala smanjenje rizika od medikacijske pogreške zbog dostupnosti različitih tableta i jačina doze te sadržavati popis sadržaja Kompleta.
English: Hyperthyroidism has been observed with Uptravi.
Croatian: Hipertireoza je zabilježena uz Uptravi.
English: Selexipag prevents cardiac and pulmonary remodelling in a rat model of PAH and causes proportional decreases in pulmonary and peripheral pressures, indicating that peripheral vasodilation reflects pulmonary pharmacodynamic efficacy.
Croatian: Seleksipag sprečava remodeliranje srca i pluća na štakorskom modelu PAH-a i uzrokuje proporcionalno smanjenje plućnih i perifernih tlakova, upućujući na zaključak da periferna vazodilatacija odražava plućne farmakodinamičke učinke.
English: If treatment is missed for 3 days or more, Uptravi should be restarted at a lower dose and then up-titrated.
Croatian: Ako se liječenje propusti tijekom 3 ili više dana, Uptravi treba ponovno uvesti s nižom dozom i zatim ju povećavati.
English: This is most probably due to a first-pass effect of selexipag, as plasma concentrations of the active metabolite are similar after the same oral and intravenous dose administration.
Croatian: To je najvjerojatnije zbog učinka prvog prolaska seleksipaga jer su koncentracije aktivnog metabolita u plazmi slične nakon peroralne i intravenske primjene jednake doze.
English: Patients who have poor vision or are blind must be instructed to get assistance from another person when taking Uptravi during the titration period.
Croatian: Bolesnike koji slabo vide ili su slijepi treba uputiti da zatraže pomoć od druge osobe pri uzimanju
English: Once your doctor has found the dose that is right for you, this will be the dose you take on a regular basis.
Croatian: Kad Vaš liječnik odredi pravu dozu za Vas, to će biti doza koju trebate redovno uzimati.
English: There is no experience with Uptravi in patients undergoing dialysis (see section 5.2), therefore Uptravi should not be used in these patients.
Croatian: Nema iskustva s primjenom Uptravija u bolesnika na dijalizi (vidjeti dio 5.2), stoga se Uptravi ne treba primjenjivati u tih bolesnika.
English: When you move to your maintenance dose
Croatian: Kad prelazite na dozu održavanja
English: Do not stop taking Uptravi unless your doctor tells you to.
Croatian: Nemojte prekidati uzimanje Uptravija ukoliko Vam to ne kaže liječnik.
English: Mechanistically, the effect is considered to be induced by life-long vasodilation and subsequent changes in ocular haemodynamics.
Croatian: Mehanicistički, smatra se da je učinak izazvan cjeloživotnom vazodilatacijom i posljedičnim promjenama hemodinamike oka.
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.
Croatian: Izlučivanje je u zdravih ispitanika bilo potpuno 5 dana nakon primjene i odvijalo se primarno putem fecesa (što odgovara 93% primjenjene doze) u usporedbi s 12% putem urina.
English: There was no significant treatment effect from baseline to Week 26.
Croatian: Nije bilo značajnog učinka liječenja od početka ispitivanja do 26. tjedna.
English: What Uptravi looks like and contents of the pack
Croatian: Kako Uptravi izgleda i sadržaj pakiranja
English: Stimulation of the IP receptor by selexipag and the active metabolite leads to vasodilatory as well as anti-proliferative and anti-fibrotic effects.
Croatian: Stimulacija IP receptora seleksipagom i aktivnim metabolitom dovodi do vazodilatacijskih kao i antiproliferativnih i antifibrotičnih učinaka.
English: If these side effects are difficult for you to tolerate, talk to your doctor about how to manage or treat them.
Croatian: Ako Vam je teško podnijeti te nuspojave, razgovarajte sa svojim liječnikom o tome kako ih zbrinuti ili liječiti.
English: The beneficial effect of selexipag was primarily attributable to a reduction in hospitalisation for PAH and a reduction in other disease-progression events (Table 1).
Croatian: Koristan učinak seleksipaga bio je primarno pripisiv smanjenju udjela hospitalizacija zbog PAH-a i smanjenju udjela drugih događaja koji upućuju na progresiju bolesti (Tablica 1).
English: The patient titration guide to be used by the healthcare professionals during discussions with the patient should contain the following key elements:
Croatian: Vodič za titraciju doze za bolesnika koji će zdravstveni radnik koristiti tijekom razgovora s bolesnikom treba sadržavati sljedeće ključne elemente:
English: There are no data from the use of selexipag in pregnant women.
Croatian: Nema podataka o primjeni seleksipaga u trudnica.
English: Because of the species-specific sensitivity of dogs to develop intussusception, this finding is considered not relevant for adult humans.
Croatian: Budući da su psi kao vrsta osjetljivi na razvoj intususcepcije, taj se nalaz ne smatra značajnim za odrasle ljude.
English: Do not take Uptravi
Croatian: Nemojte uzimati Uptravi
English: Your doctor will instruct you to gradually increase your dose.
Croatian: Vaš će Vas liječnik uputiti da si postupno povećavate dozu.
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.
Croatian: Budući da se ljudski EP4 receptori ne aktiviraju seleksipagom ni njegovim aktivnim metabolitom, ovi su učinci specifični za vrstu te stoga nisu značajni za ljude.
English: Additional histopathological findings of selexipag were observed only at exposures sufficiently in excess of the maximum human exposure, indicating little relevance to humans.
Croatian: Dodatni histopatološki nalazi djelovanja seleksipaga uočeni su samo pri izloženostima koje su znatno veće od najveće izloženosti u ljudi, upućujući na malen značaj za ljude.
English: Otherwise, fertility parameters were not affected.
Croatian: Nije bilo utjecaja na ostale parametre plodnosti.
English: Inhibitors and inducers of CYP3A4
Croatian: Inhibitori i induktori CYP3A4
English: Therefore, safety margins for potential IP receptor-mediated effects on reproduction are accordingly lower than for non-IP-related effects (see section 5.3).
Croatian: Stoga su granice sigurnosti za moguće učinke na reprodukciju posredovane IP receptorima sukladno manje nego za učinke koji nisu povezani s djelovanjem na IP receptore (vidjeti dio 5.3).
English: Since a strong inhibitor of CYP3A4 did not affect the pharmacokinetics of the active metabolite, indicating that the CYP3A4 pathway is not important in the elimination of the active metabolite, no effect of inducers of CYP3A4 on the pharmacokinetics of the active metabolite is expected.
Croatian: Budući da jaki inhibitor CYP3A4 nije utjecao na farmakokinetiku aktivnog metabolita, upućujući na zaključak da put CYP3A4 nije važan za eliminaciju aktivnog metabolita, ne očekuje se utjecaj induktora CYP3A4 na farmakokinetiku aktivnog metabolita.
English: - The active substance is selexipag.
Croatian: - Djelatna tvar je seleksipag.
English: If you experience any of these side effects: headache, diarrhoea, feeling sick (nausea), being sick (vomiting), jaw pain, muscle pain, leg pain, joint pain, or reddening of the face, that you cannot tolerate or that cannot be treated, you should contact your doctor as the dose you are taking maybe too high for you and may need to be reduced.
Croatian: Ako osjetite bilo koju od ovih nuspojava: glavobolja, proljev, mučnina, povraćanje, bol u čeljusti, bol u mišićima, bol u nogama, bol u zglobovima ili crvenilo lica, koju ne možete podnositi ili se ne može liječiti, trebate se javiti svom liječniku jer je doza koji uzimate možda prevelika za Vas i možda se mora smanjiti.
English: The following diary pages help you keep track of the number of tablets you need to take in the morning and evening during titration.
Croatian: Sljedeće stranice dnevnika pomažu Vam pratiti broj tableta koji trebate uzeti ujutro i navečer tijekom titracije.
English: How should you take Uptravi?
Croatian: Kako trebate uzimati Uptravi?
English: In the 2-year carcinogenicity studies, selexipag caused an increased incidence of thyroid adenomas in mice and Leydig cell adenomas in rats.
Croatian: U dvogodišnjim ispitivanjima kancerogenosti seleksipag je uzrokovao povećanu učestalost adenoma štitnjače u miševa i adenoma Leydigovih stanica u štakora.
English: Suddenly stopping your treatment with Uptravi might lead to your symptoms getting worse.
Croatian: Nagli prekid liječenja Uptravijem može dovesti do pogoršanja simptoma.
English: These effects are usually transient or manageable with symptomatic treatment.
Croatian: Ove nuspojave su obično prolazne ili se mogu zbrinuti simptomatskim liječenjem.
English: This may cause people to feel tired, dizzy, short of breath, or experience other symptoms.
Croatian: To u osoba može uzrokovati osjećaj umora, omaglicu, otežano disanje ili pojavu drugih simptoma.
English: Jaw pain* Myalgia* Arthralgia* Pain in extremity*
Croatian: mialgija* artralgija* bol u ekstremitetima*
English: Like all medicines, Uptravi can cause side effects.
Croatian: Kao i svi lijekovi, Uptravi može uzrokovati nuspojave.
English: The first intake of Uptravi should be in the evening.
Croatian: Prvo uzimanje Uptravija treba biti navečer.
English: Prostanoid initiation or oxygen therapy b c n (%)
Croatian: Uvođenje prostanoida ili terapija kisikom b c n (%)
English: It lets your body adjust to the new medicine.
Croatian: Na taj se način dopušta tijelu da se prilagodi novom lijeku.
English: You should only step down after speaking with your PAH doctor or nurse.
Croatian: Dozu trebate smanjiti samo nakon razgovora sa svojim liječnikom za PAH ili medicinskom sestrom.
English: There is limited clinical experience in patients over the age of 75 years, therefore Uptravi should be used with caution in this population (see section 4.4).
Croatian: Kliničko iskustvo s bolesnicima starijim od 75 godina je ograničeno te se stoga Uptravi u ovoj populaciji treba koristiti oprezno (vidjeti dio 4.4).
English: In the rat pre-/post-natal development study, selexipag induced no effects on maternal and pup reproductive function.
Croatian: U ispitivanjima prenatalnog/postnatalnog razvoja u štakora seleksipag nije imao učinka na reproduktivne funkcije majke i mladunčadi.
English: Some patients may have 200 micrograms in the morning and in the evening as their maintenance dose, while some will reach the highest dose of 1,600 micrograms in the morning and in the evening.
Croatian: Neki bolesnici mogu imati dozu od 200 mikrograma ujutro i navečer kao svoju dozu održavanja, dok će neki dosegnuti najveću dozu od 1600 mikrograma ujutro i navečer.
English: The diagram below shows the number of tablets to take every morning and every evening at each step, starting with step 5.
Croatian: Shema ispod pokazuje broj tableta koji treba uzeti svakog jutra i svake večeri za svaki korak, počevši od 5. koraka.
English: In the presence of food, the exposure to selexipag after a single dose of 400 micrograms was increased by 10% in Caucasian subjects and decreased by 15% in Japanese subjects, whereas exposure to the active metabolite was decreased by 27% (Caucasian subjects) and 12% (Japanese subjects).
Croatian: U slučaju uzimanja uz hranu izloženost seleksipagu nakon jednokratne doze od 400 mikrograma porasla je za 10% u ispitanika bijelaca, a smanjila se za 15% u ispitanika Japanaca, dok se izloženost aktivnom metabolitu smanjila za 27% (ispitanici bijelci) i 12% (ispitanici Japanci).
English: Your doctor may tell you to reduce the dose gradually before stopping completely.
Croatian: Vaš liječnik može Vas uputiti da postupno smanjujete dozu prije nego ga potpuno prestanete uzimati.
English: If the side effects cannot be treated or do not gradually get better on the dose you are taking, your doctor may adjust your dose by reducing the number of 200 microgram light-yellow tablets you take by one in the morning and by one in the evening.
Croatian: Ako se nuspojave ne mogu liječiti ili se postupno ne poboljšaju uz dozu koju uzimate, Vaš liječnik može prilagoditi dozu smanjivanjem broja svijetlo žutih tableta od 200 mikrograma koje uzimate za jednu ujutro i za jednu navečer.
English: These reactions are more frequent during the up-titration phase.
Croatian: Te su reakcije češće tijekom faze povećavanja doze.
English: Uptravi should only be prescribed by a doctor experienced in the treatment of PAH.
Croatian: Uptravi smije propisati samo liječnik s iskustvom u liječenju PAH-a.
English: Hospitalisation due to PAH b n (%)
Croatian: Hospitalizacija zbog PAH-a b n (%)
English: If your side effects are manageable after stepping down your dose, your doctor may decide that you should stay on that dose.
Croatian: Ako se nuspojave mogu zbrinuti nakon smanjenja doze, Vaš liječnik može odlučiti da trebate nastaviti uzimati tu dozu.
English: In rats, selexipag or its metabolites are excreted in milk (see section 5.3).
Croatian: U štakora se seleksipag i njegovi metaboliti izlučuju u mlijeko (vidjeti dio 5.3).
English: 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.
Croatian: Farmakokinetika seleksipaga i aktivnog metabolita u bolesnika s PAHom nije bila pod utjecajem težine bolesti i nije se mijenjala s vremenom.
English: Selexipag did not influence the pharmacodynamic effect of warfarin on the international normalised ratio.
Croatian: Seleksipag nije utjecao na farmakodinamički učinak varfarina na međunarodno normalizirani omjer.
English: Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH.
Croatian: Liječenje treba započeti i nadzirati samo liječnik s iskustvom u liječenju PAH-a.
English: Selexipag is a weak substrate of the P-gp efflux pump.
Croatian: Seleksipag je slabi supstrat za P-gp efluksnu crpku.
English: This allows you to take one tablet in the morning and one in the evening, instead of multiple tablets each time.
Croatian: To Vam omogućuje da uzimate jednu tabletu ujutro i jednu navečer, umjesto da svaki put uzimate više tableta.
English: As with all medicines, you may experience side effects with Uptravi as you step up to higher doses.
Croatian: Kao i uz sve lijekove, uz Uptravi se mogu javiti nuspojave kako prelazite na veće doze.
English: Selexipag is a selective IP receptor agonist distinct from prostacyclin and its analogues.
Croatian: Seleksipag je selektivni agonist IP receptora različit od prostaciklina i njegovih analoga.
English: Over time, your doctor may adjust your maintenance dose as needed.
Croatian: Tijekom vremena liječnik može prilagoditi Vašu dozu održavanja prema potrebi.
English: Increased bone ossification and related changes in the bone marrow in dog studies are considered to be due to the activation of EP4 receptors in dogs.
Croatian: Smatra se da su pojačana osifikacija i s njom povezane promjene u koštanoj srži u ispitivanjima na psima posljedica aktivacije EP4 receptora u pasa.
English: What is important is that you reach the dose that is most appropriate to treat you.
Croatian: Važno je da Vi dosegnete dozu koja Vama najbolje odgovara za liječenje.
English: Selexipag does not cause IP receptor desensitisation in vitro nor tachyphylaxis in a rat model.
Croatian: Seleksipag ne uzrokuje desenzitizaciju IP receptora in vitro ni tahifilaksiju na štakorskom modelu.
English: 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).
Croatian: Djelotvornost je dokazana u populaciji s PAH-om uključujući idiopatski i nasljedni PAH, PAH povezan s poremećajima vezivnog tkiva i PAH povezan s korigiranom jednostavnom prirođenom srčanom manom (vidjeti dio 5.1).
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.
Croatian: Ako Vas liječnik uputi da produljite trajanje svakog koraka titracije dulje od jednog tjedna, dnevnik titracije sadrži dodatne stranice koje Vam omogućuju praćenje.
English: • Tracking of the receipt of the kits by prescribers.
Croatian: • Praćenje primitka Kompleta od strane propisivača.
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.
Croatian: To će biti najveća doza koju možete podnijeti, što može dosegnuti najveću dozu od 1600 mikrograma ujutro i navečer.
English: On the diary pages, check off that you have taken one 800 microgram tablet every day in the morning and in the evening with your prescribed number of 200 microgram tablets.
Croatian: Na stranicama dnevnika zabilježite da ste uzeli jednu tabletu od 800 mikrograma svakog dana ujutro i navečer zajedno s propisanim brojem tableta od 200 mikrograma.
English: By mimicking the action of prostacyclin, Uptravi widens the pulmonary arteries and reduces their hardening.
Croatian: Oponašajući djelovanje prostaciklina, Uptravi proširuje plućne arterije i smanjuje njihovu krutost.
English: Polyamide / aluminium / HDPE / PE with an embedded desiccant agent / HDPE blister sealed with an aluminium foil.
Croatian: Poliamid/aluminij/HDPE/PE s ugrađenim sredstvom za sušenje / HDPE blister zatvoren aluminijskom folijom.
English: In juvenile dogs, intussusception due to prostacyclin-related effects on intestinal motility was observed sporadically.
Croatian: U mladih pasa je sporadično uočena intususcepcija zbog učinaka povezanih s prostaciklinima na motilitet crijeva.
English: Exercise capacity was evaluated as a secondary endpoint.
Croatian: Simptomatske mjere ishoda Kapacitet vježbanja procijenjen je kao sekundarna mjera ishoda.
English: Prior to the launch of Uptravi in each Member State, the MAH must agree on the content and format of the Controlled Access System with the National Competent Authority.
Croatian: Uptravija na tržište svake države članice nositelj odobrenja mora se dogovoriti s nadležnim nacionalnim tijelom oko sadržaja i oblika kontroliranog sustava pristupa.
English: Selexipag was not teratogenic in rats and rabbits (exposure margins above therapeutic exposure of 13-fold for selexipag and 43-fold for the active metabolite, based on total exposure).
Croatian: Seleksipag nije pokazao teratogene učinke u štakora i kunića (granice izloženosti iznad izloženosti pri liječenju bile su 13 puta za seleksipag i 43 puta za aktivni metabolit, temeljeno na ukupnoj izloženosti).
English: Figure 1 Kaplan-Meier estimates of the first morbidity-mortality event
Croatian: Procjene prvog događaja morbiditeta/mortaliteta Kaplan-Meier metodom
English: To improve tolerability, it is recommended to take Uptravi with food and, at the beginning of each up-titration phase, to take the first increased dose in the evening.
Croatian: Kako bi se povećala tolerancija, preporučuje se Uptravi uzimati s hranom te prvu povećanu dozu na početku svake faze povećanja doze uzimati navečer.
English: If, at any time, after taking the same dose for a long time, you experience side effects that you cannot tolerate or side effects that have an impact on your normal daily activities, contact your doctor as your dose may need to be reduced.
Croatian: Ako Vam se u bilo kojem trenutku, nakon uzimanja iste doze dugo vremena, jave nuspojave koje ne možete podnijeti ili nuspojave koje utječu na Vaše uobičajene svakodnevne aktivnosti, obratite se svome liječniku jer
English: For example, if your highest tolerated dose during titration was 1,200 micrograms once in the morning and once in the evening:
Croatian: Na primjer, ako je najveća doza koju ste mogli podnijeti tijekom titracije bila 1200 mikrograma jednom ujutro i jednom navečer:
English: 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.
Croatian: Smanjenje (do −0,3 mU/l od početnog medijana od 2,5 mU/l) medijana razine hormona koji stimulira štitnjaču uočeno je na većini posjeta u skupini koja je primala seleksipag.
English: It is unknown whether selexipag or its metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se seleksipag ili njegovi metaboliti u majčino mlijeko.
English: In rat studies, selexipag at high doses caused transient disturbances in oestrus cycles that did not affect fertility (see section 5.3).
Croatian: U ispitivanjima na štakorima seleksipag je u visokim dozama uzrokovao prolazne poremećaje estrusnih ciklusa koji nisu utjecali na plodnost (vidjeti dio 5.3).
English: Tell your doctor if you experience side effects, as your doctor may recommend that you change your Uptravi dose.
Croatian: Recite svom liječniku ako Vam se jave nuspojave, jer Vaš liječnik može preporučiti da promijenite dozu lijeka Uptravi.
English: Electrocardiogram investigations showed sinus tachycardia in 11.3% of patients in the selexipag group compared to 8.8% in the placebo group (see section 5.1).
Croatian: Pretrage elektrokardiogramom pokazale su sinusnu tahikardiju u 11,3% bolesnika u skupini koja je primala seleksipag u usporedbi s 8,8% u skupini koja je primala placebo (vidjeti dio 5.1).
English: After multiple-dose administration, steady state conditions of selexipag and the active metabolite were reached within 3 days.
Croatian: Nakon višekratne primjene doze, uvjeti stanja dinamičke ravnoteže seleksipaga i aktivnog metabolita dosegnuti su unutar 3 dana.
English: Titration diary
Croatian: Dnevnik titracije
English: Concomitant administration of selexipag with CYP3A4 substrates does not require dose adjustment.
Croatian: Istodobna primjena seleksipaga i supstrata za CYP3A4 ne zahtijeva prilagodbu doze.