FrancophonIA/ELRC3.0 huggingface dataset:
English: Check with your doctor if you are not sure or have any questions.
Croatian: Provjerite s liječnikom ako niste sigurni ili imate kakvih pitanja.
English: The Controlled Access System should include three key principles that will be incorporated within each system in all Member States.
Croatian: Kontrolirani sustav pristupa mora uključivati tri ključna načela koja će se uključiti u svaki sustav u svim državama članicama.
English: The safety and efficacy of Uptravi in children aged 0 to less than 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost Uptravija u djece u dobi od 0 do 18 godina nisu još ustanovljene.
English: Absolute risk reduction
Croatian: Smanjenje apsolutnog rizika
English: What Uptravi is and what it is used for
Croatian: Što je Uptravi i za što se koristi
English: Paediatric population (< 18 years)
Croatian: Pedijatrijska populacija (< 18 godina)
English: However, not every patient will reach this dose, because different patients require different doses.
Croatian: Ipak, neće svaki bolesnik dosegnuti tu dozu, jer različiti bolesnici trebaju različite doze.
English: Every patient with PAH is different.
Croatian: Svaki bolesnik s PAH-om je drugačiji.
English: There are 2 phases of treatment with Uptravi:
Croatian: Postoje 2 faze liječenja Uptravijem:
English: • Myocardial infarction within the last 6 months.
Croatian: • Infarkt miokarda unutar zadnjih 6 mjeseci.
English: If you take more Uptravi than you should
Croatian: Ako uzmete više Uptravija nego što ste trebali
English: Do not give this medicine to children under 18 years of age, because Uptravi has not been tested in children.
Croatian: Ovaj lijek nemojte davati djeci mlađoj od 18 godina jer Uptravi nije ispitan u djece.
English: The majority of these reactions are of mild to moderate intensity.
Croatian: Većina tih reakcija je blagog do umjerenog intenziteta.
English: Each step usually lasts about 1 week.
Croatian: Svaki korak obično traje otprilike 1 tjedan.
English: Always take Uptravi exactly as your doctor has told you.
Croatian: Uvijek uzmite Uptravi točno onako kako Vam je rekao Vaš liječnik.
English: At the start of treatment, you will take the lowest dose.
Croatian: Na početku liječenja uzimat ćete najmanju dozu.
English: Read all of this leaflet carefully before taking this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži Vama važne podatke.
English: Relative risk reduction (99% CI)
Croatian: Smanjenje relativnog rizika (99% CI)
English: Each step usually lasts about 1 week, unless your doctor or nurse instructs you otherwise.
Croatian: Svaki korak obično traje otprilike 1 tjedan, ukoliko Vas liječnik ili medicinska sestra ne uputi drugačije.
English: Not everyone will end up on the same maintenance dose.
Croatian: Neće svatko imati istu dozu održavanja.
English: This process is called titration.
Croatian: Taj se proces naziva titracija.
English: If you have taken more tablets than you have been told to take, ask your doctor for advice.
Croatian: Ako ste uzeli više tableta nego što Vam je rečeno, obratite se liječniku za savjet.
English: You should take each dose with a glass of water, preferably during a meal.
Croatian: Svaku dozu trebate uzeti s čašom vode, naibolje tijekom obroka.
English: Swallow the tablets whole with a glass of water.
Croatian: Progutajte cijele tablete s čašom vode.
English: The exposure to selexipag was up to 4.2 years.
Croatian: Izloženost seleksipagu trajala je do 4,2 godine.
English: Contents of the package and other information
Croatian: Sadržaj pakiranja i druge informacije
English: The absolute bioavailability of selexipag in humans is approximately 49%.
Croatian: Apsolutna biodostupnost seleksipaga u ljudi iznosi približno 49%.
English: The missed dose should not be taken if the next scheduled dose is within approximately 6 hours.
Croatian: Propuštenu dozu ne treba uzeti ako je sljedeća planirana doza unutar približno 6 sati.
English: If you notice any of the above signs or your condition changes, tell your doctor immediately.
Croatian: Ako primijetite bilo koji od gore navedenih znakova ili Vam se stanje promijeni odmah obavijestite svog liječnika.
English: If a dose is missed, it should be taken as soon as possible.
Croatian: Ako se doza propusti, treba ju uzeti što je prije moguće.
English: Finding the right dose for you
Croatian: Pronalaženje prave doze za Vas
English: Other medicines and Uptravi
Croatian: Drugi lijekovi i Uptravi
English: However, if the decision to withdraw Uptravi is taken, it should be done gradually while an alternative therapy is introduced.
Croatian: Ipak, ukoliko se donese odluka o ukidanju Uptravija, to treba učiniti postupno uz istodobno uvođenje alternativnog liječenja.
English: What you need to know before you take Uptravi
Croatian: Što morate znati prije nego počnete uzimati Uptravi
English: The goal of titration is to reach the most appropriate dose.
Croatian: Cilj titracije je doseći najprikladniju dozu.
English: - if you are allergic to selexipag or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na seleksipag ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: For example, painkillers such as paracetamol may help treat pain and headache.
Croatian: Na primjer, lijekovi protiv bolova kao što je paracetamol mogu pomoći u liječenju boli i glavobolje.
English: Take the tablets with meals as you might tolerate your medicine better.
Croatian: Uzimajte tablete uz obrok jer tako možete bolje podnijeti lijek.
English: Transporter inhibitors (lopinavir/ritonavir)
Croatian: Inhibitori prijenosnika (lopinavir/ritonavir)
English: • Severe coronary heart disease or unstable angina.
Croatian: • Teška koronarna bolest srca ili nestabilna angina.
English: • Encouragement and guidance for healthcare professionals to communicate clearly with the patient during their first visit, as well as to take responsibility to contact the patient during the titration phase, facilitating communication between healthcare professional and the patient (need for contact and to schedule telephone calls).
Croatian: • Poticaj i smjernice zdravstvenim radnicima za jasnu komunikaciju s bolesnikom tijekom prvog posjeta, kao i za preuzimanje odgovornosti za održavanje kontakta s bolesnikom tijekom faze titracije, olakšavajući na taj način komunikaciju zdravstvenog radnika i bolesnika (potrebno je uzeti kontakt i dogovoriti telefonske pozive).
English: Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Remember to record the number of tablets you take every day in your titration diary.
Croatian: Sjetite se upisati broj tableta koje uzimate svaki dan u svoj dnevnik titracije.
English: In the placebo group, little change in median values was apparent.
Croatian: U skupini koja je primala placebo bile su vidljive male promjene vrijednosti medijana.
English: Your doctor will tell you to increase your dose in steps, usually every week but the interval between increases could be longer.
Croatian: Vaš će Vam liječnik reći da si povećavate dozu u koracima, obično svakog tjedna, no razdoblje između povećanja može biti i duže.
English: There are no clinical data available.
Croatian: Klinički podaci nisu dostupni.
English: How should you step up your dose?
Croatian: Kako si trebate povećavati dozu?
English: You may experience side effects not only during the titration period when your dose is being increased, but also later after taking the same dose for a long time.
Croatian: Nuspojave se mogu javiti ne samo za vrijeme razdoblja titracije doze kad Vam se povećava doza, nego također i kasnije nakon uzimanja iste doze dulje vrijeme.
English: Please remember to dispose of unused tablets (see section 5).
Croatian: Molimo Vas da se sjetite zbrinuti neiskorištene tablete (pogledajte dio 5.).
English: This is called the maintenance dose.
Croatian: To se zove doza održavanja.
English: Caucasian (65.0%) and female (79.8%).
Croatian: (65,0%) i ženskog spola (79,8%).
English: The Controlled Access System is aimed to facilitate the identification of prescribers, to approach them with the appropriate information on the safe and effective use of Uptravi, and to provide them with risk minimisation tools, especially regarding the potential risk of medication error.
Croatian: Cilj kontroliranog sustava pristupa je olakšati identifikaciju propisivača, pristupiti im s odgovarajućim informacijama o sigurnoj i djelotvornoj primjeni Uptravija te im omogućiti pristup sredstvima za minimizaciju rizika, posebice s obzirom na mogući rizik od medikacijske pogreške.
English: Specific drug-drug interaction studies with hormonal contraceptives have not been conducted.
Croatian: Hormonski kontraceptivi Specifična ispitivanja interakcija između lijekova s hormonskim kontraceptivima nisu provedena.
English: If you are a woman who can have children, you should use an effective contraceptive method while taking Uptravi.
Croatian: Ako ste žena koja može imati djecu, morate koristiti djelotvornu metodu kontracepcije za vrijeme uzimanja Uptravija.
English: The tablets should not be split, crushed or chewed, and are to be swallowed with water.
Croatian: Tablete se ne smiju lomiti, drobiti ili žvakati, te ih treba progutati s vodom.
English: Except for the active metabolite, none of the circulating metabolites in human plasma exceed 3% of the total drug-related material.
Croatian: Osim aktivnog metabolita, nijedan od metabolita koji cirkuliraju u ljudskoj plazmi ne prelazi udio od 3% od svih tvari povezanih s lijekom.
English: Do not take a double dose to make up for a forgotten tablet.
Croatian: Nemojte uzimati dvostruku dozu kako biste nadoknadili zaboravljenu tabletu.
English: 17.9% of patients were ≥ 65 and 1.1% ≥ 75 years of age.
Croatian: 17,9% bolesnika bilo je u dobi ≥ 65 te 1,1% ≥ 75 godina.
English: It relieves the symptoms of PAH and improves the course of the disease.
Croatian: To olakšava simptome PAH-a i poboljšava tijek bolesti.
English: Others may reach a maintenance dose somewhere inbetween.
Croatian: Drugi mogu dosegnuti dozu održavanja negdje između te dvije doze.
English: The titration steps usually last about 1 week.
Croatian: Koraci titracije obično traju otprilike tjedan dana.
English: Isolated cases of overdose up to 3,200 micrograms were reported.
Croatian: Zabilježeni su izolirani slučajevi predoziranja do 3200 mikrograma.
English: Treatment should be initiated in the evening.
Croatian: Liječenje treba započeti navečer.
English: • Decompensated cardiac failure if not under close medical supervision.
Croatian: • Dekompenzirano zatajenje srca, ako nije pod strogim medicinskim nadzorom.
English: TITRATION GUIDE - TITRATION PACK Page 1
Croatian: VODIČ ZA TITRACIJU - PAKIRANJE ZA TITRACIJU DOZE Stranica 1
English: Administration of selexipag in the paediatric population is not recommended.
Croatian: Primjena seleksipaga u pedijatrijskoj populaciji se ne preporučuje.
English: The mechanisms are rodent-specific.
Croatian: Mehanizmi su specifični za glodavce.
English: Contents of the pack and other information What Uptravi contains
Croatian: Sadržaj pakiranja i druge informacije Što Uptravi sadrži
English: Uptravi is a medicine taken every morning and evening for the treatment of pulmonary arterial hypertension, also called PAH.
Croatian: Uptravi je lijek koji se uzima svakog jutra i svake večeri za liječenje plućne arterijske hipertenzije, koja se također naziva i PAH.
English: PAH is high blood pressure in the blood vessels that carry blood from the heart to the lungs (the pulmonary arteries).
Croatian: PAH je visoki krvni tlak u krvnim žilama koje vode krv iz srca u pluća (plućne arterije).
English: Morbiditymortality event a
Croatian: Događaj morbiditeta/mor taliteta a
English: In people with PAH, these arteries narrow, so the heart has to work harder to pump blood through them.
Croatian: U ljudi s PAH-om te su arterije sužene pa srce mora raditi jače da bi pumpalo krv kroz njih.
English: They are usually transient or manageable with symptomatic treatment (see section 4.8).
Croatian: One su obično prolazne ili se mogu zbrinuti simptomatskim liječenjem (vidjeti dio 4.8).
English: All events were confirmed by an independent adjudication committee, blinded to treatment allocation.
Croatian: Svi događaji bili su potvrđeni od strane neovisnog arbitražnog povjerenstva koje nije raspolagalo podacima o dodijeljenom liječenju.
English: Write down your doctor or nurse's instructions:
Croatian: Zapišite si upute svog liječnika ili medicinske sestre:
English: Selexipag (N=574)
Croatian: Seleksipag (N=574)
English: Do this only if instructed to do so by your doctor.
Croatian: Učinite tako samo ako Vas je na to uputio Vaš liječnik.
English: If you have been prescribed both 200 and 800 microgram tablets, use pages 30 to 37 (steps 5-8).
Croatian: Ako su Vam propisane i tablete od 200 i tablete od 800 mikrograma, koristite stranice 30 to 37 (5.-8. korak).
English: Take Uptravi once in the morning and once in the evening, about 12 hours apart.
Croatian: Uzimajte Uptravi jednom ujutro i jednom navečer, s razmakom od otprilike 12 sati.
English: Caution is required when administering these medicinal products concomitantly with Uptravi.
Croatian: Potreban je oprez kad se ti lijekovi primjenjuju istodobno s Uptravijem.
English: In the event of overdose, supportive measures must be taken as required.
Croatian: U slučaju predoziranja moraju se primijeniti potporne mjere prema potrebi.
English: When you move to your maintenance dose.............14
Croatian: Kad prelazite na dozu održavanja...........................14
English: The mean age was 48.1 years (range 18-80 years of age), with the majority of subjects being
Croatian: Srednja vrijednost dobi bila je 48,1 godina (raspon 18-80 godina), većina ispitanika bili su bijelci
English: This includes any possible side effects not listed in this leaflet (see section 4).
Croatian: To uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi (pogledajte dio 4.).
English: However, if a patient reaches a dose that cannot be tolerated, the dose should be reduced to the previous dose level.
Croatian: Ipak, ako bolesnik dosegne dozu koju ne može podnositi, dozu treba smanjiti na prethodnu razinu.
English: Table 1 Summary of outcome events
Croatian: Tablica 1 Sažetak ishoda događaja
English: The titration pack also contains a titration guide providing information on the titration process and allowing you to record the number of tablets you take every day.
Croatian: Pakiranje za titraciju doze također sadrži vodič za titraciju s informacijama o tijeku titracije doze i omogućuje Vam upisivanje broja tableta koje uzimate svaki dan.
English: In the first several weeks, you will work with your doctor to find the dose of Uptravi that is right for you.
Croatian: U prvih nekoliko tjedana surađivat ćete sa svojim liječnikom kako biste odredili pravu dozu Uptravija za Vas.
English: 7.5% of patients on selexipag discontinued treatment due to these adverse reactions.
Croatian: 7,5% bolesnika koji primaju seleksipag prekinu liječenje zbog tih nuspojava.
English: Pain-associated events have frequently been treated with analgesics (such as paracetamol).
Croatian: Nuspojave povezane s bolovima često su liječene analgeticima (kao što je paracetamol).
English: This makes it easier for the heart to pump blood through the pulmonary arteries.
Croatian: Na taj način olakšava srcu pumpanje krvi kroz plućne arterije.
English: The MAH shall ensure that in each Member State where Uptravi is marketed, all healthcare professionals who are expected to prescribe and/or dispense Uptravi are provided with a Prescriber Kit containing the following:
Croatian: Nositelj odobrenja osigurat će da da u svakoj državi članici u kojoj se Uptravi stavlja na tržište svi zdravstveni radnici za koje se očekuje da će propisivati i/ili izdavati Uptravi dobiju Komplet za propisivača lijeka koji sadrži sljedeće:
English: The diagram below shows stepping down to a lower dose.
Croatian: Shema ispod prikazuje smanjivanje doze na nižu.
English: For a full description of Uptravi tablets, including colours and marking, please see section 6 of this leaflet.
Croatian: Za cjeloviti opis Uptravi tableta, uključujući boje i oznake, pogledajte dio 6. u ovoj uputi o lijeku.
English: HR (99% CI) p-value
Croatian: HR (99% CI) p-vrijednost
English: * See section Description of selected adverse reactions.
Croatian: * Vidjeti dio: Opis odabranih nuspojava.
English: If confirmed, treatment with Uptravi should be discontinued.
Croatian: Ako se ona potvrdi, treba prekinuti liječenje Uptravijem.
English: Uptravi can cause side effects such as headaches and low blood pressure (see section 4), which may affect your ability to drive; the symptoms of your condition can also make you less fit to drive.
Croatian: Uptravi može uzrokovati nuspojave kao što su glavobolje i nizak krvni tlak (pogledajte dio 4.) koje mogu utjecati na Vašu sposobnost upravljanja vozilima; simptomi Vašeg stanja također mogu umanjiti
English: Hypotension (see section 4.4)
Croatian: hipotenzija (vidjeti dio 4.4)
English: Doctor's office telephone and e-mail:
Croatian: Telefon i e-adresa liječnikovog ureda:
English: If you cannot tolerate the side effects even after your doctor or nurse has tried to treat them, he or she may recommend you step down to a lower dose.
Croatian: Ako ne možete podnijeti nuspojave čak ni nakon što su ih Vaš liječnik ili medicinska sestra pokušali liječiti, on ili ona Vam može preporučiti da si smanjite dozu.
English: This dose will be your maintenance dose.
Croatian: Ta doza bit će Vaša doza održavanja.
English: Pharmacist's telephone:
Croatian: Telefon farmaceuta:
English: There were no mean changes in triiodothyronine or thyroxine in either group.
Croatian: Nije bilo promjena srednjih vrijednosti trijodtironina ili tiroksina ni u jednoj skupini.
English: Your maintenance dose is the dose you should continue to take on a regular basis.
Croatian: Doza održavanja je doza koju trebate nastaviti redovito uzimati.
English: Selexipag and the active metabolite are high-affinity IP receptor agonists with a high selectivity for the IP receptor versus other prostanoid receptors (EP1-EP4, DP, FP, and TP).
Croatian: Seleksipag i aktivni metabolit su agonisti visokog afiniteta za IP receptor s visokom selektivnošću prema IP receptoru u odnosu na druge prostanoidne receptore (EP1-EP4, DP, FP i TP).
English: These are:
Croatian: To su:
English: Selexipag and the active metabolite are not genotoxic on the basis of the overall evidence of conducted genotoxicity studies.
Croatian: Seleksipag i aktivni metabolit nisu genotoksični na temelju ukupnih dokaza iz provedenih ispitivanja genotoksičnosti.
English: You will start at the 200 microgram dose in the morning and in the evening and after discussing with your doctor or nurse step up to the next dose.
Croatian: Počet ćete s dozom od 200 mikrograma ujutro i navečer te nakon razgovora sa svojim liječnikom ili medicinskom sestrom prijeći na sljedeću veću dozu.
English: It lets your body gradually adjust to the medicine.
Croatian: On omogućuje Vašem tijelu da se postupno prilagodi lijeku.
English: Taking other medicines may affect how Uptravi works.
Croatian: Uzimanje drugih lijekova može utjecati na djelovanje Uptravija.
English: Please read the instructions in the package leaflet carefully.
Croatian: Molimo Vas da pažljivo pročitate upute u uputi o lijeku.
English: • Severe arrhythmias.
Croatian: • Teške aritmije.
English: Selectivity against EP2, EP4, and DP1 is important because these receptors mediate immune depressive effects.
Croatian: EP2, EP4 i DP1 je važna jer ovi receptori posreduju imunosupresivne učinke.
English: The highest dose that you can tolerate during titration will become your maintenance dose.
Croatian: Najveća doza koju možete podnijeti tijekom titracije doze postat će Vaša doza održavanja.
English: Individualised maintenance dose
Croatian: Individualizirana doza održavanja
English: There are treatments available that can help relieve them.
Croatian: Postoje dostupni lijekovi koji mogu pomoći olakšati ih.
English: No adjustment to the dose regimen is needed in elderly people (see section 5.2).
Croatian: Nije potrebna prilagodba režima doziranja u starijih osoba (vidjeti dio 5.2).
English: Common (≥ 1/100 to < 1/10)
Croatian: (≥ 1/100 i < 1/10)
English: Safety margins adapted for IP receptor potency for the active metabolite were 2-fold (based on total exposure) in relation to human therapeutic exposure.
Croatian: Granice sigurnosti prilagođene prema potentnosti IP receptora za aktivni metabolit bile su dvostruke (temeljeno na ukupnoj izloženosti) u odnosu na izoženost pri liječenju u ljudi.
English: The volume of distribution of selexipag at steady state is 11.7 L.
Croatian: Volumen distribucije seleksipaga u stanju dinamičke ravnoteže iznosi 11,7 l.
English: This stepping-down process will help you find the dose that is right for you, also called your maintenance dose.
Croatian: Taj proces smanjivanja doze pomoći će Vam da odredite pravu dozu za sebe, koja se također naziva i doza održavanja.
English: Uptravi has vasodilatory properties that may result in lowering of blood pressure.
Croatian: Uptravi ima vazodilatacijska svojstva što može dovesti do snižavanja krvnog tlaka.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Uptravi in one or more subsets of the paediatric population for treatment of pulmonary hypertension, (see section 4.2 for information on paediatric use).
Croatian: Pedijatrijska populacija Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Uptravi u jednoj ili više podskupina pedijatrijske populacije za liječenje plućne hipertenzije (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: • Expectations and management of adverse events during the titration phase;
Croatian: • Očekivanje i zbrinjavanje nuspojava tijekom faze titracije;
English: • Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension.
Croatian: • Prirođeni ili stečeni defekti zalistaka s klinički značajnim poremećajima funkcije miokarda koji nisu povezani s plućnom hipertenzijom.
English: Selexipag and its active metabolite are highly bound to plasma proteins (approximately 99% in total and to the same extent to albumin and alpha1-acid glycoprotein).
Croatian: Seleksipag i njegov aktivni metabolit znatno se vežu za proteine plazme (ukupno približno 99%, i to u istoj mjeri za albumin i alfa-1-kiseli glikoprotein).
English: 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.
Croatian: Klinički status bolesnika i profil nuspojava seleksipaga (poput glavobolje ili hipotenzije) treba imati na umu kad se razmatra bolesnikova sposobnost upravljanja vozilima i rada sa strojevima.
English: Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excluding heparin, ATC code: B01AC27
Croatian: Farmakoterapijska skupina: antitrombotski lijekovi, inhibitori agregacije trombocita izuzev heparina, ATK oznaka: B01AC27
English: 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.
Croatian: Shodno tome, ako se pojave znakovi plućnog edema pri primjeni Uptravija u bolesnika s PAH-om, potrebno je uzeti u obzir mogućnost plućne venookluzivne bolesti.
English: Use them to write down the number of tablets you take in the morning and the evening.
Croatian: Koristite ih za zapisivanje broja tableta koji uzimate ujutro i navečer.
English: Time to PAH-related death or hospitalisation for PAH was assessed as a secondary endpoint.
Croatian: Vrijeme do smrti uzrokovane PAH-om ili hospitalizacije zbog PAH-a procijenjeno je kao sekundarna mjera ishoda.