FrancophonIA/ELRC3.0 huggingface dataset:
English: Blood pressure should be monitored and dose reduction of riociguat be considered.
Croatian: Krvni tlak mora se nadzirati i razmotriti sniženje doze riocigvata.
English: In case treatment has to be interrupted for 3 days or more, treatment should be restarted with 1 mg three times daily for 2 weeks, and continued with the dose titration regimen as described above.
Croatian: U slučaju da liječenje treba prekinuti na 3 dana ili dulje, liječenje je potrebno ponovno započeti dozom od 1 mg tri puta na dan tijekom 2 tjedna pa nastaviti uz titraciju doze kako je opisano gore.
English: Concomitant use with CYP3A4 inducers
Croatian: Istodobna primjena s induktorima CYP3A4
English: The volume of distribution is moderate with volume of distribution at steady state being approximately 30 L.
Croatian: Volumen distribucije je umjeren i u stanju dinamičke ravnoteže iznosi približno 30 l.
English: You will receive Adempas only for special types of pulmonary arterial hypertension (PAH), see section 1.
Croatian: Primit ćete Adempas samo za posebne vrste plućne arterijske hipertenzije (PAH), pogledajte dio 1.
English: In addition, ritonavir showed inhibition of P-gp.
Croatian: Nadalje, ritonavir se pokazao kao inhibitor P-gp-a.
English: However, if you are prone to having low blood pressure (hypotension), you should not switch from taking Adempas with food to taking Adempas without food because it may affect how you react to this medicine.
Croatian: Ipak, ako ste skloni sniženom krvnom tlaku (hipotenziji), ne smijete prijeći s uzimanja lijeka Adempas s hranom na uzimanje lijeka Adempas bez hrane, jer to može utjecati na Vašu reakciju na lijek.
English: The tablet may be crushed and mixed with water or a soft food, such as apple sauce, immediately before you take it.
Croatian: Tableta se može zdrobiti i pomiješati s vodom ili mekom hranom, kao što je kaša od jabuke, neposredno prije uzimanja.
English: With a systemic clearance of about 3-6 L/h, riociguat can be classified as a low-clearance drug.
Croatian: Uz sistemski klirens od približno 3-6 l/sat, riocigvat se može klasificirati kao lijek niskog klirensa.
English: If you have severe liver problems (Child Pugh C), do not take Adempas.
Croatian: Ako imate teške tegobe s jetrom (Child Pugh C), nemojte uzimati Adempas.
English: It may cause side effects such as dizziness.
Croatian: Može prouzročiti nuspojave kao što je omaglica.
English: The tablets should be taken 3 times a day, approximately 6 to 8 hours apart.
Croatian: Tablete treba uzimati 3 puta na dan, u razmaku od približno 6 do 8 sati.
English: Riociguat has vasodilatory properties which may result in lowering of blood pressure.
Croatian: Riocigvat ima vazodilatacijska svojstva koja mogu dovesti do sniženja krvnog tlaka.
English: Inadvertent overdosing with total daily doses of 9 to 25 mg riociguat between 2 to 32 days was reported.
Croatian: Zabilježeno je nehotično predoziranje ukupnim dnevnim dozama od 9 do 25 mg riocigvata između 2 i 32 dana.
English: All patients were WHO Functional Class III and 82% received background therapy with an endothelin receptor antagonist (ERA).
Croatian: Svi bolesnici bili su WHO funkcionalna klasa III i njih 82% primilo je osnovnu terapiju antagonistom endotelinskog receptora (ERA).
English: Riociguat is rapidly absorbed with maximum concentrations (Cmax) appearing 1-1.5 hours after tablet intake.
Croatian: Riocigvat se brzo apsorbira i postiže najveću koncentraciju (Cmax) 1-1,5 sati nakon uzimanja tablete.
English: In cigarette smokers riociguat exposure is reduced by 50-60% (see section 5.2).
Croatian: U pušača je izloženost riocigvatu smanjena za 50-60% (vidjeti dio 5.2).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 March 2014
Croatian: Datum prvog odobrenja: 27. ožujka 2014.
English: Special considerations for patients with kidney or liver problems You should tell your doctor if you have kidney or liver problems.
Croatian: Posebne okolnosti koje treba uzeti u obzir kod bolesnika s bubrežnim i jetrenim tegobama Morate obavijestiti svog liječnika ako imate tegobe s bubrezima ili jetrom.
English: Gastrointestinal and abdominal pains, Constipation, Abdominal distension
Croatian: Gastrointestinalni i abdominalni bolovi, Konstipacija, Abdominalna distenzija
English: There was no evidence of a favourable clinical effect of the combination in the population studied.
Croatian: Nije bilo dokaza da ova kombinacija ima povoljan klinički učinak u ispitivanoj populaciji.
English: 15 to 56
Croatian: 15 do 56
English: 95% CI, [p-value]
Croatian: 95% CI, [p-vrijednost]
English: Intra-cellular cGMP plays an important role in regulating processes that influence vascular tone, proliferation, fibrosis, and inflammation.
Croatian: Unutarstanični cGMP igra važnu ulogu u procesu regulacije koji utječe na tonus krvnih žila, proliferaciju, fibrozu i upalu.
English: you have any symptoms of low blood pressure (hypotension) such as dizziness, lightheadedness, or fainting or if you are taking medicines to lower your blood pressure or medicines that cause an increase in urination or if you have problems with your heart or circulation.
Croatian: - imate simptome niskog krvnog tlaka (hipotenzija) kao što su omaglica, ošamućenost ili nesvjestica ili ako uzimate lijekove za snižavanje krvnog tlaka ili lijekove koji uzrokuju pojačano mokrenje ili ako imate problema sa srcem ili cirkulacijom.
English: If you miss a dose, continue with the next dose as planned.
Croatian: Ako propustite dozu, nastavite s uzimanjem sljedeće doze prema planiranom rasporedu.
English: Concomitant treatment of riociguat and warfarin did not alter prothrombin time induced by the anticoagulant.
Croatian: Istodobno liječenje riocigvatom i varfarinom nije promijenilo protrombinsko vrijeme inducirano antikoagulansom.
English: Elderly patients (65 years or older) exhibited higher plasma concentrations than younger patients, with mean AUC values being approximately 40% higher in elderly, mainly due to reduced (apparent) total and renal clearance.
Croatian: Stariji bolesnici (u dobi od 65 godina ili stariji) imali su veće koncentracije u plazmi nego mlađi bolesnici, s time da su srednje vrijednosti AUC bile približno 40% veća u starijih, uglavnom zbog smanjenog (prividnog) ukupnog i bubrežnog klirensa.
English: Other medicines for high blood pressure in the lung vessels (PAH), such as bosentan and iloprost, can be used with Adempas, but you should still tell your doctor.
Croatian: Drugi lijekovi za povišen krvni tlak u krvnim žilama pluća (PAH), kao što su bosentan i iloprost, mogu se uzimati s lijekom Adempas, ali to morate reći Vašem liječniku.
English: No specific studies with riociguat in humans have been conducted to evaluate effects on fertility.
Croatian: Nisu provedena posebna ispitivanja riocigvata u ljudi da bi se procijenili učinci na plodnost.
English: It works by widening the pulmonary arteries (the blood vessels that connect the heart to the lungs), making it easier for the heart to pump blood through the lungs.
Croatian: Djeluje tako da širi plućne arterije (krvne žile koje povezuju srce s plućima) čime olakšava srcu potiskivanje krvi kroz pluća.
English: The safety profile observed in HIV patients taking a single dose of 0.5 mg riociguat together with different combinations of HIV drugs used in HAART was generally comparable to other patient populations.
Croatian: Sigurnosni profil opažen u bolesnika s HIV infekcijom koji su uzeli jednokratnu dozu od 0,5 mg riocigvata skupa s različitim kombinacijama anti-HIV lijekova korištenih u HAART-u, općenito je bio usporediv s drugim populacijama bolesnika.
English: Adempas can be used for patients with CTEPH who cannot be operated on, or after surgery for patients in whom increased blood pressure in the lungs remains or returns.
Croatian: Adempas se može primjenjivati kod bolesnika s KTEPH-om koje se ne može operirati ili nakon operacije kod bolesnika u kojih je krvni tlak u plućima ostao povišen ili se ponovno povisio.
English: you take blood-thinning medicines (anticoagulants) since this may cause bleeding from the lungs.
Croatian: - uzimate lijekove za razrjeđivanje krvi (antikoagulanse) jer to može uzrokovati krvarenje iz pluća.
English: Tablets should be taken three times daily approximately 6 to 8 hours apart (see section 5.2).
Croatian: Tablete se moraju uzimati tri puta na dan u razmaku od približno 6 do 8 sati (vidjeti dio 5.2).
English: The maximum total daily dose is 7.5 mg i.e., 2.5 mg 3 times daily.
Croatian: Maksimalna ukupna dnevna doza je 7,5 mg, odnosno 2,5 mg 3 puta na dan.
English: • persistent or recurrent CTEPH after surgical treatment, to improve exercise capacity (see section 5.1).
Croatian: • perzistentnim ili recidivirajućim KTEPH-om nakon kirurškog liječenja, za poboljšanje tolerancije napora (vidjeti dio 5.1).
English: - stomach disease or heartburn (antacids such as aluminium hydroxide/magnesium hydroxide).
Croatian: - želučane bolesti ili žgaravice (antacidi kao što su aluminijev hidroksid/magnezijev hidroksid).
English: Therefore, patients are advised to stop smoking (see section 4.2).
Croatian: Stoga se bolesnicima savjetuje da prestanu pušiti (vidjeti dio 4.2).
English: Riociguat (2.5 mg three times per day) did not have a clinically meaningful effect on the plasma levels of combined oral contraceptives containing levonorgestrel and ethinyl estradiol when concomitantly administered to healthy female subjects.
Croatian: Riocigvat (2,5 mg tri puta na dan) nije imao klinički značajan učinak na plazmatsku razinu kombiniranih oralnih kontraceptiva koji sadrže levonorgestrel i etinilestradiol kada se istodobno primijenio zdravim ispitanicama.
English: PP/Aluminium foil blister.
Croatian: Blister od PP/aluminijske folije.
English: You should tell your doctor if you start or stop smoking during treatment with this medicine.
Croatian: Morate reći svom liječniku ako počnete ili prestanete pušiti za vrijeme liječenja ovim lijekom.
English: 35 to 81
Croatian: 35 do 81
English: The use of riociguat in other forms of PAH not studied is not recommended (see section 5.1).
Croatian: Ne preporučuje se primjena riocigvata u drugim oblicima PAH-a koji nisu ispitani (vidjeti dio 5.1).
English: Non-clinical data show undesirable effects on growing bone (see section 5.3).
Croatian: Neklinički podaci pokazuju neželjene učinke na rast kostiju (vidjeti dio 5.3).
English: Riociguat must not be used in patients with a systolic blood pressure below 95 mmHg (see section 4.3).
Croatian: Riocigvat se ne smije primjenjivati u bolesnika sa sistoličkim krvnim tlakom nižim od 95 mmHg (vidjeti dio 4.3).
English: In chronic thromboembolic pulmonary hypertension, pulmonary endarterectomy is the treatment of choice as it is a potentially curative option.
Croatian: U kroničnoj tromboembolijskoj plućnoj hipertenziji, izbor liječenja je plućna endarterektomija jer je to potencijalno kurativna opcija.
English: Riociguat is a type of medicine called a guanylate cyclase (sGC)-stimulator.
Croatian: Riocigvat je vrsta lijeka koji se zove stimulator gvanilatciklaze (sGC).
English: An open-label extension study (CHEST-2) included 237 patients who had completed CHEST-1.
Croatian: Otvoreni produžetak ispitivanja (CHEST-2) uključio je 237 bolesnika koji su završili ispitivanje CHEST-1.
English: In juvenile rats, the changes consisted of thickening of trabecular bone and of hyperostosis and remodeling of metaphyseal and diaphyseal bone, whereas in adolescent rats an overall increase of bone mass was observed.
Croatian: U mladunčadi štakora, promjene su se sastojale od zadebljanja trabekularne kosti i hiperostoze te remodeliranja metafiza i dijafiza kostiju, dok je u adolescentnih štakora opaženo općenito povećanje koštane mase.
English: Your doctor will monitor your health status and should consider a reduced starting dose for Adempas.
Croatian: Liječnik će pratiti Vaše zdravstveno stanje te će razmotriti primjenu smanjene početne doze lijeka Adempas.
English: Do not stop taking this medicine without talking to your doctor first, because this medicine prevents the progression of the disease.
Croatian: Ako prestanete uzimati Adempas Nemojte prestati uzimati ovaj lijek a da prethodno o tome niste razgovarali sa svojim liječnikom, zato što ovaj lijek sprječava napredovanje bolesti.
English: Plasma protein binding in humans is high at approximately 95%, with serum albumin and alpha 1-acidic glycoprotein being the main binding components.
Croatian: Vezanje za proteine plazme u ljudi je visoko i iznosi približno 95%, s time da su serumski albumin i alfa 1-kiseli glikoprotein glavne komponente za koje se veže.
English: - Patients with systolic blood pressure < 95 mm Hg at treatment initiation.
Croatian: - Bolesnici sa sistoličkim krvnim tlakom < 95 mmHg na početku liječenja.
English: Effects of other substances on riociguat
Croatian: Učinci drugih lijekova na riocigvat
English: There is a direct relationship between riociguat plasma concentration and haemodynamic parameters such as systemic and pulmonary vascular resistance, systolic blood pressure and cardiac output.
Croatian: Postoji izravan odnos između koncentracije riocigvata u plazmi i hemodinamičkih parametara kao što su sistemski i plućni vaskularni otpor, sistolički krvni tlak i srčani minutni volumen.
English: Effects observed in repeat-dose toxicity studies were mainly due to the exaggerated pharmacodynamic activity of riociguat (haemodynamic and smooth muscle relaxing effects).
Croatian: Učinci opaženi u ispitivanjima toksičnosti ponovljenih doza bili su uglavnom posljedica pretjeranog farmakodinamičkog djelovanja riocigvata (hemodinamički učinci i relaksirajući učinci na glatke mišiće).
English: An open-label extension study (PATENT-2) included 396 patients who had completed PATENT-1 at the cut-off-date.
Croatian: Otvoreni produžetak ispitivanja (PATENT-2) uključio je 396 bolesnika koji su dovršili ispitivanje PATENT-1 do datuma završetka ispitivanja.
English: Therefore, drug-drug interactions by inhibition of CYP1A1 could result in increased riociguat exposure, especially in smokers (see section 5.2).
Croatian: Stoga bi interakcije između lijekova putem inhibicije CYP1A1 mogle dovesti do povećane izloženosti riocigvatu, osobito u pušača (vidjeti dio 5.2).
English: If you are stopping tadalafil, you must wait at least 48 hours before you take Adempas.
Croatian: - Ako prestajete s tadalafilom, morate pričekati najmanje 48 sati prije nego uzmete Adempas.
English: Your dose may need to be adjusted.
Croatian: Možda će Vam trebati prilagoditi dozu.
English: CYP1A1 catalyses the formation of riociguat's main metabolite in liver and lungs and is known to be inducible by polycyclic aromatic hydrocarbons, which, for example, are present in cigarette smoke.
Croatian: CYP1A1 katalizira stvaranje glavnog metabolita riocigvata u jetri i plućima, a poznato je da ga induciraju policiklički aromatski ugljikovodici, koji su prisutni, na primjer, u duhanskom dimu.
English: Because the heart must work harder than normal, people with pulmonary hypertension feel tired, dizzy and short of breath.
Croatian: Budući da srce mora raditi jače nego uobičajeno, ljudi s povišenim tlakom u plućima osjećaju umor, omaglicu i nedostatak zraka.
English: Most of the adverse reactions are caused by relaxation of smooth muscle cells in vasculature or the gastrointestinal tract.
Croatian: Većina nuspojava uzrokovana je opuštanjem stanica glatkih mišića u krvnim žilama ili gastrointestinalnom traktu.
English: Adempas can be used to treat adults with certain forms of pulmonary hypertension, a condition in which these blood vessels become narrowed, making it harder for the heart to pump blood through them and leading to high blood pressure in the vessels.
Croatian: Adempas se može koristiti za liječenje odraslih bolesnika s određenim oblicima plućne hipertenzije, stanja u kojem su plućne krvne žile postale sužene, što otežava srcu pumpanje krvi kroz njih i vodi do povišenog krvnog tlaka u žilama.
English: • acute bleeding from the lungs (pulmonary haemorrhage) may result in coughing up blood, cases with fatal outcomes were observed (uncommon side effect, may affect up to 1 in 100 people).
Croatian: • akutno krvarenje iz pluća (plućna hemoragija) može rezultirati iskašljavanjem krvi, zabilježeni su slučajevi sa smrtnim ishodom (manje česta nuspojava, može se javiti u do 1 na 100 osoba).
English: Approximately 9-44% of the administered dose was found as unchanged riociguat in faeces.
Croatian: Približno 9-44% primijenjene doze pronađeno je kao nepromijenjeni riocigvat u stolici.
English: iron oxide red (E 172)
Croatian: željezov oksid, crveni (E 172)
English: The safety of Adempas has been evaluated in phase III studies of 681 patients with CTEPH and PAH receiving at least one dose of riociguat (see section 5.1).
Croatian: Sigurnost lijeka Adempas procijenjena je u ispitivanjima faze III u 681 bolesnika s KTEPH-om i PAH-om koji su primili najmanje jednu dozu riocigvata (vidjeti dio 5.1).
English: These findings were in accordance with improvements in additional haemodynamic parameters (see table 5).
Croatian: Ovi su nalazi bili sukladni poboljšanjima dodatnih hemodinamičkih parametara (vidjeti tablicu 5).
English: Your dose may be adjusted.
Croatian: Možda će Vam prilagoditi dozu.
English: -11 to 31
Croatian: -11 do 31
English: For the transition from PDE5 inhibitors to riociguat, median treatment-free time for sildenafil was 1 day and for tadalafil 3 days.
Croatian: Za prelazak s inhibitora PDE-5 na riocigvat, medijan vremena bez liječenja za sildenafil bio je 1 dan, a za tadalafil 3 dana.
English: Patients with ALT > 3 x ULN and bilirubin > 2 x ULN were not studied (see section 4.4).
Croatian: Bolesnici s ALT > 3 x GGN i bilirubinom > 2 x GGN nisu bili ispitani (vidjeti dio 4.4).
English: Breast-feeding should be discontinued during treatment with this medicinal product.
Croatian: Dojenje se mora prekinuti za vrijeme liječenja ovim lijekom.
English: In elderly patients (65 years or older) there is a higher risk of hypotension and therefore particular care should be exercised during individual dose titration (see section 5.2).
Croatian: U starijih bolesnika (u dobi od 65 godina i starijih) postoji povećan rizik od hipotenzije pa je stoga potreban poseban oprez tijekom individualne titracije doze (vidjeti dio 5.2).
English: Should signs of pulmonary oedema occur, the possibility of associated PVOD should be considered and treatment with riociguat should be discontinued.
Croatian: Ako nastanu znakovi plućnog edema, potrebno je razmotriti mogućnost povezanosti s PVOB-om i prekinuti liječenje riocigvatom.
English: There is no clinical experience with riociguat in patients with elevated liver aminotransferases (> 3 x Upper Limit of Normal (ULN)) or with elevated direct bilirubin (> 2 x ULN) prior to initiation of treatment; riociguat is not recommended in these patients.
Croatian: Nema kliničkog iskustva s riocigvatom u bolesnika s povišenim vrijednostima jetrenih aminotransferaza (> 3 x gornje granice normale (GGN)) ili povećanim direktnim bilirubinom (> 2 x GGN) prije početka liječenja; riocigvat se ne preporučuje u ovih bolesnika.
English: With increased doses, over additive effects on systemic blood pressure were observed in some cases.
Croatian: Kod viših su doza u nekim slučajevima bili opaženi i više nego aditivni učinci na sistemski krvni tlak.
English: Improvements in 6MWD persisted at 2 years in PATENT-2.
Croatian: Poboljšanje 6MWD-a nastavilo se tijekom 2 godine u ispitivanju PATENT-2.
English: IIP) (see section 5.1)
Croatian: (PH-IIP) (vidjeti dio 5.1).
English: If you are older than 65 years, you have an increased risk of developing low blood pressure.
Croatian: Ako ste stariji od 65 godina, imate povišen rizik od pojave niskog tlaka.
English: Riociguat restores the NO-sGC-cGMP pathway and leads to increased generation of cGMP.
Croatian: Riocigvat obnavlja put NO-sGC-cGMP i dovodi do povećanog stvaranja cGMP.
English: Improvements in 6MWD persisted at 2 years in CHEST-2.
Croatian: Poboljšanje 6MWD-a nastavilo se tijekom 2 godine u ispitivanju CHEST-2.
English: Riociguat is a stimulator of soluble guanylate cyclase (sGC), an enzyme in the cardiopulmonary system and the receptor for nitric oxide (NO).
Croatian: Riocigvat je stimulator topljive gvanilat-ciklaze (sGC), enzima u kardiopulmonalnom sustavu i receptora za dušikov oksid (NO).
English: Moderate passage across the placental barrier was observed.
Croatian: Opažen je umjereni prolazak riocigvata kroz placentalnu barijeru.
English: Table 1: Adverse reactions reported with Adempas in the phase III studies MedDRA
Croatian: Tablica 1: Nuspojave zabilježene uz Adempas u ispitivanjima faze III
English: Adempas is only prescribed for certain forms of PAH, i.e. idiopathic PAH (the cause of PAH is unknown), heritable PAH and PAH caused by connective tissue disease.
Croatian: Adempas se propisuje samo za određene oblike PAH-a, odnosno za idiopatski PAH (uzrok PAH-a je nepoznat), nasljedni PAH i PAH uzrokovan bolešću vezivnog tkiva.
English: In the long term extension part of this study (non controlled) the concomitant use of sildenafil and riociguat resulted in a high rate of discontinuation, predominately due to hypotension.
Croatian: U dugoročnom nastavku ovog ispitivanja (nekontroliranom) istodobna primjena sildenafila i riocigvata dovela je do visoke stope prekida liječenja, pretežno zbog hipotenzije.
English: 29 to 79
Croatian: 29 do 79
English: Adempas has moderate influence on the ability to drive and use machines.
Croatian: Adempas umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza oznake „EXP“.
English: Cobicistat, ritonavir, atazanavir and darunavir are additionally classified as CYP3A inhibitors.
Croatian: Kobicistat, ritonavir, atazanavir i darunavir dodatno se klasificiraju kao CYP3A inhibitori.
English: If you are breast-feeding or planning to breast-feed, ask your doctor or pharmacist for advice before taking this medicine because it might harm your baby.
Croatian: Ako dojite ili planirate dojiti, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek, zato što može naškoditi djetetu.
English: Your doctor will decide with you if you either should stop breast-feeding or stop treatment with Adempas.
Croatian: Vaš će liječnik odlučiti zajedno s Vama hoćete li prestati dojiti ili prekinuti liječenje lijekom Adempas.
English: Lack of pharmacokinetic interactions between riociguat and the CYP2C9 substrate warfarin was demonstrated in vivo.
Croatian: Nedostatak farmakokinetičkih interakcija između riocigvata i supstrata CYP2C9 varfarina dokazan je in vivo.
English: Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD).
Croatian: Plućni vazodilatatori mogu značajno pogoršati kardiovaskularno stanje bolesnika s plućnom venookluzivnom bolešću (PVOB).
English: Strong CYP1A1 inhibitors should be used with caution (see section 4.4).
Croatian: Jaki inhibitori CYP1A1 moraju se primjenjivati s oprezom (vidjeti dio 4.4).
English: It sensitises sGC to endogenous NO by stabilising the NO-sGC binding.
Croatian: Senzibilizira sGC na endogeni NO tako što stabilizira vezu NO-sGC.
English: Approximately 4-19% of the administered dose was excreted as unchanged riociguat via the kidneys.
Croatian: Približno 4-19% primijenjene doze bilo je izlučeno kao nepromijenjeni riocigvat putem bubrega.
English: Dizziness has been reported and may affect the ability to drive and use machines (see section 4.8).
Croatian: Zabilježena je omaglica koja može utjecati na sposobnost upravljanja vozilima i rada sa strojevima (vidjeti dio 4.8).
English: Hospitalisations due to PH Decrease in 6MWD due to PH Persistent worsening of Functional Class due to PH
Croatian: Bolesnici s bilo kakvim kliničkim pogoršanjem smrt hospitalizacije zbog PH smanjenje 6MWD zbog PH uporno pogoršavanje funkcionalnog razreda zbog PH početak novog liječenja PH