FrancophonIA/ELRC3.0 huggingface dataset:
English: In the event of clinical deterioration (e.g., decrease in 6-minute walk test distance by at least 10% compared with pre-treatment measurement) despite STAYVEER treatment for at least 8 weeks (target dose for at least 4 weeks), alternative therapies should be considered.
Croatian: U slučaju kliničkog pogoršanja (npr. smanjenje prijeđene udaljenosti u 6-minutnom testu hoda za najmanje 10% u odnosu na mjerenje prije liječenja) unatoč liječenju STAYVEEROM u trajanju od najmanje 8 tjedana (ciljna doza uzimana najmanje 4 tjedna), potrebno je razmotriti alternativne terapije.
English: Anaphylaxis and/or angioedema1
Croatian: Anafilaksija i/ili angioedem1
English: 40.6% (26/64) remained on bosentan monotherapy during the 24 weeks of study treatment without experiencing PAH worsening.
Croatian: 40,6% (26/64) i dalje su liječeni bosentanom u monoterapiji tijekom 24 tjedna ispitivanog liječenja bez pogoršanja PAH-a.
English: There was no relevant difference in adverse event frequencies between patients above and below the age of 2 years; however, this is based on only 21 children less than 2 years, including 6 patients between 3 months to 1 year of age.
Croatian: Nije bilo značajne razlike u učestalosti štetnih događaja između bolesnika mlađih i starijih od 2 godine, no to se temelji na samo 21 djetetu mlađem od 2 godine, uključujući 6 bolesnika između 3 mjeseca i 1 godine starosti.
English: Half of the patients in each group were already being treated with intravenous epoprostenol and the dose of epoprostenol remained constant for the duration of the study.
Croatian: Pola bolesnika u svakoj skupini je već dobivalo intravenski epoprostenol te je doza epoprostenola ostala nepromijenjena tijekom studije.
English: Animal studies showed testicular effects (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su učinke na testise (vidjeti dio 5.3).
English: Overall, 78% of patients remained in WHO functional class II.
Croatian: Sveukupno, 78% bolesnika ostalo je u funkcionalnoj klasi II prema smjernicama Svjetske zdravstvene organizacije (WHO).
English: Teratogenic effects, including malformations of the head and face and of the major vessels, were dose dependent.
Croatian: Teratogeni učinci, uključujući malformacije glave i lica te većih krvnih žila, bili su ovisni o dozi.
English: Moreover, if you are suffering from pulmonary hypertension disease, the occurrence of a pregnancy can severely deteriorate the symptoms of your disease.
Croatian: Osim toga, ako bolujete od plućne hipertenzije, trudnoća može jako pogoršati simptome
English: The pharmacokinetics of bosentan have mainly been documented in healthy subjects.
Croatian: Farmakokinetika bosentana uglavnom je ispitana kod zdravih osoba.
English: • Anaphylaxis (general allergic reaction), angioedema (swelling, most commonly around the eyes,
Croatian: • Anafilaksija (generalizirana alergijska reakcija), angioedem (oticanje, najčešće oko očiju, usana,
English: The most common adverse reaction was headache of mild to moderate intensity.
Croatian: Najčešća nuspojava bila je glavobolja blagog do umjerenog intenziteta.
English: Pharmacokinetic data are not available for STAYVEER in young children with this disease.
Croatian: Nema farmakokinetičkih podataka za STAYVEER kod male djece s ovom bolešću.
English: In the clinical programme, dose-dependent elevations in liver aminotransferases generally occurred within the first 26 weeks of treatment, usually developed gradually, and were mainly asymptomatic.
Croatian: Tijekom kliničkog programa, povišenje jetrenih aminotransferaza ovisno o dozi javilo se uglavnom tijekom prvih 26 tjedana, većinom se postupno razvilo te je bilo pretežno asimptomatsko.
English: Your liver and blood values will be monitored during treatment with STAYVEER (see section 2).
Croatian: Funkcija jetre i krvna slika će se pratiti za vrijeme liječenja STAYVEEROM (pogledajte dio 2).
English: Patients should be advised not to swallow the desiccant found in the white high-density polyethylene bottles.
Croatian: Bolesnike treba upozoriti na to da ne smiju progutati sredstvo za sušenje koje se nalazi u bijelim bocama od polietilena visoke gustoće.
English: The most frequent adverse events were upper respiratory tract infections (25%), pulmonary (arterial) hypertension (20%), nasopharyngitis (17%), pyrexia (15%), vomiting (13%), bronchitis (10%), abdominal pain (10%), and diarrhoea (10%).
Croatian: Najčešći štetni događaji bili su infekcije gornjeg dijela dišnog sustava (25%), plućna (arterijska) hipertenzija (20%), nazofaringitis (17%), pireksija (15%), povraćanje (13%), bronhitis (10%), abdominalna bol (10%) i proljev (10%).
English: In the FUTURE 1 study, the median exposure to study treatment was 13.1 weeks (range: 8.4 to 21.1).
Croatian: FUTURE 1 studiji medijan izloženosti ispitivanom liječenju bio je 13,1 tjedana (raspon 8,4 do 21,1).
English: As a result, a significantly reduced effect of bosentan is expected when it is co-administered with rifampicin.
Croatian: Kao rezultat, očekuje se značajno smanjenje učinka bosentana kod istodobne primjene s rifampicinoma.
English: • primary (with no identified cause or familial);
Croatian: STAYVEER može biti: • primarna (bez poznatog uzroka ili obiteljska);
English: Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO functional class III.
Croatian: Liječenje plućne arterijske hipertenzije (PAH) kako bi se poboljšao kapacitet fizičkog opterećenja i simptomi kod bolesnika s WHO funkcionalnim stupnjem III.
English: Studies performed in children with pulmonary arterial hypertension
Croatian: Studije provedene u djece s plućnom arterijskom hipertenzijom
English: In patients with severe renal impairment (creatinine clearance 15-30 mL/min), plasma concentrations of bosentan decreased by approximately 10%.
Croatian: U bolesnika s teškim smanjenjem bubrežne funkcije (klirens kreatinina je 15-30 ml/min), koncentracije bosentana u plazmi smanjile su se za oko 10%.
English: • facilitate patients' awareness of the need for regular blood tests for liver function.
Croatian: • podići svijest bolesnika o potrebi redovitog provođenja krvnih pretraga za jetrenu funkciju.
English: Long-term data were generated from all 173 patients who were treated with bosentan in the controlled phase and/or were switched from placebo to bosentan in the open-label extension phase of the EARLY study.
Croatian: Dugoročni podaci su dobiveni od svih 173 pacijenata koji su liječeni s bosentanom u kontrolnoj fazi i/ili koji su s placeba prešli na bosentan u produžnoj otvorenoj fazi liječenja u ispitivanju EARLY.
English: If it is possible that you could become pregnant, use a reliable form of birth control (contraception) while you are taking STAYVEER.
Croatian: Ako postoji mogućnost da ostanete trudni, koristite pouzdan oblik kontrole začeća (kontracepciju) za vrijeme uzimanja STAYVEERA.
English: Suddenly stopping your treatment with STAYVEER may lead to your symptoms getting worse.
Croatian: Nagli prestanak liječenja s lijekom STAYVEER može dovesti do pogoršanja Vaših simptoma.
English: The differences between the two groups, 125 mg twice daily and 250 mg twice daily, were not statistically significant but there was a trend towards improved exercise capacity in the group treated with 250 mg twice daily.
Croatian: Razlike između dvije skupine, koje su dobivale 125 mg dvaput dnevno i 250 mg dvaput dnevno, nisu bile statistički značajne, no postojao je trend poboljšanja fizičkih sposobnosti u skupini koja je dobivala 250 mg dvaput dnevno.
English: Although not demonstrated through in vivo studies, similar increases in bosentan plasma concentrations are expected with the other potent CYP3A4 inhibitors (such as itraconazole or ritonavir).
Croatian: Premda nije dokazano u studijama in vivo, slična povećanja koncentracije bosentana u plazmi očekuju se i za druge jake inhibitore CYP3A4 (poput itrakonazola ili ritonavira).
English: The neurohormone endothelin-1 (ET-1) is one of the most potent vasoconstrictors known and can also promote fibrosis, cell proliferation, cardiac hypertrophy and remodelling, and is pro-inflammatory.
Croatian: Neurohormon endotelin-1 (ET-1) jedan je od najjačih poznatih vazokonstriktora, a također može potaknuti fibrozu, staničnu proliferaciju, hipertrofiju i remodeliranje srca te djeluje proinflamatorno.
English: The influence of CYP2C9 inhibitors on bosentan concentration has not been studied.
Croatian: Utjecaj inhibitora CYP2C9 na koncentraciju bosentana nije ispitan.
English: The overall change in WHO functional class during both studies was significantly better among bosentan-treated patients as compared with placebo-treated patients.
Croatian: Ukupna promjena WHO funkcionalnog stupnja tijekom obje studije bila je znatno bolja među bolesnicima koji su dobivali bosentan u odnosu na one koji su dobivali placebo.
English: Bosentan competes with the binding of ET-1 and other ET peptides to both ETA and ETB receptors, with a slightly higher affinity for ETA receptors (Ki = 4.1-43 nanomolar) than for ETB receptors (Ki = 38-730 nanomolar).
Croatian: Bosentan se nadmeće s ET-1 i drugim ET-peptidima za vezanje za receptore ETA i ETB, s nešto većim afinitetom za receptore ETA (Ki = 4,1-43 nanomola) nego za receptore ETB (Ki = 38-730 nanomola).
English: Inhibition of these isoenzymes may increase the plasma concentration of bosentan (see ketoconazole).
Croatian: Inhibicija tih izoenzima može povećati koncentracije bosentana u plazmi (vidjeti ketokonazol).
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake kategorije učestalosti nuspojave su prikazane prema sve manjoj ozbiljnosti.
English: • Syncope (fainting)
Croatian: • Sinkopa (nesvjestica)
English: For all these tests please refer also to the Patient Alert Card (inside your pack of STAYVEER tablets).
Croatian: Molimo da za sve ove pretrage pogledate i Karticu s upozorenjima za bolesnika (unutar Vašeg pakiranja STAYVEER tableta).
English: No formal conclusion can be drawn regarding the effects of bosentan on antiretroviral drug efficacy (see also section 4.4).
Croatian: Ne mogu se donijeti službeni zaključci s obzirom na utjecaj bosentana na antiretrovirusnu terapiju (vidjeti također dio 4.4).
English: • caused by congenital (inborn) heart defects with shunts (abnormal passageways) causing abnormal flow of blood through the heart and lungs.
Croatian: • uzrokovana kongenitalnim (urođenim) srčanim greškama sa šantovima (abnormalnim prolazima) koji uzrokuju nenormalno protjecanje krvi kroz srce i pluća.
English: These haemodynamic improvements from baseline were similar with or without co-administration of epoprostenol.
Croatian: Ta hemodinamička poboljšanja u odnosu na početnu vrijednost bila su slična sa ili bez istodobne primjene epoprostenola.
English: 9 patients were newly initiated on PAH-specific medication during the study.
Croatian: 9 bolesnika je prvi puta započelo s liječenjem specifičnim za PAH tijekom studije.
English: In the post-marketing period there was one reported overdose of 10,000 mg of bosentan taken by an adolescent male patient.
Croatian: Tijekom postmarketinškog razdoblja zabilježen je jedan slučaj predoziranja s 10 000 mg bosentana u muškog adolescenta.
English: The mean duration of exposure to bosentan treatment was 3.6 ± 1.8 years (up to 6.1 years), with 73% of patients treated for at least 3 years and 62% for at least 4 years.
Croatian: Srednje trajanje izloženosti liječenju bosentanom bila je 3,6 ± 1,8 godina (do 6,1 godina), s time da je 73% bolesnika liječeno barem 3 godine, a 62% barem 4 godine.
English: In vitro data also suggest an induction of CYP2C19.
Croatian: Podaci in vitro također ukazuju na indukciju CYP2C19.
English: At the end of this study, there was no difference in overall hospitalisations for heart failure nor in mortality between bosentan- and placebo-treated patients.
Croatian: Na kraju studije nije bilo razlike između broja ukupnih hospitalizacija zbog zatajenja srca niti u smrtnosti između bolesnika koji su dobivali bosentan, odnosno placebo.
English: Liver enzyme changes typically occur within the first 26 weeks of treatment but may also occur late in treatment (see section 4.8).
Croatian: Promjene u vrijednostima jetrenih enzima javljaju se uglavnom tijekom prvih 26 tjedana liječenja, ali se također mogu javiti u kasnijoj fazi liječenja (vidjeti dio 4.8).
English: The relative contributions of previous placebo treatment in the double-blind phase and of other medications started during the open-label extension period are unknown.
Croatian: Nisu poznati relativni doprinosi prethodnog liječenja placebom u dvostruko slijepoj fazi ispitivanja i drugih lijekova koje se počelo uzimati tijekom otvorenog perioda produžetka liječenja.
English: The duration of double-blind therapy was 16 weeks in study AC-052-401, and 24 weeks in study AC-052-331.
Croatian: Trajanje dvostruko slijepe terapije bilo je 16 tjedana za studiju AC-052-401 i 24 tjedna za studiju AC-052-331.
English: STAYVEER therefore causes blood vessels to expand and belongs to the class of medicines called “endothelin receptor antagonists”.
Croatian: Zbog toga STAYVEER širi krvne žile i ubraja se u skupinu lijekova pod nazivom „antagonisti endotelinskih receptora“.
English: Haupt Pharma Wülfing GmbH Bethelner Landstraße 18 31028 Gronau/Leine Germany
Croatian: Haupt Pharma Wülfing GmbH Bethelner Landstraße 18
English: STAYVEER is contraindicated in pregnancy (see section 4.3).
Croatian: STAYVEER je kontraindiciran u trudnoći (vidjeti dio 4.3).
English: The median treatment duration was 71.8 weeks (range 0.4-258 weeks).
Croatian: Medijan trajanja liječenja bio je 71,8 tjedana (raspon 0,4 - 258 tjedana).
English: At steady state, the systemic exposures in paediatric patients weighing 10-20 kg, 20-40 kg and > 40 kg were 43%, 67% and 75%, respectively, of the adult systemic exposure.
Croatian: U stanju dinamičke ravnoteže, sistemske izloženosti pedijatrijskih bolesnika koji su težili 10-20 kg, 20-40 kg i > 40 kg iznosile su 43%, 67%, odnosno 75% sistemske izloženosti kod odraslih.
English: Nasal congestion1
Croatian: Nazalna kongestija1
English: Please read this card carefully before starting your treatment with STAYVEER.
Croatian: Molimo Vas da pažljivo pročitate sljedeći tekst prije nego što počnete uzimati lijek STAYVEER.
English: We suggest you write the date of your most recent test and also of your next test (ask your doctor for the date) on the Patient Alert Card, to help you remember when your next test is due.
Croatian: Predlažemo da zabilježite datum zadnje pretrage te datum iduće pretrage (upitajte liječnika za datum) u Karticu za bolesnika kako biste si pomogli upamtiti datum iduće pretrage.
English: • Women of childbearing potential who are not using reliable methods of contraception (see sections 4.4, 4.5 and 4.6)
Croatian: • Žene reproduktivne dobi koje ne primjenjuju pouzdane metode kontracepcije (vidjeti dijelove 4.4, 4.5 i 4.6)
English: Steady-state conditions are reached within 3-5 days.
Croatian: Stanje dinamičke ravnoteže uspostavlja se unutar 3-5 dana.
English: After 16 weeks, the mean oxygen saturation was increased in the bosentan group by 1.0% (95% CI -0.7%-2.8%) as compared to the placebo group (n = 17), showing that bosentan did not worsen hypoxaemia.
Croatian: Nakon 16 tjedana srednje zasićenje kisikom bilo je povećano za 1,0% u skupini koja je dobivala bosentan (95% CI0,7%-2,8%) u odnosu na skupinu koja je dobivala placebo (n=17), što pokazuje da bosentan nije pogoršao hipoksemiju.
English: In neonates with persistent pulmonary hypertension of the newborn (PPHN), the benefit of bosentan has not been shown in the standard-of-care treatment.
Croatian: U novorođenčadi s perzistentnom plućnom hipertenzijom novorođenčeta (PPHN) nije se pokazala korist bosentana u standardnom liječenju.
English: Inside your pack of STAYVEER tablets you will find a Patient Alert Card which you should read carefully.
Croatian: U Vašem pakiranju tableta STAYVEER naći ćete Karticu s upozorenjima za bolesnika koju trebate pažljivo pročitati.
English: In the event of late clinical deterioration despite treatment with STAYVEER (i.e., after several months of treatment), the treatment should be re-assessed.
Croatian: U slučaju naknadnog pogoršanja kliničke slike unatoč uzimanju STAYVEERA (tj. nakon nekoliko mjeseci liječenja), treba ponovo razmotriti način liječenja.
English: Therefore, women of childbearing potential must not use hormonal contraceptives (including oral, injectable, transdermal or implantable forms) as the sole method of contraception but must use an additional or an alternative reliable method of contraception.
Croatian: Stoga žene reproduktivne dobi ne smiju uzimati hormonske kontraceptive (uključujući oralne, injekcijske, transdermalne ili implantacijske oblike) kao jedinu metodu kontracepcije, već također moraju uzimati dodatnu ili alternativnu pouzdanu metodu kontracepcije.
English: Other antiretroviral agents: No specific recommendation can be made with regard to other available antiretroviral agents due to the lack of data.
Croatian: Drugi antiretrovirusni lijekovi: zbog nedostatka podataka nema specifične preporuke glede drugih dostupnih antiretrovirusnih lijekova.
English: STAYVEER tablets contain bosentan, which blocks a naturally occurring hormone called endothelin-1 (ET-1), which causes blood vessels to narrow.
Croatian: Tablete STAYVEER sadrže bosentan, blokator prirodnog hormona endotelina-1 (ET-1) koji sužava krvne žile.
English: Bosentan is a dual endothelin receptor antagonist (ERA) with affinity for both endothelin A and B (ETA and ETB) receptors.
Croatian: Bosentan je dvojni antagonist endotelinskih receptora s afinitetom za endotelin A- i B-receptore (ETA i
English: Gender and concomitant use of intravenous epoprostenol had no significant effect on the pharmacokinetics of bosentan.
Croatian: Spol i istodobna intravenska primjena epoprostenola nisu imali značajniji utjecaj na farmakokinetiku bosentana.
English: Anaemia or haemoglobin decreases requiring red blood cell transfusion1
Croatian: Anemija ili smanjenje koncentracije hemoglobina koje zahtijeva transfuziju crvenih krvnih stanica1
English: In addition, liver aminotransferase levels must be measured 2 weeks after any dose increase.
Croatian: Vrijednosti jetrenih aminotransferaza treba također mjeriti 2 tjedna nakon svakog povećanja doze.
English: Treatment with bosentan was associated with a significant reduction in the rate of clinical worsening compared with placebo at 28 weeks (10.7% vs 37.1%, respectively; p = 0.0015).
Croatian: Liječenje bosentanom dovelo je do značajnog smanjenja brzine pogoršanja kliničke slike u odnosu na placebo nakon 28 tjedana (10,7% u odnosu na 37,1% ; p = 0,0015).
English: In vitro, bosentan inhibits the bile salt export pump in hepatocyte cultures.
Croatian: In vitro, bosentan inhibira eksportnu crpku za žučne soli u kulturama hepatocita.
English: Bosentan was added to patients' current therapy, which could include a combination of anticoagulants, vasodilators (e.g., calcium channel blockers), diuretics, oxygen and digoxin, but not epoprostenol.
Croatian: Bosentan je dodan terapiji koju je bolesnik u tom trenutku dobivao, a moglo se raditi o kombinaciji antikoagulansa, vazodilatatora (npr. blokatora kalcijevih kanala), diuretika, kisika, digoksina, ali ne i epoprostenola.
English: However, decreases in exposure were as much as 56% and 66%, respectively, in individual subjects.
Croatian: U nekih osoba smanjenje je iznosilo do 56%, odnosno 66%.
English: No dose adjustment of STAYVEER is considered necessary.
Croatian: Prilagođavanje doze STAYVEERA nije potrebno.
English: In placebo-controlled studies, bosentan-related decreases in haemoglobin concentration were not progressive, and stabilised after the first 4-12 weeks of treatment.
Croatian: U placebom kontroliranim studijama smanjenje koncentracije hemoglobina uzrokovano bosentanom nije bilo progresivno te se ustalilo nakon prvih 4-12 tjedana liječenja.
English: Kaplan-Meier estimates of survival were 90% and 85% at 3 and 4 years after the start of treatment, respectively.
Croatian: Kaplan-Meier procjene preživljenja bile su 90% odnosno 85% u 3. odnosno 4. godini nakon početka liječenja.
English: An increase in minute ventilation and a decrease in oxygen saturation were observed, and the most frequent adverse event was dyspnoea, which resolved with discontinuation of bosentan.
Croatian: Primijećeno je povećanje minutne ventilacije i smanjenje zasićenja kisikom, a najčešća nuspojava bila je dispneja koja je prestala prekidom uzimanja bosentana.
English: In male children, a long-term impact on fertility after treatment with bosentan cannot be excluded.
Croatian: U muške djece se ne može isključiti dugoročan utjecaj na plodnost nakon liječenja bosentanom.
English: Patients could receive additional PAH treatment as required in the open-label extension.
Croatian: Bolesnici su mogli dobiti dodatno liječenje PAH-a prema potrebi u otvorenom produžetku liječenja.
English: In PAH and heart failure, in the absence of endothelin receptor antagonism, elevated ET-1 concentrations are strongly correlated with the severity and prognosis of these diseases.
Croatian: Kod PAH-a i zatajenja srca, u odsustnosti antagonista endotelinskih receptora, povišene koncentracije ET-1 strogo koreliraju s težinom i prognozom tih bolesti.
English: ET-1 concentrations in tissues and plasma are increased in several cardiovascular disorders and connective tissue diseases, including PAH, scleroderma, acute and chronic heart failure, myocardial ischaemia, systemic hypertension and atherosclerosis, suggesting a pathogenic role of ET-1 in these diseases.
Croatian: Koncentracije ET-1 u tkivima i plazmi su povećane kod nekih kardiovaskularnih poremećaja i bolesti vezivnog tkiva, uključujući PAH, sklerodermiju, akutno i kronično zatajenje srca, ishemiju miokarda, sistemsku hipertenziju i aterosklerozu, što ukazuje na patogenu ulogu ET-1 kod tih bolesti.
English: Bosentan does not penetrate into erythrocytes.
Croatian: Bosentan ne prodire u eritrocite.
English: However, no effects on general development, growth, sensory, cognitive function and reproductive performance were detected at 7 (males) and 19 (females) times the human therapeutic exposure at Day 21 post partum.
Croatian: Ipak, nisu zabilježeni učinci na opći razvoj, rast, senzornu i kognitivnu funkciju te sposobnost razmnožavanja pri izloženosti 7 puta (mužjaci) i 19 puta (ženke) većoj od terapijske izloženosti u ljudi na 21. postpartalni dan.
English: • Pulmonary arterial hypertension (PAH): PAH is a disease of severe narrowing of the blood vessels in the lungs resulting in high blood pressure in the blood vessels (the pulmonary arteries) that carry blood from the heart to the lungs.
Croatian: • plućne arterijske hipertenzije (PAH): plućna arterijska hipertenzija je bolest u kojoj jako suženje krvnih žila u plućima izaziva visok krvni tlak u krvnim žilama (plućnim arterijama) koje prenose krv od srca prema plućima.
English: Note: bosentan is not removed through dialysis.
Croatian: Napomena: bosentan se ne uklanja dijalizom.
English: Pulmonary arterial hypertension associated with HIV infection
Croatian: Plućna arterijska hipertenzija povezana s HIV infekcijom
English: • STAYVEER treatment must not be initiated in women of childbearing potential unless they practise reliable contraception and the result of the pre-treatment pregnancy test is negative
Croatian: • Liječenje STAYVEEROM ne smije se započeti u žena reproduktivne dobi ako ne provode pouzdane metode kontracepcije i ako test na trudnoću prije liječenja nije negativan
English: At enrolment, six patients were between 3 months and 1 year old, 15 children were between 1 and less than 2 years old, and 79 were between 2 and 12 years old.
Croatian: Pri uključenju, 6 bolesnika bilo je u dobi od 3 mjeseca do 1 godine, 15 djece bilo je u dobi od 1 do manje od 2 godine i 79 ih je bilo u dobi od 2 do 12 godina.