FrancophonIA/ELRC3.0 huggingface dataset:
English: Bosentan is highly bound (> 98%) to plasma proteins, mainly albumin.
Croatian: Bosentan je u velikom postotku vezan (> 98%) za proteine plazme, uglavnom albumin.
English: Important Safety Alerts for Patients taking STAYVEER (bosentan)
Croatian: Važna sigurnosna upozorenja za bolesnike koji uzimaju STAYVEER (bosentan)
English: Contents of the pack and other information What STAYVEER contains
Croatian: Sadržaj pakiranja i druge informacije Što STAYVEER sadrži
English: • if you are allergic to bosentan or any of the other ingredients of this medicine (listed in section 6)
Croatian: • ako ste alergični na bosentan ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6)
English: Invasive haemodynamic parameters were assessed in the first study only.
Croatian: Invazivni hemodinamički parametri određeni su samo u prvoj studiji.
English: EXP {MM/YYYY} Use within 30 days after the first opening
Croatian: EXP {MM/GGGG} Upotrijebiti unutar 30 dana od prvog otvaranja
English: STAYVEER is used to treat:
Croatian: STAYVEER se koristi za liječenje:
English: Placebo (n=88) Bosentan (n=80) Placebo (n=91) Bosentan (n=86)
Croatian: Placebo (n=88) Bosentan (n=80) Placebo (n=91)
English: The consequences of these findings regarding hepatotoxicity are unknown.
Croatian: Posljedice tih nalaza vezano za hepatoksičnost nisu poznate.
English: • if you are pregnant, or could get pregnant because you are not using reliable contraceptive methods.
Croatian: • ako ste trudni ili biste mogli zatrudnjeti zbog toga što ne koristite pouzdane metode kontracepcije.
English: The maximum plasma concentrations are attained within 3-5 hours.
Croatian: Maksimalne koncentracije u plazmi dostignute su unutar 3-5 sati.
English: If you have the impression that the effect of STAYVEER is too strong or too weak, talk to your doctor in order to find out whether your dose needs to be changed.
Croatian: Ako imate osjećaj da je učinak STAYVEERA prejak ili preslab, razgovarajte sa svojim liječnikom kako biste utvrdili postoji li potreba za promjenom doze.
English: In healthy subjects, the absolute bioavailability of bosentan is approximately 50% and is not affected by food.
Croatian: Kod zdravih osoba, apsolutna bioraspoloživost bosentana iznosi oko 50% i hrana ne utječe na nju.
English: A volume of distribution (Vss) of about 18 litres was determined after an intravenous dose of 250 mg.
Croatian: Volumen raspodjele (Vss) od oko 18 litara bio je utvrđen nakon intravenske doze od 250 mg.
English: Efficacy has been shown in:
Croatian: Djelotvornost je dokazana kod:
English: Only one death occurred in each treatment group during the 6-month double-blind study period, therefore no conclusion can be drawn on survival.
Croatian: Došlo je do jednog smrtnog slučaja u svakoj skupini tijekom šestomjesečne dvostruko slijepe studije pa se ne može donijeti zaključak o utjecaju na preživljenje.
English: The film-coated tablets are to be swallowed with water.
Croatian: Filmom obložene tablete treba progutati s vodom.
English: • other medications for the treatment of pulmonary hypertension: sildenafil and tadalafil;
Croatian: • drugi lijekovi za liječenje plućne hipertenzije: sildenafil i tadalafil;
English: The plasma concentrations of bosentan were also decreased by 29%.
Croatian: Koncentracije bosentana u plazmi bile su također smanjene za 29%.
English: Bosentan was negative in tests for genotoxicity.
Croatian: Bosentan je negativan u testovima genotoksičnosti.
English: Eisenmenger's physiology
Croatian: Eisenmengerovom fiziologijom
English: Your doctor and/or gynaecologist will establish the contraception which is appropriate for you.
Croatian: Vaš liječnik i/ili ginekolog odredit će kontracepciju prikladnu za Vas.
English: Tadalafil did not affect the exposure (AUC and Cmax) of bosentan or its metabolites.
Croatian: Tadalafil nije utjecao na izloženost (AUC i Cmax) bosentana ili njegovih metabolita.
English: No clinically relevant differences in adverse reactions were observed between the overall dataset and the approved indications.
Croatian: Nisu zapažene klinički značajne razlike u nuspojavama između cjelokupnog zbira podataka i odobrenih indikacija.
English: This pressure reduces the amount of oxygen that can get into the blood in the lungs, making physical activity more difficult.
Croatian: Taj tlak smanjuje količinu kisika koja u plućima ulazi u krv i na taj način otežava fizičku aktivnost.
English: If there is any doubt about what contraceptive advice should be given to the individual patient, consultation with a gynaecologist is recommended.
Croatian: Postoji li nedoumica o vrsti kontracepcijskog sredstva primjerenog pojedinoj bolesnici, preporučuje se savjetovanje s ginekologom.
English: However, to avoid the possible occurrence of harmful clinical deterioration due to potential rebound effect, gradual dose reduction (halving the dose for 3 to 7 days) should be considered.
Croatian: Međutim, kako bi se izbjegla moguća pojava štetnog kliničkog pogoršanja zbog potencijalnog rebound učinka, preporučuje se postupno smanjivanje doze (primijeniti pola doze tijekom 3 do 7 dana).
English: Increasing the dose or the dosing frequency will likely not result in additional clinical benefit.
Croatian: Povećanje doze ili učestalosti doziranja vjerojatno neće rezultirati dodatnom kliničkom koristi.
English: • warfarin (an anticoagulant agent);
Croatian: • varfarin (antikoagulans);
English: If you take more STAYVEER than you should
Croatian: Ako uzmete više STAYVEERA nego što ste trebali
English: No dose adjustment is required in patients over the age of 65 years.
Croatian: Prilagođavanje doze nije potrebno kod bolesnika starijih od 65 godina.
English: Massive overdose may result in pronounced hypotension requiring active cardiovascular support.
Croatian: Masivno predoziranje može prouzročiti izrazitu hipotenziju koja zahtijeva aktivnu kardiovaskularnu podršku.
English: Neutropenia, leukopenia1
Croatian: Neutropenija, leukopenija1
English: The ‘class' reflects the seriousness of the disease: ‘class III' involves marked limitation of physical activity.
Croatian: Stupanj odražava ozbiljnost bolesti: „III. stupanj” uključuje značajna ograničenja fizičke aktivnosti.
English: This card contains important information about STAYVEER.
Croatian: Ova kartica sadrži važne informacije o lijeku STAYVEER.
English: This lowers the blood pressure and relieves the symptoms.
Croatian: Na taj način snižava se krvni tlak i olakšavaju simptomi.
English: You should have a pregnancy test before initiation of STAYVEER and every month during the treatment even if you think that you are not pregnant.
Croatian: Morate napraviti test na trudnoću prije uvođenja STAYVEERA i svaki mjesec tijekom liječenja, iako mislite da niste trudni.
English: Due to limited data in children below 2 years of age, pharmacokinetics remain not well characterised in this age category.
Croatian: Zbog ograničenih podataka za djecu ispod 2 godine starosti, u toj dobnoj skupini farmakokinetika i dalje ostaje nedovoljno opisana.
English: Less than 3% of an administered oral dose is recovered in urine.
Croatian: Manje od 3% primijenjene oralne doze izlučuje se urinom.
English: STAYVEER may harm unborn babies conceived before starting or during treatment.
Croatian: STAYVEER može naškoditi nerođenoj djeci začetoj prije početka ili tijekom liječenja.
English: Tablets are to be taken orally morning and evening, with or without food.
Croatian: Tablete se uzimaju peroralno ujutro i navečer, s ili bez hrane.
English: Uncontrolled clinical studies in paediatric patients
Croatian: Nekontrolirane kliničke studije u pedijatrijskih bolesnika
English: If you are a man taking STAYVEER, it is possible that this medicine may lower your sperm count.
Croatian: Ako ste muškarac i uzimate STAYVEER, moguće je da Vam taj lijek smanji broj spermija.
English: For further details please refer to section 4.5.
Croatian: Za više pojedinosti molimo pogledajte dio 4.5.
English: Anaemia may occasionally require blood transfusion
Croatian: Anemija u nekim slučajevima može zahtijevati transfuziju krvi
English: If you suspect you may be pregnant, tell your doctor or gynaecologist.
Croatian: Ako posumnjate na trudnoću, recite to svom liječniku ili ginekologu.
English: • Abnormal liver function which may affect more than 1 in 10 people
Croatian: • Oštećenje funkcije jetre koje se može pojaviti u više od 1 na 10 osoba
English: • Palpitations (fast or irregular heart beats)
Croatian: • Palpitacije (brzi ili nepravilni otkucaji srca)
English: Monitoring of aminotransferase levels should be continued at least every 2 weeks.
Croatian: Praćenje vrijednosti aminotransferaza treba nastaviti najmanje svaka 2 tjedna.
English: Tell your doctor immediately if you become pregnant while you are taking STAYVEER, or plan to become pregnant in the near future.
Croatian: Odmah recite svom liječniku ako zatrudnite tijekom uzimanja STAYVEERA ili planirate zatrudnjeti u skoroj budućnosti.
English: Haemodynamics were measured in 17 patients.
Croatian: Hemodinamički parametri određeni su u 17 bolesnika.
English: • a pregnancy test if you are a woman of childbearing potential
Croatian: • test na trudnoću ako ste žena reproduktivne dobi
English: For further information see sections 4.5 and 4.6.
Croatian: Za daljnje informacije vidjeti dio 4.5 i 4.6.
English: The clinical benefit of the combination has not been demonstrated.
Croatian: Klinička korist od kombinirane terapije nije pokazana.
English: If you notice any of these signs tell your doctor immediately
Croatian: Ako primijetite bilo koji od ovih znakova odmah recite svom liječniku.
English: The Patient Alert Card, provided as part of the product packaging, aims to:
Croatian: Kartica s upozorenjima za bolesnika, koja je uključena u pakiranje lijeka, ima za cilj:
English: If you take more tablets than you have been told to take, contact your doctor immediately.
Croatian: Ako uzmete više tableta nego što Vam je liječnik propisao, odmah se javite svom liječniku.
English: The majority of patients were diagnosed with idiopathic or heritable PAH (61%).
Croatian: Većina bolesnika imala je dijagnozu idiopatskog ili nasljednog PAH-a (61%).
English: Consequently, it is recommended that patients be monitored for signs of fluid retention (e.g., weight gain), especially if they concomitantly suffer from severe systolic dysfunction.
Croatian: Stoga se preporučuje nadzirati bolesnike s obzirom na znakove zadržavanja tekućine (npr. povećanje tjelesne težine), osobito ako istodobno boluju od teške sistoličke disfunkcije.
English: • inform patients of the need to avoid pregnancy and to ensure effective contraceptive measures are used.
Croatian: • informirati bolesnice o potrebi izbjegavanja trudnoće te korištenja učinkovitih kontracepcijskih metoda.
English: CL = confidence limit; PVR = pulmonary vascular resistance; SD = standard deviation.
Croatian: CL = granica pouzdanosti; PVR = plućni krvožilni otpor; SD = standardna devijacija
English: In the post-marketing period, cases of anaemia requiring red blood cell transfusion have been reported (see section 4.8).
Croatian: U postmarketinškom razdoblju zabilježeni su slučajevi anemije, koji su zahtijevali transfuziju crvenih krvnih stanica (vidjeti dio 4.8).
English: Patients and prescribers must be aware that due to potential pharmacokinetic interactions, STAYVEER may render hormonal contraceptives ineffective (see section 4.5).
Croatian: Bolesnici i liječnici moraju znati da zbog mogućih farmakokinetičkih interakcija STAYVEER može smanjiti učinkovitost hormonskih kontraceptiva (vidjeti dio 4.5).
English: Management in the event of clinical deterioration of PAH
Croatian: Zbrinjavanje u slučaju kliničkog pogoršanja PAH-a
English: The primary endpoint for each study was change in 6-minute walk distance at 12 weeks for the first study and 16 weeks for the second study.
Croatian: Primarna mjera ishoda za svaku studiju bila je promjena u 6-minutnoj postignutoj udaljenosti hodom nakon 12 tjedana za prvu studiju te nakon 16 tjedana za drugu studiju.
English: What STAYVEER looks like and contents of the pack
Croatian: Kako STAYVEER izgleda i sadržaj pakiranja
English: Pharmacotherapeutic group: other antihypertensives, ATC code: C02KX01
Croatian: Farmakoterapijska skupina: ostali antihipertenzivi, ATK oznaka: C02KX01 Mehanizam djelovanja
English: In both studies, treatment with bosentan resulted in significant increases in exercise capacity.
Croatian: U obje studije liječenje bosentanom dovelo je do značajnog povećanja fizičke sposobnosti.
English: Be sure to discuss any questions you may have with your doctor or your gynaecologist - complete the details on the back of this card and take it to your doctor or gynaecologist at your next visit.
Croatian: Raspravite o svim pitanjima koja imate sa svojim liječnikom ili ginekologom - pažljivo ispunite poleđinu ove kartice i pokažite je svom liječniku ili ginekologu prilikom sljedeće posjete.
English: Film-coated tablet (tablets):
Croatian: Filmom obložena tableta (tablete):
English: No recommendation on a posology can be made (see sections 5.1 and 5.2).
Croatian: Nije moguće dati preporuku o doziranju (vidjeti dijelove 5.1 i 5.2).
English: The estimates may have been influenced by the initiation of epoprostenol treatment in 43/235 patients.
Croatian: Na procijenjene vrijednosti vjerojatno je utjecao početak liječenja epoprostenolom u 43/235 bolesnika.
English: Bosentan specifically antagonises ET receptors and does not bind to other receptors.
Croatian: Bosentan specifično antagonistički djeluje na ET-receptore i ne veže se za druge receptore.
English: Based on the investigated range of each variable, it is not expected that the pharmacokinetics of bosentan will be influenced by gender, body weight, race, or age in the adult population to any relevant extent.
Croatian: Na temelju istraženog raspona svake varijable, nije za očekivati da će kod odrasle populacije na farmakokinetiku bosentana značajno utjecati spol, tjelesna težina, rasa ili dob.
English: Control was placebo plus current therapy.
Croatian: Kontrola je bila placebo zajedno s trenutačnom terapijom.
English: Based on these findings and preclinical data, it cannot be excluded that bosentan may have a detrimental effect on spermatogenesis in men.
Croatian: Na temelju tih rezultata i pretkliničkih podataka, ne može se isključiti mogućnost štetnog učinka bosentana na spermatogenezu u muškaraca.
English: However, full induction by bosentan might not have been reached and a further decrease of protease inhibitors cannot be excluded.
Croatian: Međutim, potpuna indukcija bosentanom možda nije bila dosegnuta te stoga nije moguće isključiti daljnje snižavanje inhibitora proteaze.
English: If the decision to withdraw STAYVEER is taken, it should be done gradually while an alternative therapy is introduced.
Croatian: Ukoliko se donijela odluka o ukidanju STAYVEERA, to treba provesti postupno uz uvođenje alternativne terapije.
English: • caused by scleroderma (also called systemic sclerosis, a disease where there is abnormal growth of the connective tissue that supports the skin and other organs);
Croatian: • uzrokovana sklerodermijom (također nazvanom i sistemska skleroza, bolest s abnormalnim rastom vezivnog tkiva koje podržava kožu i druge organe);
English: • simvastatin (used to treat hypercholesterolaemia).
Croatian: • simvastatin (koristi se za liječenje hiperkolesterolemije).
English: Hypersensitivity reactions (including dermatitis, pruritus and rash)2
Croatian: Reakcije preosjetljivosti (uključujući dermatitis, pruritus i osip)2
English: • Neutropenia/leukopenia (low number of white blood cells)
Croatian: • Neutropenija/leukopenija (smanjen broj bijelih krvnih stanica)
English: The Kaplan-Meier estimate of overall survival at 2 years was 91.2%.
Croatian: Kaplan-Meierova procjena ukupnog preživljenja nakon 2 godine bila je 91,2%.
English: In this study, the exposure to bosentan decreased with time in a manner consistent with the known auto-induction properties of bosentan.
Croatian: U ovoj studiji, izloženost bosentanu smanjila se s vremenom u skladu s poznatim autoindukcijskim svojstvima bosentana.
English: Clearance and volume of distribution decrease with increased intravenous doses and increase with time.
Croatian: Klirens i volumen raspodjele smanjuju se s povećanjem intravenskih doza a povećavaju se s vremenom.
English: • other medicines for the treatment of HIV infection, which may require special monitoring if used together with STAYVEER.
Croatian: • druge lijekove za liječenje HIV infekcije koji mogu zahtijevati poseban nadzor ako se koriste zajedno sa STAYVEEROM
English: • fever (high temperature)
Croatian: • vrućicu (povišenu tjelesnu temperaturu)
English: The improvement in walk distance was apparent after 4 weeks of treatment, was clearly evident after 8 weeks of treatment and was maintained for up to 28 weeks of double-blind treatment in a subset of the patient population.
Croatian: Poboljšanje u prijeđenoj udaljenosti bilo je vidljivo nakon 4 tjedna liječenja i jasno uočljivo nakon 8 tjedana liječenja te održano do 28 tjedana dvostruko slijepe studije u dijelu populacije bolesnika.
English: For white high-density polyethylene bottles, use within 30 days after the first opening.
Croatian: Za bijele boce od polietilena visoke gustoće, upotrijebiti unutar 30 dana od prvog otvaranja.
English: Due to the potential for interactions related to the inducing effect of bosentan on CYP450 (see section 4.5), which could affect the efficacy of antiretroviral therapy, these patients should also be monitored carefully regarding their HIV infection.
Croatian: Zbog mogućnosti interakcija, koje su vezane za inducirajući učinak bosentana na CYP450 (vidjeti dio 4.5), a koje mogu utjecati na učinkovitost antiretrovirusne terapije, te bolesnike treba također pažljivo nadzirati s obzirom na kontrolu
English: STAYVEER can be taken with or without food.
Croatian: STAYVEER se može uzimati s hranom ili bez nje.
English: Pharmacokinetics were studied in paediatric patients in 4 clinical studies (BREATHE-3, FUTURE 1, FUTURE-3 and FUTURE-4; see section 5.1).
Croatian: Farmakokinetika u pedijatrijskih bolesnika ispitivana je u 4 kliničke studije (BREATHE-3, FUTURE 1, FUTURE-3 i FUTURE-4; vidjeti dio 5.1).
English: The safety profile in this pooled analysis of uncontrolled paediatric studies was similar to that observed in the pivotal trials in adult patients with PAH except for infections, which were more frequently reported than in adults (69.0% vs 41.3%).
Croatian: Sigurnosni profil u ovoj analizi objedinjenih podataka iz nekontroliranih pedijatrijskih studija bio je sličan onome opaženom u pivotalnim studijama u odraslih bolesnika s PAH-om, osim za infekcije koje su bile češće zabilježene nego u odraslih (69,0% naspram 41,3%).
English: Blurred vision have also been reported at an unknown frequency (frequency cannot be estimated from the available data).
Croatian: Također je zabilježen i zamagljen vid s nepoznatom učestalošću (ne može se procijeniti iz dostupnih podataka).
English: For PVC/PE/PVDC/aluminium-blisters:
Croatian: Za PVC/PE/PVDC/aluminij blistere:
English: The side effects that have been reported in children treated with STAYVEER are the same as those in adults.
Croatian: Nuspojave uočene u djece liječene STAYVEERom iste su kao u odraslih.
English: STAYVEER widens the pulmonary arteries, making it easier for the heart to pump blood through them.
Croatian: STAYVEER širi plućne arterije olakšavajući srcu pumpanje krvi kroz njih.
English: It is recommended that haemoglobin concentrations be checked prior to initiation of treatment, every month during the first 4 months, and quarterly thereafter.
Croatian: Preporučuje se provjeriti koncentracije hemoglobina prije početka liječenja, svaki mjesec tijekom prva 4 mjeseca, a potom svaka 3 mjeseca.
English: The tablets can be taken with or without food.
Croatian: Tablete se mogu uzeti s hranom ili bez nje.
English: This decrease is probably due to auto-induction of metabolising liver enzymes.
Croatian: To smanjenje vjerojatno je uzrokovano autoindukcijom jetrenih enzima za metaboliziranje.
English: > 5 and ≤ 8 × ULN The result should be confirmed by a second liver test; if confirmed, treatment should be stopped and aminotransferase levels monitored at least every 2 weeks.
Croatian: > 5 i ≤ 8 × GGN Nalaz treba potvrditi drugim testom jetrene funkcije; ako je potvrđen, treba prekinuti liječenje i pratiti vrijednosti aminotransferaza najmanje svaka 2 tjedna.
English: If you are a woman who could become pregnant, your doctor will ask you to take a pregnancy test before you start taking STAYVEER, and regularly while you are taking STAYVEER.
Croatian: Ako ste žena koja može zatrudnjeti, Vaš liječnik će tražiti da napravite test na trudnoću prije nego što počnete uzimati STAYVEER te da ga redovito ponavljate tijekom uzimanja STAYVEERA.
English: The educational programme consists of a Patient Alert Card to be held by the patient.
Croatian: Edukacijski program sastoji se od Kartice s upozorenjima za bolesnika koju čuva bolesnik.
English: Background treatments for systemic sclerosis and digital ulcers were permitted if they remained constant for at least 1 month prior to the start of treatment and during the double-blind study period.
Croatian: Dodatni lijekovi za sistemsku sklerozu i ulceracije prstiju bili su dozvoljeni ako su uzimani najmanje 1 mjesec prije početka liječenja i tijekom dvostruko slijepog razdoblja studije.
English: • Primary (idiopathic and heritable) pulmonary arterial hypertension
Croatian: • Primarne (idiopatske i nasljedne) plućne arterijske hipertenzije
English: Animal models
Croatian: Djelotvornost Životinjski modeli
English: The mechanism for this interaction may be induction of P-glycoprotein.
Croatian: Mogući mehanizam te interakcije jest indukcija P-glikoproteina.
English: The requirements for submission of periodic safety update reports including liver reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: • Periodička izvješća o neškodljivosti Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek, uključujući izvješća o utjecaju na funkciju jetre, definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Your doctor or gynaecologist will advise you about reliable contraceptive methods while taking STAYVEER.
Croatian: Vaš liječnik ili ginekolog savjetovat će Vas o sigurnim kontracepcijskim metodama tijekom uzimanja STAYVEERA.
English: There have also been rare reports of liver failure.
Croatian: Također postoje rijetki izvještaji o zatajenju jetre.
English: • Anaemia (low blood value) which may affect up to 1 in 10 people.
Croatian: • Anemija (slabokrvnost) koja se može pojaviti u do 1 na 10 osoba.
English: At the same timepoints, 88% and 79% of patients remained free from PAH worsening (defined as all-cause death, lung transplantation, atrial septostomy or start of intravenous or subcutaneous prostanoid treatment).
Croatian: U istim vremenskim razdobljima, kod 88% i 79% bolesnika nije došlo do pogoršanja PAH-a (definiranog kao smrtnost iz svih uzroka, transplantacija pluća, atrijalna septostomija ili početak intravenoznog ili supkutanog prostanoidnog liječenja).
English: There are no reliable data on the use of STAYVEER in pregnant women.
Croatian: Nema pouzdanih podataka o primjeni STAYVEERA kod trudnica.
English: You are advised to stop breast-feeding if STAYVEER is prescribed for you, because it is not known whether this medicine passes into breast milk.
Croatian: Prekinite s dojenjem ako Vam je propisan STAYVEER jer nije poznato prelazi li ovaj lijek u majčino mlijeko.
English: OUTER CARTON/BLISTERS
Croatian: KUTIJA/BLISTERI
English: This metabolite is mainly excreted unchanged via the bile.
Croatian: Ovaj metabolit uglavnom se izlučuje nepromijenjen putem žuči.