FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor immediately if you are breast-feeding.
Croatian: Odmah recite svom liječniku ako dojite.
English: The most serious side effects with STAYVEER are
Croatian: Najozbiljnije nuspojave STAYVEERA su:
English: If a clinically relevant decrease in haemoglobin concentration occurs, further evaluation and investigation should be undertaken to determine the cause and need for specific treatment.
Croatian: Ako dođe do klinički značajnog smanjenja koncentracije hemoglobina, treba odrediti njegov uzrok te potrebu za specifičnim liječenjem.
English: Do not use this medicine after the expiry date which is stated on the carton and on the blister after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji ili blisteru iza oznake „EXP“”.
English: Some patients not responding well to 125 mg twice daily of STAYVEER may slightly improve their exercise capacity when the dose is increased to 250 mg twice daily.
Croatian: Kod nekih bolesnika koji ne reagiraju dobro na 125 mg STAYVEERA dvaput dnevno, može doći do blagog poboljšanja kapaciteta fizičkog opterećenja kada se doza poveća na 250 mg dvaput dnevno.
English: Tablets should be taken (morning and evening), swallowed with water.
Croatian: Tablete treba uzeti ujutro i navečer s vodom.
English: Patients were divided into three body-weight groups and dosed with bosentan at approximately 2 mg/kg twice daily for 12 weeks.
Croatian: Bolesnici su podijeljeni u tri skupine s obzirom na tjelesnu težinu i dobivali su bosentan u dozi od otprilike 2 mg/kg dvaput dnevno tijekom 12 tjedana.
English: The Kaplan-Meier event-free estimate for worsening of PAH (death, lung transplantation, or hospitalisation for PAH worsening) at 24 weeks was 96.9% and 96.7% in the twice daily and three times daily groups, respectively.
Croatian: KaplanMeierova procjena preživljenja bez događaja pogoršanja PAH-a (smrt, transplantacija pluća ili hospitalizacija zbog pogoršanja PAH-a) nakon 24 tjedna bila je 96,9% u skupini koja je lijek primala dvaput dnevno i 96,7% u skupini koja je lijek primala triput dnevno.
English: Both glibenclamide and bosentan inhibit the bile salt export pump, which could explain the elevated aminotransferases.
Croatian: Oba lijeka, glibenklamid i bosentan inhibiraju crpku za izlučivanje žučnih soli, što može objasniti povišene aminotransferaze.
English: Therefore, hormonebased contraceptives alone, regardless of the route of administration (i.e., oral, injectable, transdermal or implantable forms), are not considered as reliable methods of contraception (see sections 4.4 and
Croatian: Stoga se sami hormonski kontraceptivi, neovisno o putu primjene (tj. u oralnom, injekcijskom, transdermalnom ili implantacijskom obliku) ne smatraju pouzdanom metodom kontracepcije (vidjeti dijelove 4.4 i 4.6).
English: Bosentan has been shown to be teratogenic in rats at plasma levels higher than 1.5 times the plasma concentrations achieved at the therapeutic dose in humans.
Croatian: Bosentan je teratogen u štakora kod koncentracija u plazmi koje su 1,5 puta veće od onih koje se postižu kod terapijskih doza u ljudi.
English: OUTER CARTON & BOTTLE LABEL/ BOTTLES
Croatian: KUTIJA I NALJEPNICA BOCE/BOCE
English: No dose adjustment is required in patients undergoing dialysis (see section 5.2).
Croatian: Prilagođavanje doze nije potrebno kod pacijenata na dijalizi (vidjeti dio 5.2).
English: Concomitant use of rifampicin and STAYVEER is not recommended.
Croatian: Istodobna primjena rifampicina i STAYVEERA nije preporučljiva.
English: Studies in animals have shown reproductive toxicity (teratogenicity, embryotoxicity; see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su reproduktivnu toksičnost (teratogenost, embriotoksičnost;
English: • Baseline values of liver aminotransferases, i.e., aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT), greater than 3 × the upper limit of normal (ULN; see section 4.4)
Croatian: • Početne vrijednosti jetrenih aminotransferaza, tj. aspartat-aminotransferaze (AST) i/ili alanin-aminotransferaze (ALT), 3 × veće od gornje granice normalnih vrijednosti (GGN; vidjeti dio 4.4) • Istovremena primjena ciklosporina A (vidjeti dio 4.5)
English: The combination should be used with caution.
Croatian: Kod istodobne primjene potreban je oprez.
English: Treatment with bosentan led to a significant increase in cardiac index associated with a significant reduction in pulmonary artery pressure, pulmonary vascular resistance and mean right atrial pressure.
Croatian: Liječenje bosentanom dovelo je do značajnog povećanja srčanog indeksa sa značajnim smanjenjem plućnog arterijskog tlaka, plućnog krvožilnog otpora i srednjeg tlaka u desnom atriju.
English: After 4 weeks of bosentan 62.5 mg twice daily, the maintenance doses studied in these studies were 125 mg twice daily in AC-052-351, and 125 mg twice daily and 250 mg twice daily in AC-052-352.
Croatian: Nakon 4 tjedna uzimanja bosentana 62,5 mg dvaput dnevno doze održavanja u tim studijama bile su 125 mg dvaput dnevno u AC-052-351, 125 mg dvaput dnevno i 250 mg dvaput dnevno u AC-052-352.
English: Syncope1, 4
Croatian: Sinkopa1,4
English: Safety and tolerability of bosentan was investigated in an exploratory, uncontrolled 12-week study in 11 patients with pulmonary hypertension secondary to severe COPD (stage III of GOLD classification).
Croatian: Sigurnost i podnošljivost bosentana ispitana je u eksploratornoj, nekontroliranoj 12-tjednoj studiji na 11 bolesnika s plućnom hipertenzijom kao posljedicom teške kronične opstruktivne plućne bolesti (stadij III prema klasifikaciji GOLD).
English: Patients with suboptimal response to inhaled nitric oxide (iNO) despite at least 4 hours of continuous treatment were treated with bosentan dispersible tablets at 2 mg/kg twice daily (N = 13) or placebo (N = 8) via nasogastric tube as add-on therapy on top of iNO until complete weaning of iNO or until treatment failure (defined as need for extra-corporeal membrane oxygenation [ECMO] or initiation of alternative pulmonary vasodilator), and for a maximum of 14 days.
Croatian: Bolesnici sa suboptimalnim odgovorom na udisanje dušikovog (II) oksida (engl. inhaled nitric oxide, iNO) unatoč najmanje 4 sata neprekinutog liječenja, liječeni su bosentanom u obliku tableta za oralnu suspenziju u dozi od 2 mg/kg dvaput dnevno (N = 13) ili placebom (N = 8) putem nazogastrične sonde kao dodatnom terapijom uz iNO sve do potpunog odvikavanja od iNO ili do terapijskog neuspjeha (definiranog kao potreba za ekstrakorporalnom membranskom oksigenacijom [ECMO] ili uvođenjem alternativnog pulmonalnog vazodilatatora) i to najdulje 14 dana.
English: • Headache • Oedema (swelling of the legs and ankles or other signs of fluid retention)
Croatian: • Edem (oticanje nogu i gležnjeva ili drugi znakovi zadržavanja tekućine)
English: AC-052-356 was an open-label, uncontrolled study; 10 of the 19 paediatric patients were on concomitant bosentan and epoprostenol therapy during the 12week study.
Croatian: AC-052-356 bila je otvorena, nekontrolirana studija; 10 od 19 pedijatrijskih bolesnika istodobno su dobivali bosentan i epoprostenol tijekom 12 tjedana.
English: STAYVEER is contraindicated in patients with moderate to severe liver dysfunction (see sections 4.3, 4.4 and 5.2).
Croatian: STAYVEER je kontraindiciran kod bolesnika s umjerenom do teškom disfunkcijom jetre (vidjeti dijelove 4.3, 4.4 i 5.2).
English: Controlled clinical study experience in this indication is limited to 6 months (see section 5.1).
Croatian: Iskustvo vezano uz ovu indikaciju ograničeno je šestomjesečnim trajanjem kontrolirane kliničke studije (vidjeti dio 5.1).
English: The mean increase from baseline in cardiac index was 0.5 L/min/m2, the mean decrease in mean pulmonary arterial pressure was 8 mmHg, and the mean decrease in PVR was 389 dyn·sec·cm-5.
Croatian: Prosječno povećanje srčanog indeksa u odnosu na početnu vrijednost bilo je 0,5 l/min/m2, prosječno smanjenje srednjeg plućnog arterijskog tlaka bilo je 8 mmHg, a prosječno smanjenje plućnog krvožilnog otpora bilo je 389 dyn•s•cm-5.
English: After 16 weeks' treatment, there were significant improvements from baseline in exercise capacity: the mean increase in 6-minute walk distance was 91.4 metres from 332.6 metres on average at baseline (p < 0.001).
Croatian: Nakon 16 tjedana liječenja došlo je do znatnog poboljšanja fizičke sposobnosti u odnosu na početnu vrijednost: srednje povećanje tijekom 6-minutne postignute udaljenosti hodom bilo je 91,4 metra u odnosu na 332,6 metara koja čine prosječnu prijeđenu udaljenost prije liječenja (p<0,001).
English: Fluconazole and other inhibitors of both CYP2C9 and CYP3A4: Co-administration with fluconazole, which inhibits mainly CYP2C9, but to some extent also CYP3A4, could lead to large increases in plasma concentrations of bosentan.
Croatian: Flukonazol i drugi inhibitori i CYP2C9 i CYP3A4: istodobna primjena flukonazola, koji uglavnom inhibira CYP2C9, ali do neke mjere i CYP3A4, može dovesti do velikog povećanja koncentracije bosentana u plazmi.
English: An open-label, non-comparative study (AC-052-362 [BREATHE-4]) was performed in 16 patients with WHO functional class III PAH associated with HIV infection.
Croatian: Otvorena, nekomparativna studija (AC-052-362 [BREATHE-4]) provedena je na 16 bolesnika s PAH-om WHO funkcionalnog stupnja III povezanim s HIV-infekcijom.
English: The blood concentrations of cyclosporine A (a CYP3A4 substrate) decreased by approximately 50%.
Croatian: Koncentracije ciklosporina A u krvi (supstrat za CYP3A4) bile su smanjenje za približno 50%.
English: Bosentan film-coated tablets were evaluated in an open-label uncontrolled study in 19 paediatric patients with PAH aged 3 to 15 years.
Croatian: Bosentan u obliku filmom obloženih tableta procijenjen je u otvorenoj nekontroliranoj studiji na 19 pedijatrijskih bolesnika s PAH-om u dobi od 3 do 15 godina.
English: This combination should not be used.
Croatian: Stoga se ta kombinacija lijekova ne smije uzimati.
English: Elevations in aminotransferases were associated with elevated bilirubin (≥ 2 × ULN) without evidence of biliary obstruction in 0.2% (5 patients) on bosentan and 0.3% (6 patients) on placebo.
Croatian: Povećanje aminotransferaza bilo je povezano s povećanjem bilirubina (≥ 2 × GGN) bez dokaza opstrukcije žuči u 0,2% (5 bolesnika) koji su dobivali bosentan i 0,3% (6 bolesnika) koji su dobivali placebo.
English: Slightly increased incidence of testicular tubular atrophy was observed in rats given bosentan orally at doses as low as 125 mg/kg/day (about 4 times the maximum recommended human dose [MRHD] and the lowest doses tested) for two years but not at doses as high as 1,500 mg/kg/day (about 50 times the MRHD) for 6 months.
Croatian: Uočena je lagano povećana incidencija tubularne atrofije testisa u štakora koji su primali bosentan peroralno u niskim dozama od 125 mg/kg/dan (otprilike 4 puta više od maksimalne preporučene doze za ljude [MRHD, engl. maximum recommended human dose] i najniža ispitivana doza) tijekom dvije godine, ali ne i pri visokim dozama od 1500 mg/kg/dan (otprilike 50 puta više od MRHD)
English: Appropriate precautions must be taken for women of childbearing potential (see sections 4.3, 4.4 and 4.6).
Croatian: U žena reproduktivne dobi treba poduzeti odgovarajuće mjere opreza (vidjeti dijelove 4.3, 4.4 i 4.6).
English: STAYVEER is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease (see section 5.1).
Croatian: STAYVEER je također indiciran za smanjenje broja novih ulceracija na prstima kod bolesnika sa sistemskom sklerozom i aktivnom bolešću ulceracija prstiju (vidjeti dio 5.1).
English: Enrolled patients were PAH-treatment-naïve (n = 156) or on a stable dose of sildenafil (n = 29).
Croatian: Uključeni bolesnici do tada nisu dobivali terapiju za PAH (n = 156) ili su dobivali stalnu dozu sildenafila (n = 29).
English: The treatment in adults is usually started for the first 4 weeks with 62.5 mg twice daily (morning and evening), from then your doctor will usually advise you to take a 125 mg tablet twice daily, depending on how you react to STAYVEER.
Croatian: Liječenje odraslih bolesnika obično započinje tijekom prva 4 tjedna dozom od 62,5 mg dva puta dnevno (ujutro i navečer), a potom će Vam liječnik vjerojatno savjetovati da uzimate 125 mg dva puta dnevno, ovisno o Vašoj reakciji na STAYVEER.
English: Therefore, if you use hormonal contraceptives you must also use a barrier method (e.g., female condom, diaphragm, contraceptive sponge, or your partner must also use a condom).
Croatian: Stoga, ako koristite hormonsku kontracepciju, ujedno morate koristiti i metodu barijere (npr. ženski kondom, dijafragmu, kontracepcijsku spužvu ili
English: At baseline in FUTURE 1, 9 patients were taking epoprostenol.
Croatian: Na početku FUTURE 1 studije, 9 bolesnika je uzimalo epoprostenol.
English: In the post-marketing period rare cases of unexplained hepatic cirrhosis were reported after prolonged therapy with STAYVEER in patients with multiple co-morbidities and therapies with medicinal products.
Croatian: U postmarketinškom razdoblju prijavljeni su rijetki slučajevi neobjašnjive ciroze jetre nakon produljene terapije STAYVEEROM u bolesnika s višestrukim istodobnim pobolijevanjima i terapijama lijekovima.
English: The safety profile in the first paediatric uncontrolled study performed with the film-coated tablet (BREATHE-3: n = 19, median age 10 years [range 3-15 years], open-label bosentan 2 mg/kg twice daily; treatment duration 12 weeks) was similar to that observed in the pivotal trials in adult patients with PAH.
Croatian: Sigurnosni profil u prvoj nekontroliranoj pedijatrijskoj studiji provedenoj s filmom obloženom tabletom (BREATHE-3: n = 19, medijan dobi 10 godina [raspon 3-15 godina], otvoreno davanje bosentana 2 mg/kg dvaput dnevno; trajanje liječenja 12 tjedana) bio je sličan kao kod pivotalnih studija odraslih bolesnika s PAH-om.
English: The mean pulmonary vascular resistance was significantly reduced in the bosentan group (with a predominant effect observed in the subgroup of patients with bidirectional intracardiac shunt).
Croatian: Srednji plućni krvožilni otpor bio je značajno manji u skupini koja je dobivala bosentan (najveći učinak primijećen je u podskupini bolesnika koji su imali dvosmjerni unutarsrčani šant).
English: At baseline, patients had idiopathic (31 patients [86%]) or familial (5 patients [14%]) PAH, and were in WHO functional class II (n = 23, 64%) or class III (n = 13, 36%).
Croatian: Na početku studije, bolesnici su imali idiopatski (31 bolesnik [86%]) ili obiteljski (5 bolesnika [14%]) PAH i bili su funkcionalnog stupnja II (n = 23, 64%) ili III (n = 13, 36%) prema WHO.
English: He had symptoms of nausea, vomiting, hypotension, dizziness, sweating and blurred vision.
Croatian: Imao je simptome mučnine, povraćanja, hipotenzije, vrtoglavice,
English: • Pulmonary arterial hypertension associated with congenital systemic-to-pulmonary shunts and
Croatian: • Plućne arterijske hipertenzije povezane s kongenitalnim sistemsko-plućnim šantom i
English: STAYVEER 62.5 mg film-coated tablets EU/1/13/832/001
Croatian: STAYVEER 62,5 mg filmom obložene tablete EU/1/13/832/001
English: It is important that you have these tests as ordered by your doctor.
Croatian: Važno je da provodite sve pretrage prema uputama liječnika.
English: Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172) Ethylcellulose
Croatian: Film ovojnica: hipromeloza gliceroltriacetat talk titanijev dioksid (E171) željezov oksid žuti (E172) željezov oksid crveni (E172) etilceluloza
English: Adverse reactions observed in 20 placebo-controlled studies and post-marketing experience with bosentan are ranked according to frequency using the following convention: very common (≥ 1/10); common (≥1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Croatian: (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: If you forget to take STAYVEER
Croatian: Ako ste zaboravili uzeti STAYVEER
English: When treatment with STAYVEER is initiated in patients who require ritonavir-boosted protease inhibitors, the patient's tolerability of STAYVEER should be closely monitored with special attention, at the beginning of the initiation phase, to the risk of hypotension and to liver function tests.
Croatian: Kada je terapija STAYVEEROM započeta kod bolesnika koji zahtijevaju liječenje ritonavirom - inhibitorom proteaze, bolesnikovu podnošljivost STAYVEERA treba pomno pratiti s posebnom pažnjom na početku faze uvođenja, s obzirom na rizik od hipotenzije i nalaze funkcije jetre.
English: years to 11 years old, 15 (23.4%) were between 1 and 2 years old, and 6 (9.4%) were between 3 months and 1 year old.
Croatian: 43 (67,2%) ih je bilo ≥ 2 do 11 godina starosti, 15 (23,4%) ih je bilo između 1 i 2 godine starosti te njih 6 (9,4%) bilo je staro između 3 mjeseca i 1 godine.
English: In this study, fluid retention was manifested by early weight gain, decreased haemoglobin concentration and increased incidence of leg oedema.
Croatian: U toj studiji zadržavanje tekućine odrazilo se putem ranog povećanja tjelesne težine, smanjenja koncentracije hemoglobina i povećane učestalosti edema nogu.
English: Bosentan decreases both pulmonary and systemic vascular resistance resulting in increased cardiac output without increasing heart rate.
Croatian: Bosentan smanjuje plućni i sistemski krvožilni otpor te tako povećava minutni volumen srca bez povećanja srčane frekvencije.
English: Blood tests for anaemia
Croatian: Krvne pretrage za anemiju
English: Pulmonary hypertension secondary to chronic obstructive pulmonary disease (COPD)
Croatian: Plućna hipertenzija kao posljedica kronične opstruktivne plućne bolesti (KOPB)
English: The most frequent adverse events in the bosentan- and placebo-treated patients were, respectively, anaemia or haemoglobin decrease (7 and 2 patients), generalised oedema (3 and 0 patients), and vomiting (2 and 0 patients).
Croatian: Najčešći štetni događaji u bolesnika koji su primali bosentan i placebo bili su: anemija ili smanjenje razine hemoglobina (u 7 odnosno 2 bolesnika), generalizirani edem (u 3 odnosno 0 bolesnika) i povraćanje (u 2 odnosno 0 bolesnika).
English: STAYVEER may harm the development of the foetus.
Croatian: Lijek STAYVEER može naškoditi razvoju fetusa.
English: The mechanism of this interaction is most likely inhibition of transport protein-mediated uptake of bosentan into hepatocytes by cyclosporine.
Croatian: Najvjerojatnije je mehanizam te interakcije inhibicija ciklosporinom transportnog proteina kojim se bosentan unosi u hepatocite.
English: Gastrooesophageal reflux disease Diarrhoea
Croatian: Gastroezofagealna refluksna bolest
English: Paediatric pharmacokinetic data have shown that bosentan plasma concentrations in children with PAH aged from 1 year to 15 years were on average lower than in adult patients and were not increased by increasing the dose of STAYVEER above 2 mg/kg body weight or by increasing the dosing frequency from twice daily to three times daily (see section 5.2).
Croatian: Pedijatrijski farmakokinetički podaci pokazali su da su koncentracije bosentana u plazmi kod djece s PAH-om u dobi od 1 do 15 godina u prosjeku bile niže nego kod odraslih bolesnika i nisu se povećale povećanjem doze STAYVEERA iznad 2 mg/kg tjelesne težine ili povećanjem učestalosti doziranja s dvaput dnevno na triput dnevno (vidjeti dio 5.2).
English: Before the initiation of STAYVEER treatment in women of childbearing potential, the absence of pregnancy should be checked, appropriate advice on reliable methods of contraception provided, and reliable contraception initiated.
Croatian: Prije početka liječenja STAYVEEROM žena reproduktivne dobi treba provjeriti da nisu trudne, dati im odgovarajuće savjete o pouzdanim metodama kontracepcije i inicirati pouzdanu kontracepciju.
English: Adverse reactions were defined as events occurring in at least 1% of patients on bosentan and at a frequency at least 0.5% more than on placebo.
Croatian: Nuspojave su definirane kao reakcije koje su se pojavile kod najmanje 1% bolesnika koji su dobivali bosentan i s učestalošću od najmanje 0,5% više nego kod onih koji su dobivali placebo.
English: • Pulmonary arterial hypertension secondary to scleroderma without significant interstitial pulmonary disease
Croatian: • Plućne arterijske hipertenzije koja se javlja kao posljedica sklerodermije bez značajne intersticijske plućne bolesti
English: STAYVEER contains sodium
Croatian: STAYVEER sadrži natrij
English: Study AC-052-356 (BREATHE-3) evaluated the pharmacokinetics of single and multiple oral doses of the film-coated tablet formulation of bosentan in 19 children aged from 3 to 15 years with PAH who were dosed on the basis of body weight with 2 mg/kg twice daily.
Croatian: Studija AC-052-356 (BREATHE-3) procijenila je farmakokinetiku pojedinačnih i višekratnih oralnih doza bosentana u obliku filmom obloženih tableta u 19 djece u dobi od 3 do 15 godina s PAH-om koji su dobivali dozu na temelju njihove tjelesne težine od 2 mg/kg dvaput dnevno.
English: Blurred vision1
Croatian: Zamagljen vid1
English: Survival estimates were lower in the subgroup of patients with PAH secondary to systemic sclerosis.
Croatian: Procjena preživljenja bila je niža u podskupini bolesnika koji su imali PAH usporedno sa sistemskom sklerozom.
English: There was one hospitalisation related to PAH worsening in the bosentan group and three hospitalisations in the placebo group.
Croatian: U skupini koja je dobivala bosentan došlo je do jedne hospitalizacije zbog pogoršanja PAH-a te do tri hospitalizacije u skupini koja je dobivala placebo.
English: • cyclosporine A (a medicine used after transplants and to treat psoriasis), which must not be used together with STAYVEER.
Croatian: • ciklosporin A (lijek koji se uzima nakon transplantacije i za liječenje psorijaze) koji se ne smije koristiti zajedno sa STAYVEEROM
English: The treatment effect was driven by improvement in the component symptomatic progression.
Croatian: Učinkovitost liječenja zasnivala se ponajviše na smanjenju napredovanja simptoma.
English: • The median time to complete weaning from iNO was 3.7 days (95% confidence limits [CLs] 1.17, 6.95) on bosentan and 2.9 days (95% CLs 1.26, 4.23) on placebo (p = 0.34).
Croatian: • Medijan vremena do potpunog odvikavanja od iNO bio je 3,7 dana (95% granice sigurnosti [CL] 1,17; 6,95) uz bosentan i 2,9 dana (95% CL 1,26; 4,23) uz placebo (p = 0,34).
English: The pharmacokinetics of bosentan have not been studied in patients with Child-Pugh class C hepatic impairment.
Croatian: Farmakokinetika bosentana nije ispitivana u bolesnika sa smanjenjem jetrene funkcije Child-Pugh stadij C.
English: The number of new digital ulcers from baseline to study endpoint was a primary endpoint in both studies.
Croatian: Broj novih ulceracija prstiju na kraju liječenja u odnosu na početak liječenja bio je primarna mjera ishoda za obje studije.
English: Clinical experience with concomitant administration of bosentan with warfarin in patients with PAH did not result in clinically relevant changes in International Normalized Ratio (INR) or warfarin dose (baseline versus end of the clinical studies).
Croatian: Tijekom kliničkih studija istodobne primjene bosentana i varfarina u bolesnika s PAH-om nije došlo do klinički značajnih promjena internacionalnog normaliziranog omjera (INR) ili doze varfarina (između početne i krajnje vrijednosti u kliničkim studijama).
English: There are no studies to demonstrate beneficial effects of STAYVEER treatment on survival.
Croatian: Ne postoje studije koje bi pokazale povoljno djelovanje liječenja STAYVEEROM na preživljenje bolesnika.
English: STAYVEER is not recommended in paediatric patients with systemic sclerosis and ongoing digital ulcer disease.
Croatian: STAYVEER se ne preporučuje pedijatrijskim bolesnicima sa sistemskom sklerozom i prisutnim ulceracijama na prstima.
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava Često