natgillin/translations-raw huggingface dataset:
The average exposure to bosentan in these paediatric patients was about half the exposure in adult patients at the 125 mg twice daily maintenance dose but showed a large overlap with the exposures in adults. 
Povprečna izpostavljenost bosentanu pri teh bolnikih je bila približno polovica izpostavljenosti odraslih bolnikov z vzdrževalnim odmerkom 125 mg dvakrat na dan, vendar je kazala veliko prekrivanje z izpostavljenostjo pri odraslih.
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). 
Klinične izkušnje s sočasno uporabo bosentana in varfarina pri bolnikih s PAH niso pokazale klinično pomembnih sprememb v mednarodnem normaliziranem razmerju (INRInternational Normalized Ratio) ali odmerku varfarina (izhodiščna vrednost v primerjavi z vrednostjo na koncu kliničnih študij).
Based on these pharmacokinetic results, when used in children with PAH aged 1 year and older, the recommended starting and maintenance dose is 2 mg/kg morning and evening. 
Na podlagi teh farmakokinetičnih rezultatov pri uporabi pri otrocih s PAH, starih 1 leto in več, je priporočeni začetni in vzdrževalni odmerek 2 mg/kg zjutraj in zvečer.
• Women of childbearing potential who are not using reliable methods of contraception (see sections 4.4, 4.5 and 4.6) 
• ženske v rodni dobi, ki ne uporabljajo zanesljivih metod kontracepcije (glejte poglavja 4.4, 4.5 in 4.6)
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%). 
Med najpogostejšimi neželenimi učinki so bile okužbe zgornjih dihal (25 %), pljučna (arterijska) hipertenzija (20 %), nazofaringitis (17 %), pireksija (15 %), bruhanje (13 %), bronhitis (10 %), bolečine v trebuhu (10 %) in driska (10 %).
The blood concentrations of cyclosporine A (a CYP3A4 substrate) decreased by approximately 50%. 
Koncentracije ciklosporina A (substrat CYP3A4) v krvi so se znižale za približno 50 %.
In the post-marketing period there was one reported overdose of 10,000 mg of bosentan taken by an adolescent male patient. 
V obdobju po začetku trženja so poročali o enem primeru prevelikega odmerjanja bosentana (10.000 mg) pri mladoletnem moškem.
Patients should be advised not to swallow the desiccant found in the white high-density polyethylene bottles. 
Bolnike je treba opozoriti, da sušilnega sredstva, ki ga najdejo v belih plastenkah iz polietilena visoke gostote, ne smejo zaužiti.
• Primary (idiopathic and heritable) pulmonary arterial hypertension 
• primarni (idiopatski in podedovani) pljučni arterijski hipertenziji,
Patients in need of the combination should be closely monitored for adverse events related to STAYVEER and for tacrolimus and sirolimus blood concentrations. 
Bolnike, ki to kombinacijo potrebujejo, je treba pazljivo opazovati glede neželenih dogodkov, povezanih z zdravilom STAYVEER, in spremljati koncentracije takrolimusa in sirolimusa v krvi.
Upon multiple dosing, plasma concentrations of bosentan decrease gradually to 50-65% of those seen after single dose administration. 
Po večkratnem odmerjanju se plazemske koncentracije bosentana postopoma znižajo na 50-65 % koncentracij po enkratnem odmerku.
Because of possible hormonal contraception failure during STAYVEER treatment, and also bearing in mind the risk that pulmonary hypertension severely deteriorates with pregnancy, monthly pregnancy tests during treatment with STAYVEER are recommended to allow early detection of pregnancy. 
Zaradi možne odpovedi hormonske kontracepcije v času zdravljenja z zdravilom STAYVEER in ob upoštevanju tveganja, da se pljučna hipertenzija z nosečnostjo hudo poslabša, se v času zdravljenja z zdravilom STAYVEER priporočajo mesečni testi nosečnosti za zgodnje odkrivanje nosečnosti.
After co-administration of bosentan for 9.5 days, the plasma exposures to lopinavir and ritonavir decreased to a clinically non-significant extent (by approximately 14% and 17%, respectively). 
Po 9,5-dnevnem sočasnem dajanju bosentana se je izpostavljenost lopinavirju in ritonavirju v plazmi zmanjšala na klinično nepomembno raven (za približno 14 % oz. 17 %).
In vitro data also suggest an induction of CYP2C19. 
Podatki in vitro kažejo tudi indukcijo CYP2C19.
Pregnancy tests 
Testi nosečnosti
The placebo-corrected increases in walk distance compared with baseline were 76 metres (p = 0.02; t-test) and 44 metres (p = 0.0002; Mann-Whitney U test) at the primary endpoint of each study, respectively. 
Za placebo popravljeno podaljšanje prehojene razdalje v primerjavi z izhodiščno vrednostjo je bilo 76 metrov (p = 0,02; t-test) za prvo študijo oziroma 44 metrov (p = 0,0002; Mann-Whitney U test) za drugo študijo.
The duration of double-blind therapy was 16 weeks in study AC-052-401, and 24 weeks in study AC-052-331. 
Dvojno slepa terapija je v študiji AC-052-401 trajala 16 tednov in v študiji AC-052-331 24 tednov.
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. 
Povprečno trajanje izpostavljenosti zdravljenju z bosentanom je bilo 3,6 ± 1,8 let (do 6,1 let), pri čemer je bilo 73 % bolnikov zdravljenih vsaj 3 leta in 62 % vsaj 4 leta.
Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO functional class III. 
Zdravljenje pljučne arterijske hipertenzije (PAH - Pulmonary Arterial Hypertension), da bi se izboljšala fizična zmogljivost in simptomi pri bolnikih s III. funkcijskim razredom po SZO.
• caused by congenital (inborn) heart defects with shunts (abnormal passageways) causing abnormal flow of blood through the heart and lungs. 
• posledica kongenitalne (prirojene) napake srca s šanti (nenormalni prehodi), ki povzroča nenormalen pretok krvi skozi srce in pljuča.
CL = confidence limit; PVR = pulmonary vascular resistance; SD = standard deviation. 
MZ = meja zaupanja PŽU = pljučno-žilni upor, SD = standardna deviacija
There have also been rare reports of liver failure. 
Obstajajo tudi redka poročila o jetrni odpovedi.
Contents of the pack and other information What STAYVEER contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo STAYVEER
The treatment effect was driven by improvement in the component symptomatic progression. 
Vodilo učinkov zdravljenja je bilo izboljšanje napredovanja posameznih simptomov.
PVR (dyn.sec/cm5) 
PŽU (din.s/cm5)
These elevations in aminotransferases may reverse spontaneously while continuing treatment with the maintenance dose of STAYVEER or after dose reduction, but interruption or cessation may be necessary (see section 4.4). 
Povišane vrednosti aminotransferaz se lahko spontano znižajo z nadaljevanjem zdravljenja z vzdrževalnim odmerkom zdravila STAYVEER ali po znižanju odmerka, vendar je možno, da bo treba zdravljenje prekiniti ali z njim prenehati (glejte poglavje 4.4).
In addition, the frequency of changes in warfarin dose during the studies due to changes in INR or due to adverse events was similar among bosentan- and placebo-treated patients. 
Poleg tega je bila med študijami pogostnost sprememb odmerka varfarina zaradi sprememb INR ali zaradi neželenih dogodkov podobna pri bolnikih, ki so jemali bosentan, in pri bolnikih, ki so prejemali placebo.
• Digital ulcers: (sores on the fingers and toes) in adult patients with a condition called scleroderma. 
• Razjed prstov (rane na prstih rok in nog) pri odraslih bolnikih z boleznijo, imenovano skleroderma.
Pulmonary hypertension secondary to chronic obstructive pulmonary disease (COPD) 
Pljučna hipertenzija sekundarno h kronični obstruktivni pljučni bolezni (KOPB)
FUTURE 3/Extension, elevations in liver aminotransferases ≥ 3 × ULN were observed in 2% of patients. 
in FUTURE 3/podaljšanje, so povišane vrednosti jetrnih aminotransferaz ≥ 3 × ZMN opazili pri 2 %
Treatment with bosentan led to a WHO functional class improvement in 42.4% of patients (placebo 30.4%). 
Zdravljenje z bosentanom je pri 42,4 % bolnikov povzročilo izboljšanje funkcijskega razreda po klasifikaciji SZO (placebo 30,4 %).
Elevations in liver aminotransferases, i.e., aspartate and alanine aminotransferases (AST and/or ALT), associated with bosentan are dose dependent. 
Zvišane vrednosti jetrnih aminotransferaz, tj. aspartat-aminotransferaze in alanin-aminotransferaze (AST in/ali ALT), povezane z bosentanom, so odvisne od odmerka.
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. 
Zvišanja aminotransferaz so bila povezana z zvišanjem bilirubina (≥ 2 × ZMN) brez znakov biliarne obstrukcije pri 0,2 % (5 bolnikih) na bosentanu in 0,3 % (6 bolnikov) na placebu.
As a result, a significantly reduced effect of bosentan is expected when it is co-administered with rifampicin. 
Posledično se pričakuje ob sočasnem dajanju bosentana z rifampicinom pomembno manjši učinek bosentana.
After an increase in dose an additional test will be done after 2 weeks. 
Po povečanju odmerka se dodatna preiskava opravi po 2 tednih.
The overall change in WHO functional class during both studies was significantly better among bosentan-treated patients as compared with placebo-treated patients. 
Skupna sprememba funkcijskega razreda po klasifikaciji Svetovne zdravstvene organizacije v obeh študijah je bila pomembno boljša med bolniki, ki so jemali bosentan, kot pri bolnikih, ki so prejemali placebo.
The educational programme consists of a Patient Alert Card to be held by the patient. 
Izobraževalni program obsega opozorilno kartico za bolnika, ki jo ima bolnik pri sebi.
Liver dysfunction risk may also be increased when medicinal products that are inhibitors of the bile salt export pump, e.g., rifampicin, glibenclamide and cyclosporine A (see sections 4.3 and 4.5), are co-administered with bosentan, but limited data are available. 
Tveganje okvare delovanja jeter se lahko poveča tudi, kadar sočasno z bosentanom dajemo zdravila, ki so zaviralci črpalke žolčnih soli, denimo, rifampicin, glibenklamid in ciklosporin A (glejte poglavji 4.3 in 4.5), vendar so o tem na voljo le omejeni podatki.
Studies performed in children with pulmonary arterial hypertension 
Študije pri otrocih s pljučno arterijsko hipertenzijo
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. 
Pred začetkom zdravljenja z zdravilom STAYVEER in vsak mesec med zdravljenjem opravite test nosečnosti, tudi če menite, da niste noseči.
If you take more tablets than you have been told to take, contact your doctor immediately. 
Če ste vzeli večji odmerek zdravila STAYVEER, kot bi smeli Če ste vzeli več tablet, kot vam je bilo naročeno, takoj pokličite zdravnika.
The side effects that have been reported in children treated with STAYVEER are the same as those in adults. 
Neželeni učinki pri otrocih in mladostnikih Neželeni učinki, o katerih so poročali pri otrocih, zdravljenih z zdravilom STAYVEER, so enaki kot pri odraslih.
It is important that you have these regular blood tests as long as you are taking STAYVEER. 
Pomembno je, da redno opravljate preiskave krvi v času jemanja zdravila STAYVEER.
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. 
Nekateri bolniki, ki se ne odzovejo dobro pri odmerku 125 mg zdravila STAYVEER dvakrat na dan, bi lahko nekoliko izboljšali svojo fizično zmogljivost, če odmerek povišamo na 250 mg dvakrat na dan.
Concomitant use of STAYVEER with glibenclamide, fluconazole and rifampicin is not recommended. 
Sočasna uporaba zdravila STAYVEER z glibenklamidom, flukonazolom in rifampicinom se ne priporoča.
For PVC/PE/PVDC/aluminium-blisters: Do not store above 30 °C. 
Za pretisne omote PVC/PE/PVDC/aluminij: Shranjujte pri temperaturi do 30 °C.
Bosentan decreases both pulmonary and systemic vascular resistance resulting in increased cardiac output without increasing heart rate. 
Bosentan zmanjšuje tako pljučni kot sistemski žilni upor, kar povzroči povečan minutni volumen srca brez povišanja srčne frekvence.
If the decision to withdraw STAYVEER is taken, it should be done gradually while an alternative therapy is introduced. 
Če se odločite za prenehanje jemanja zdravila STAYVEER, je treba to izvesti postopoma, medtem ko sočasno uvajate drugo zdravljenje.
STAYVEER may harm unborn babies conceived before starting or during treatment. 
Zdravilo STAYVEER lahko škoduje nerojenemu otroku, spočetemu pred začetkom zdravljenja ali med njim.
The accumulation of bosentan in hepatocytes leading to cytolysis with potentially severe damage of the liver, or an immunological mechanism, are not excluded. 
Kopičenje bosentana v hepatocitih, kar lahko povzroči razpad celic s potencialno hudimi poškodbami jeter, ali imunološki mehanizem nista izključena.
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). 
Čeprav študije in vivo tega niso pokazale, lahko podobno povišanje plazemske koncentracije bosentana pričakujemo tudi z drugimi močnimi zaviralci CYP3A4 (denimo, itrakonazolom ali ritonavirjem).
In the AC-052-352 study, 92% of the 213 patients were classified at baseline as WHO functional class III and 8% as class IV. 
V študiji AC-052-352 so 92 % od 213 bolnikov izhodiščno opredelili v III. funkcijski razred po klasifikaciji SZO, 8 % pa v IV. razred.
Studies in animals have shown reproductive toxicity (teratogenicity, embryotoxicity; see section 5.3). 
Študije na živalih so pokazale vpliv na sposobnost razmnoževanja (teratogenost, embriotoksičnost, glejte poglavje 5.3).
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. 
Po 16 tednih je bila v skupini, ki je prejemala bosentan, povprečna saturacija s kisikom za 1,0 % (95-% IZ-0,7 %-2,8 %) večja kot v skupini, ki je prejemala placebo (n = 17), kar je dokazalo, da bosentan ni poslabšal hipoksemije.
The terminal elimination halflife (t1/2) is 5.4 hours. 
(t1/2) je 5,4 ur.
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. 
Zdravljenje z bosentanom je povzročilo pomembno povečanje srčnega indeksa, povezanega s pomembnim znižanjem pljučnega arterijskega tlaka, pljučnega žilnega upora in povprečnega tlaka v desnem preddvoru.
At adult age (Day 69 post partum), no effects of bosentan were detected at 1.3 (males) and 2.6 (females) times the therapeutic exposure in children with PAH. 
Pri odrasli starosti (69. dan po skotitvi) niso opazili učinkov bosentana pri 1,3-kratniku (samci) in 2,6-kratniku (samice) izpostavljenosti pri otrocih s PAH.
No effect of bosentan on time to healing of digital ulcers was observed in either study. 
Učinka bosentana na čas ozdravljenja razjed prstov niso opazili v nobeni študiji.
In BREATHE-3, the most frequent adverse reactions were flushing (21%), headache, and abnormal liver function test (each 16%). 
V študiji BREATHE-3 so bili najpogostejši neželeni učinki rdečica (21 %), glavobol in nenormalni testi delovanja jeter (po 16 %).
In neonates with persistent pulmonary hypertension of the newborn (PPHN), the benefit of bosentan has not been shown in the standard-of-care treatment. 
Pri novorojenčkih s trdovratno pljučno hipertenzijo novorojenčka (PPHN) korist bosentana pri zdravljenju s standardno terapijo ni bila dokazana.
For white high-density polyethylene bottles: 
Za bele plastenke iz polietilena visoke gostote:
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. 
V obdobju trženja so poročali o redkih primerih nerazložene jetrne ciroze po dolgotrajnem zdravljenju z zdravilom STAYVEER pri bolnikih s številnimi drugimi sočasnimi boleznimi in zdravljenji z zdravili.
Tacrolimus, sirolimus: Co-administration of tacrolimus or sirolimus and STAYVEER has not been studied in man but co-administration of tacrolimus or sirolimus and STAYVEER may result in increased plasma concentrations of bosentan in analogy to co-administration with cyclosporine A. Concomitant STAYVEER may reduce the plasma concentrations of tacrolimus and sirolimus. 
Takrolimus, sirolimus: Sočasne uporabe zdravila STAYVEER s takrolimusom in sirolimusom pri človeku sicer niso preučili, lahko pa sočasno dajanje takrolimusa ali sirolimusa z zdravilom STAYVEER povzroči povišane plazemske koncentracije bosentana po analogiji sočasnega dajanja ciklosporina A. Sočasno dajanje zdravila STAYVEER lahko zniža plazemske koncentracije takrolimusa in sirolimusa.
In vitro, bosentan inhibits the bile salt export pump in hepatocyte cultures. 
In vitro bosentan v hepatocitnih kulturah zavira črpalko žolčnih soli.
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. 
da si datum zadnje in naslednje preiskave (zdravnika prosite za datum) zapišete na Opozorilno kartico za bolnika, da si boste lažje zapomnili, kdaj imate naslednjo preiskavo.
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. 
Opazili so zvišanje vdihov na minuto in zmanjšanje zasičenosti s kisikom, pri čemer je bil najpogostejši neželeni učinek dispneja, ki je izginila s prekinitvijo uporabe bosentana.
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. 
Razlike med skupinama z odmerkom 125 mg dvakrat na dan in 250 mg dvakrat na dan niso bile statistično značilne, čeprav je bil prisoten trend izboljšanja fizične zmogljivosti v skupini, ki je jemala odmerek
After 16 weeks, the mean placebo-corrected increase in 6-minute walk distance was 53 metres (p = 0.0079), reflecting improvement in exercise capacity. 
Po 16 tednih je bilo povprečje s placebom korigiranega podaljšanja razdalje, prehojene v 6 minutah, 53 metrov (p = 0,0079), kar je kazalo izboljšanje zmogljivosti bolnikov za telesno vadbo.
STAYVEER therefore causes blood vessels to expand and belongs to the class of medicines called “endothelin receptor antagonists”. 
Zdravilo STAYVEER tako povzroči razširitev krvnih žil in sodi v skupino zdravil, imenovanih „antagonisti endotelinskih receptorjev”.
In patients with evidence of the presence of cholestasis, the exposure to the active metabolite may be increased. 
Pri bolnikih z znaki holestaze je lahko izpostavljenost aktivnemu presnovku večja.
Though the number of patients included was limited and with high variability, these data indicate a marked increase in the exposure to bosentan and its primary metabolite Ro 485033 in patients with moderate liver function impairment (Child-Pugh class B). 
Čeprav je bilo število vključenih bolnikov omejeno in so se med seboj močno razlikovali, nakazujejo ti podatki na veliko povešanje izpostavljenosti bosentanu in njegovemu primarnemu presnovku Ro 485033 pri bolnikih z zmerno okvaro delovanja jeter (razred B po klasifikaciji Child-Pugh).
During treatment with STAYVEER, your doctor will arrange for regular blood tests to check for changes in your liver function and haemoglobin level. 
Med zdravljenjem z zdravilom STAYVEER bo vaš zdravnik odredil redne krvne preiskave, s katerimi bo nadziral spremembe v delovanju vaših jeter in v ravni hemoglobina.
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. 
• Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
Inhibition of these isoenzymes may increase the plasma concentration of bosentan (see ketoconazole). 
Zaviranje teh izoencimov lahko poviša koncentracijo bosentana v plazmi (glejte ketokonazol).
• sirolimus or tacrolimus, which are medicines used after transplants, as these are not recommended to be used together with STAYVEER. 
• sirolimus ali takrolimus, zdravili, ki se uporabljata pri presaditvah, saj se njuna uporaba skupaj z zdravilom STAYVEER ne priporoča,
The same recommendations apply to reintroduction of STAYVEER after treatment interruption (see section 4.4). 
Enaka priporočila veljajo ob ponovni uvedbi zdravila STAYVEER po prekinitvi zdravljenja (glejte poglavje 4.4).
STAYVEER widens the pulmonary arteries, making it easier for the heart to pump blood through them. 
Zdravilo STAYVEER razširi pljučne arterije in olajša srcu črpanje krvi skozi te žile.
The aetiology of PAH, according to Dana Point classification, included idiopathic PAH (46%), heritable PAH (3%), associated PAH after corrective cardiac surgery (38%), and PAH related to congenital heart disease associated with systemic-topulmonary shunts, including Eisenmenger syndrome (13%). 
Etiologija PAH po klasifikaciji Dana Point je vključevala idiopatsko PAH (46 %), dedno PAH (3 %), PAH po korektivni srčni operaciji (38 %) in PAH, povezani s prirojeno boleznijo srca, povezano s sistemsko pljučnim šantom, vključno z
However, there was no evidence of bosentan affecting thyroid function (thyroxine, TSH) in humans. 
Ni pa bilo nobenih dokazov, da bi bosentan vplival na delovanje ščitnice (tiroksin, TSH) pri ljudeh.
• glibenclamide (a diabetes medicine), rifampicin (a tuberculosis medicine), fluconazole (a medicine against fungal infections), ketoconazole (a medicine used to treat Cushing's syndrome), or nevirapine (an HIV medicine), as these medicines are not recommended to be used together with STAYVEER. 
• glibenklamid (za zdravljenje sladkorne bolezni), rifampicin (za zdravljenje tuberkuloze), flukonazol (za zdravljenje glivičnih okužb), ketokonazol (za zdravljenje Cushingovega sindroma) ali nevirapin (za zdravljenje okužbe s HIV), saj se uporaba teh zdravil skupaj z zdravilom STAYVEER ne priporoča,
No drug-drug interaction data are available with the other sulfonylureas. 
Za druge sulfonilsečnine podatkov o medsebojnem delovanju zdravil ni.
STAYVEER 125 mg film-coated tablets EU/1/13/832/002 
STAYVEER 125 mg filmsko obložene tablete EU/1/13/832/002
The similarities of the pattern of malformations observed with other ET receptor antagonists and in ET knock-out mice indicate a class effect. 
Podobnosti v vzorcu malformacij, ki so jih opazili pri drugih antagonistih receptorjev ET in pri ET „knock-out“ miših,
However, some patients who show no response after 8 weeks of treatment with STAYVEER may respond favourably after an additional 4 to 8 weeks of treatment. 
STAYVEER ne pokažejo nobenega odziva, se lahko ugodno odzovejo po dodatnih 4 ali 8 tednih zdravljenja.
In study AC-052-391 (FUTURE 4) conducted in neonates, bosentan concentrations increased slowly and continuously over the first dosing interval, resulting in low exposure (AUC0-12 in whole blood: 
V študiji AC-052-391 (FUTURE 4), ki so jo izvedli pri novorojenčkih, so koncentracije bosentana v prvem intervalu odmerjanja počasi in stalno naraščale, kar je imelo za posledico nizko izpostavljenost (AUC0-12 v celi krvi: 164 ng·h/ml, n = 11).
Do not stop taking STAYVEER unless your doctor tells you to. 
Zdravilo STAYVEER jemljite, dokler vam vaš zdravnik ne reče, da ga nehajte jemati.