natgillin/translations-raw huggingface dataset:
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.
Ob vključitvi je bilo šest bolnikov starih od 3 mesecev do 1 leta, 15 otrok je bilo starih od 1 do manj kot 2 leti, 79 pa jih je bilo starih od 2 do 12 let.
This is most likely due to induction of CYP3A4 by bosentan.
To je najverjetneje posledica indukcije CYP3A4 z bosentanom.
In an animal model of pulmonary fibrosis, bosentan reduced collagen deposition in the lungs.
Na živalskih modelih pljučne fibroze je bosentan zmanjšal kopičenje kolagena v pljučih.
These will be done every month for the duration of treatment with STAYVEER.
Opravijo se vsak mesec v času zdravljenja z zdravilom STAYVEER.
• other medicines for the treatment of HIV infection, which may require special monitoring if used together with STAYVEER.
• druga zdravila za zdravljenje okužb s HIV, zaradi katerih je potrebno pri uporabi skupaj z zdravilom STAYVEER skrbno spremljanje,
At study start, less than half of the patients included (45.3% [29/64]) had bosentan treatment alone not combined with other PAH medication.
Ob začetku študije je bila več kot polovica vključenih bolnikov (45,3 % [29/64]) zdravljena samo z bosentanom, brez kombinacije z drugim zdravilom za PAH.
• fever (high temperature)
• zvišano telesno temperaturo (vročina)
• 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
• se zdravilo STAYVEER ne sme uvesti pri ženskah v rodni dobi, razen če uporabljajo zanesljivo kontracepcijo in je rezultat testa nosečnosti pred zdravljenjem negativen.
The mechanism of this interaction is most likely inhibition of transport protein-mediated uptake of bosentan into hepatocytes by cyclosporine.
Mehanizem tega medsebojnega delovanja je najverjetneje zaviranje transportne beljakovine za privzem bosentana v hepatocite, ki ga povzroči ciklosporin.
There was no evidence of any clinical benefit with 2 mg/kg three times daily as compared to 2 mg/kg twice daily dosing.
Ni dokazov o klinični koristi odmerjanja 2 mg/kg trikrat dnevno v primerjavi z odmerjanjem 2 mg/kg dvakrat dnevno.
Suddenly stopping your treatment with STAYVEER may lead to your symptoms getting worse.
Nenadna prekinitev zdravljenja z zdravilom STAYVEER lahko povzroči, da bodo vaši simptomi postali bolj izraziti.
If these results are abnormal, your doctor may decide to reduce your dose or stop treatment with STAYVEER and to perform further tests to investigate the cause.
Če bodo rezultati preiskav nenormalni, se bo vaš zdravnik lahko odločil za znižanje vašega odmerka ali prekinitev zdravljenja z zdravilom STAYVEER ter opravil dodatne preiskave, da bi odkril vzrok za nenormalne rezultate.
Tablets should be taken (morning and evening), swallowed with water.
Tableto morate vzeti zjutraj in zvečer, zaužijte jo z vodo.
What you need to know before you take STAYVEER Do not take STAYVEER:
Kaj morate vedeti, preden boste vzeli zdravilo STAYVEER Ne jemljite zdravila STAYVEER:
These effects are mediated by endothelin binding to ETA and ETB receptors located in the endothelium and vascular smooth muscle cells.
Te učinke posreduje endotelin, ki se veže na receptorje ETA in ETB, ki se nahajajo v endotelu in gladko mišičnih celicah obtočil.
The majority of patients were diagnosed as primary pulmonary hypertension (72%) and were in WHO functional class III (84%).
Pri večini bolnikov so ugotovili primarno pljučno hipertenzijo (72 %), bili pa so v III. funkcijskem razredu po merilih SZO (84 %).
Gender and concomitant use of intravenous epoprostenol had no significant effect on the pharmacokinetics of bosentan.
Spol in sočasna uporaba intravenskega epoprostenola nimata značilnega učinka na farmakokinetiko bosentana.
In a juvenile rat toxicity study, where rats were treated from Day 4 post partum up to adulthood, decreased absolute weights of testes and epididymides, and reduced number of sperm in epididymides were observed after weaning.
V študiji toksičnosti pri podganjih mladičih, kjer so podgane tretirali od 4. dne po skotitvi do odraslosti, so po ukinitvi dajanja opazili zmanjšano absolutno maso testisov in obmodkov ter zmanjšano število spermijev v obmodkih.
This was a double-blind, placebo-controlled, randomised study in pre-term or term neonates (gestational age 36-42 weeks) with PPHN.
To je bila dvojno slepa, s placebom nadzorovana, randomizirana študija pri nedonošenih in donošenih novorojenčkih (gestacijska starost 36-42 tednov) s PPHN.
As STAYVEER may render hormonal contraceptives ineffective, and taking into account the risk that pulmonary hypertension deteriorates with pregnancy as well as the teratogenic effects observed in animals:
Zdravilo STAYVEER lahko povzroči neučinkovitost hormonske kontracepcije, in ob upoštevanju, da se tveganje za pljučno hipertenzijo z nosečnostjo poslabša, ter teratogenih učinkov, opaženih pri živalih:
No specific studies have been conducted to assess the direct effect of STAYVEER on the ability to drive and use machines.
Specifičnih študij za ocenitev neposrednega učinka zdravila STAYVEER na sposobnost vožnje in upravljanja strojev niso izvedli.
Study performed in neonates with persistent pulmonary hypertension of the newborn (PPHN):
Študija opravljena pri novorojenčkih s trdovratno pljučno hipertenzijo novorojenčkov (PPHN):
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).
Bosentan tekmuje z vezavo ET-1 in drugih peptidov ET na receptorje ETA in ETB, z malo večjo afiniteto za receptorje ETA (Ki = 4,1-43 nanomolarna)) kot za receptorje ETB (Ki = 38
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