natgillin/translations-raw huggingface dataset:
Tadalafil: Bosentan (125 mg twice daily) reduced tadalafil (40 mg once per day) systemic exposure by 42% and Cmax by 27% following multiple dose co-administration. 
Tadalafil: bosentan (125 mg dva puta dnevno) smanjio je sistemsko izlaganje tadalafila (40 mg jednom na dan) za 42% te vrijednost Cmax za 27% nakon istodobne primjene višestruke doze.
Lopinavir+ritonavir (and other ritonavir-boosted protease inhibitors): Co-administration of bosentan 125 mg twice daily and lopinavir+ritonavir 400+100 mg twice daily for 9.5 days in healthy volunteers resulted in initial trough plasma concentrations of bosentan that were approximately 48-fold higher than those measured after bosentan administered alone. 
Lopinavir + ritonavir (i drugi ritonavirom pojačani inhibitori proteaze): istodobna primjena bosentana 125 mg dvaput dnevno i lopinavira 400 mg + ritonavira 100 mg dvaput dnevno kroz 9,5 dana kod zdravih dobrovoljaca rezultirala je početnim najnižim koncentracijama bosentana u plazmi koje su bile približno 48 puta više od onih izmjerenih nakon primjene bosentana samostalno.
White high-density polyethylene bottles with a silica gel desiccant containing 56 film-coated tablets. 
Bijele boce od polietilena visoke gustoće sa sredstvom za sušenje od silika gela sadrže 56 filmom obloženih tableta.
AC-052-355 was a multi-centre, randomised, double-blind, parallel-group study of bosentan versus placebo in 33 patients with severe PAH who were receiving concomitant epoprostenol therapy. 
AC-052-355 bila je multicentrična, randomizirana, dvostruko slijepa, s paralelnim grupama, studija bosentana u odnosu na placebo na 33 bolesnika s teškim PAH-om koji su istodobno dobivali epoprostenol.
((Back cover)) 
((Stražnja stranica))
Treatment with diuretics should be considered in patients with evidence of fluid retention before the start of treatment with STAYVEER. 
Liječenje diureticima treba uzeti u obzir u bolesnika u kojih je već prisutno zadržavanje tekućine prije početka liječenja STAYVEEROM.
In patients between 3 months and 1 year (n = 2) AUCτ was 5,914 ng·h/mL (CV: 85%), and in patients between 1 and 2 years (n = 7) AUCτ was 3,507 ng·h/mL (CV: 70%). 
U bolesnika starosti između 3 mjeseca i 1 godine (n = 2) AUCτ je bila 5914 ng•h/mL (CV: 85%) i u bolesnika starosti između 1 i 2 godine (n = 7), AUCτ je bila 3507 ng•h/mL (CV: 70%).
33 of these patients were provided with continued treatment with bosentan dispersible tablets at a dose of 4 mg/kg twice daily in the FUTURE 2 uncontrolled extension phase for a median overall treatment duration of 2.3 years (range: 0.2 to 5.0 years). 
Od tih bolesnika, njih 33 bilo je izloženo produljenom liječenju bosentanom u obliku tableta za oralnu suspenziju u dozi od 4 mg/kg dvaput na dan u fazi nekontrolianog produžetka studije FUTURE 2 i za njih je medijan sveukupnog trajanja liječenja iznosio 2,3 godine (raspon 0,2 do 5,0 godina).
Elevations to ≥ 8 × ULN were seen in 3.6% of the bosentan-treated patients and 0.4% of the placebo-treated patients. 
Povećanja za ≥ 8 × GGN viđena su u 3,6% bolesnika koji su dobivali bosentan i 0,4% bolesnika koji su dobivali placebo.
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). 
Moguć je spontani obrat povišenih vrijednosti aminotransferaza na normalne vrijednosti tijekom liječenja dozom održavanja ili nakon smanjenja doze, a ponekad je potreban privremeni ili potpuni prekid liječenja (vidjeti dio 4.4).
At study entry, patients were treated with PAH medications (most frequently phosphodiesterase type-5 inhibitor [sildenafil] alone [35.9%], bosentan alone [10.9%], and a combination of bosentan, iloprost, and sildenafil [10.9%]) and continued their PAH treatment during the study. 
5 [sildenafil] u monoterapiji [35,9%], bosentanom u monoterapiji [10,9%] i kombinacijom bosentana, iloprosta i sildenafila [10,9%]) i nastavili su svoje liječenje za PAH tijekom studije.
In rats, oral administration of bosentan for 2 years produced a small, significant increase in the combined incidence of thyroid follicular cell adenomas and carcinomas in males, but not in females, at plasma concentrations about 9 to 14 times the plasma concentrations achieved at the therapeutic dose in humans. 
U štakora je oralna primjena bosentana tijekom 2 godine dovela do malog, ali značajnog povećanja kombinirane učestalosti adenoma i karcinoma folikularnih stanica štitnjače u mužjaka, ali ne i ženki, kod koncentracija u plazmi koje su 9 do 14 puta veće od onih koje se postižu kod terapijskih doza u ljudi.
Hypotension1, 4 
Hipotenzija1,4
It was primarily designed as a pharmacokinetic study (see section 5.2). 
Bila je zamišljena prvenstveno kao farmakokinetička studija (vidjeti dio 5.2).
This study was primarily designed as a pharmacokinetic study (see section 5.2). 
Ta studija zamišljena je prvenstveno kao farmakokinetička studija (vidjeti dio 5.2).
The combination of bosentan and epoprostenol has been investigated in two studies: AC-052-355 (BREATHE-2) and AC-052-356 (BREATHE-3). 
Kombinacija s epoprostenolom Kombinacija bosentana i epoprostenola ispitana je u sklopu dvije studije: AC-052-355 (BREATHE-2)
Bosentan is an inducer of CYP2C9 and CYP3A4 and possibly also of CYP2C19 and the P-glycoprotein. 
Bosentan inducira CYP2C9 i CYP3A4, a vjerojatno i CYP2C19, kao i p-glikoprotein.
Cases of pulmonary oedema have been reported with vasodilators (mainly prostacyclins) when used in patients with pulmonary veno-occlusive disease. 
Slučajevi plućnog edema zabilježeni su kod primjene vazodilatatora (uglavnom prostaciklina) u bolesnika s okluzivnom bolesti plućnih vena.
In the FUTURE-4 study, 6 out of 13 bosentan-treated neonates with PPHN experienced a decrease in haemoglobin from within the reference range at baseline to below the lower limit of normal during the treatment. 
U studiji FUTURE-4, u 6 od 13 novorođenčadi s PPHN-om liječene bosentanom došlo je do smanjenja razine hemoglobina s normalne razine na početku liječenja na razinu ispod donje razine referentnih vrijednosti tijekom liječenja.
Based on physicochemical properties and the high degree of protein binding, bosentan is not expected to be removed from the circulation by dialysis to any significant extent (see section 4.2). 
Na osnovi fizičko-kemijskih svojstava i visokog stupnja vezanja za proteine, za bosentan se ne očekuje da se može ukloniti iz krvi dijalizom u značajnijoj mjeri
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. 
Učestalost promjena doze varfarina tijekom studija uslijed promjena INR-a ili nuspojava bila je slična među bolesnicima koji su dobivali bosentan, odnosno placebo.
STAYVEER reduces the number of new finger and toe ulcers that appear. 
STAYVEER smanjuje pojavljivanje novih ulceracija na prstima ruku i nogu.
In vitro data demonstrated that bosentan had no relevant inhibitory effect on the CYP isoenzymes tested (CYP1A2, 2A6, 2B6, 2C8, 2C9, 2D6, 2E1, 3A4). 
izoenzime (CYP1A2, 2A6, 2B6, 2C8, 2C9, 2D6, 2E1, 3A4).
Breast-feeding is not recommended during treatment with STAYVEER. 
Dojenje se ne preporučuje tijekom liječenja
The dosage of these products may need to be adjusted after initiation, dose change or discontinuation of concomitant STAYVEER treatment. 
Doziranje tih lijekova treba prilagoditi nakon početka istodobnog liječenja STAYVEEROM, kod promjene doze ili kod prekida istodobnog liječenja STAYVEEROM.
What you need to know before you take STAYVEER Do not take STAYVEER: 
Što morate znati prije nego počnete uzimati STAYVEER
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. 
t-test), odnosno 44 metra (p = 0,0002, Mann-Whitney U-test) u primarnom ishodu svake studije.
Take this card to your doctor or your gynaecologist at your next visit and he/she will be able to advise you on whether you need to use additional or alternative contraceptive methods. 
Ponesite ovu karticu Vašem liječniku ili ginekologu prilikom sljedeće posjete kako bi Vaš liječnik ili ginekolog mogli odrediti da li Vam je potrebna dodatna ili drugačija pouzdana metoda kontracepcije.
The table below illustrates the pre-specified protocol analyses. 
Donja tablica prikazuje provedene analize.
Limited data in patients show that the exposure to bosentan in adult PAH patients is approximately 2-fold greater than in healthy adult subjects. 
Ograničeni podaci za odrasle bolesnike s PAH-om pokazuju približno 2 puta veću izloženost bosentanu kod bolesnika nego kod zdravih osoba.
How to take STAYVEER 
Kako uzimati STAYVEER
Intensified monitoring is recommended during the discontinuation period. 
Preporučuje se intenzivno praćenje bolesnika tijekom perioda prekida uzimanja lijeka.
In the post-marketing period there have been rare reports of pulmonary oedema in patients treated with STAYVEER who had a suspected diagnosis of pulmonary veno-occlusive disease. 
postmarketinškom razdoblju rijetko su zabilježeni slučajevi plućnog edema u bolesnika koji su dobivali STAYVEER i u kojih je postojala sumnja na okluzivnu bolest plućnih vena.
In this open-label randomised study with the bosentan 32 mg dispersible tablet formulation, 64 children with stable PAH from 3 months to 11 years of age were randomised to 24 weeks' bosentan treatment 2 mg/kg twice daily (n = 33) or 2 mg/kg three times daily (n = 31). 
U ovoj otvorenoj randomiziranoj studiji s 32 mg bosentana u obliku tablete za oralnu suspenziju, 64 djece sa stabilnim PAH-om u dobi od 3 mjeseca do 11 godina randomizirano je u skupine liječenja bosentanom u dozi od 2 mg/kg dvaput na dan (n = 33) ili u dozi od 2 mg/kg triput na dan (n = 31) tijekom 24 tjedna.
- The other ingredients in the tablet core are maize starch, pregelatinised starch, sodium starch glycolate (Type A), povidone, glycerol dibehenate and magnesium stearate. 
- Drugi sastojci u jezgri tablete su kukuruzni škrob, prethodno gelirani škrob, natrijev škroboglikolat vrste A, povidon, gliceroldibehenat i magnezijev stearat.
Keep this medicine out of the sight and reach of children. 
Kako čuvati STAYVEER Lijek čuvajte izvan pogleda i dohvata djece.
You need to use a barrier form of birth control - like a condom, diaphragm or vaginal sponge - in addition to any of these kinds of hormonal birth control. 
Stoga morate također primjenjivati metodu fizičke barijere - npr. kondom, dijafragma ili kontracepcijska spužva - uz bilo koje od navedenih vrsta hormonalne kontracepcije.
• nausea (urge to vomit) 
• mučninu (nagon na povraćanje)
However, 1,611 patients (804 bosentan- and 807 placebo-treated patients) with severe chronic heart failure (CHF) were treated for a mean duration of 1.5 years in a placebo controlled study (study AC-052-301/302 [ENABLE 1 & 2]). 
Međutim, na 1611 bolesnika (804 je dobivalo bosentan, a 807 placebo) s teškim kroničnim zatajenjem srca provedena je placebom kontrolirana studija u prosječnom trajanju od 1,5 godine (studija AC-052
• Thrombocytopenia (low number of blood platelets) 
• Trombocitopenija (smanjen broj krvnih pločica)
The median exposure to study treatment was 4.5 (range: 0.5-10.0) days in the bosentan group and 4.0 (range: 2.5-6.5) days in the placebo group. 
Medijan izloženosti ispitivanom liječenju bio je 4,5 (raspon 0,5-10,0) dana u skupini koja je primala bosentan i 4,0 (raspon 2,5-6,5) dana u skupini koja je primala placebo.
3 Headache was reported in 11.5% of patients on bosentan and 9.8% of patients on placebo. 
3 Glavobolja je prijavljena u 11,5% bolesnika koji su dobivali bosentan i 9,8% bolesnika koji su dobivali placebo.
Aminotransferase levels must then be checked within 3 days after re-introduction, then again after a further 2 weeks, and thereafter according to the recommendations above. 
Ponovno liječenje treba biti u skladu sa smjernicama danim u dijelu 4.2. Vrijednosti aminotransferaza treba provjeriti do 3 dana nakon ponovnog početka liječenja, nakon 2 tjedna te potom u skladu s gore navedenim preporukama.
It cannot be excluded that this may affect your ability to father a child. Talk to your doctor if you have any questions or concerns about this. 
Ne može se isključiti mogućnost da to utječe na Vašu sposobnost da imate dijete.
Monitoring of cholesterol levels and subsequent dosage adjustment should be considered. 
Treba pratiti razinu kolesterola i u skladu s njom po potrebi prilagoditi dozu simvastatina.
The steady-state AUC of bosentan was 9% higher and the AUC of the active metabolite, Ro 48-5033, was 33% higher in patients with mild hepatic impairment than in healthy volunteers. 
njegovog aktivnog metabolita, Ro 48-5033, bila je 33% veća u bolesnika s blagim smanjenjem jetrene funkcije nego u zdravih dobrovoljaca.
Of the 22 patients stable at week 8, 6 improved at week 12/16 and 4 deteriorated compared with baseline. 
Od 22 bolesnika čije je stanje bilo stabilno nakon 8 tjedana u njih 6 došlo je do poboljšanja nakon 12/16 tjedana, a u 4 je došlo do pogoršanja u odnosu na početnu vrijednost.
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) 
Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2)
It is not known whether bosentan is excreted into human breast milk. 
Nije poznato izlučuje li se bosentan u majčino mlijeko.
Treatment with bosentan resulted in fewer new digital ulcers for the duration of therapy, compared with placebo. 
Kod liječenja bosentanom bilo je manje novih ulceracija prstiju nego kod placeba.
56 film-coated tablets 112 film-coated tablets 
56 filmom obloženih tableta 112 filmom obloženih tableta
Patients had primary pulmonary hypertension (10 patients) or PAH related to congenital heart diseases (9 patients) and were in WHO functional class II (n = 15, 79%) or class III (n = 4, 21%) at baseline. 
Obuhvaćeno je 10 bolesnika s primarnom plućnom hipertenzijom i 9 bolesnika s PAH-om povezanim s kongenitalnom srčanom bolesti koji su bili WHO funkcionalnog stupnja II (n = 15, 79%) ili stupnja III (n = 4, 21%) na početku studije.
These increases may be partly due to competitive inhibition of the elimination of bile salts from hepatocytes but other mechanisms, which have not been clearly established, are probably also involved in the occurrence of liver dysfunction. 
Povišenje jetrenih enzima dijelom može biti uzrokovano kompetitivnom inhibicijom eliminacije žučnih soli iz hepatocita, kao i drugim, još neutvrđenim mehanizmima poremećaja funkcije jetre.
Very common (may affect more than one in 10 people): 
Vrlo česte (mogu se pojaviti u više od 1 na 10 osoba):
In the pooled analysis of 100 PAH children from uncontrolled paediatric studies FUTURE 1/2 and FUTURE 3/Extension, a decrease in haemoglobin concentration from baseline to below 10 g/dL was reported in 10.0% of patients. 
U analizi objedinjenih podataka 100 djece s PAH-om iz nekontroliranih pedijatrijskih studija FUTURE 1/2 i FUTURE 3/produžetak, zabilježeno je smanjenje koncentracije hemoglobina od početne vrijednosti na ispod 10 g/dl u 10,0% bolesnika.
Of the 7 patients who deteriorated at week 8, 3 improved at week 12/16 and 4 deteriorated compared with baseline. 
Od 7 bolesnika kod kojih je došlo do pogoršanja nakon 8 tjedana, u njih 3 došlo je do poboljšanja nakon 12/16 tjedana, a u 4 je došlo do pogoršanja.
The benefit/risk balance of bosentan has not been established in patients with WHO class I functional status of PAH. 
Omjer koristi i rizika kod primjene bosentana nije ustanovljen u bolesnika s PAH-om WHO funkcionalnog stupnja I.
Palpitations1, 4 
Palpitacije1,4
Sildenafil: Co-administration of bosentan 125 mg twice daily (steady state) with sildenafil 80 mg three times a day (at steady state) concomitantly administered during 6 days in healthy volunteers resulted in a 63% decrease in the sildenafil AUC and a 50% increase in the bosentan AUC. 
Sildenafil: istodobna primjena bosentana 125 mg dvaput dnevno (u stanju dinamičke ravnoteže) sa sildenafilom 80 mg tri puta dnevno (u stanju dinamičke ravnoteže) tijekom 6 dana u zdravih dobrovoljaca dovela je do smanjenja AUC-a kod sildenafila za 63% i povećanja AUC-a kod bosentana za 50%.
Treatment with bosentan was associated with a reduction in the rate of clinical worsening, defined as a composite of symptomatic progression, hospitalisation for PAH and death, compared with placebo (proportional risk reduction 77%, 95% confidence interval [CI] 20-94%, p = 0.0114). 
koju zajednički određuju napredovanje simptoma, hospitalizacija zbog PAH-a i smrt (smanjenje rizika za 77%, 95% interval pouzdanosti [CI] 20-94%, p = 0,0114).
No specific study has been performed in patients with pulmonary hypertension and concomitant left ventricular dysfunction. 
Nije provedena posebna studija u bolesnika s PAH-om i istodobnim zatajenjem lijevog ventrikula.
• Cirrhosis (scarring) of the liver, liver failure (serious disturbance of liver function) 
• Ciroza (stvaranje ožiljaka) jetre, zatajenje jetre (teški poremećaj funkcije jetre)
Data on other CYP3A4 inducers, e.g., carbamazepine, phenobarbital, phenytoin and St. John's wort are lacking, but their concomitant administration is expected to lead to reduced systemic exposure to bosentan. 
Premda nema podataka o drugim induktorima CYP3A4, poput karbamazepina, fenobarbitala, fenitoina i gospine trave, očekuje se smanjeno sistemsko izlaganje bosentanu kod njegove istodobne primjene s navedenim lijekovima.
Twenty-six patients continued to receive bosentan in the 24-week open-label extension phase (AC-052-409) of the BREATHE-5 study (mean duration of treatment = 24.4 ± 2.0 weeks) and, in general, efficacy was maintained. 
(AC-052-409) ispitivanja BREATHE-5 (srednje trajanje liječenja = 24,4 ± 2,0 tjedna), i općenito je djelotvornost bila održana.
In healthy subjects, bosentan displays dose- and time-dependent pharmacokinetics. 
U zdravih osoba farmakokinetika bosentana ovisna je o dozi i vremenu.
Change from BL; mean (SD) 
srednja vrijednost (SD) Promjena u odnosu na BL; srednja vrijednost (SD)
((Front cover)) 
((Prednja stranica))
In study AC-052-401, during 16 weeks of double-blind therapy, patients in the bosentan group developed a mean of 1.4 new digital ulcers vs 2.7 new digital ulcers in the placebo group (p = 0.0042). 
U studiji AC-052-401 tijekom 16 tjedana dvostruko slijepe terapije u bolesnika koji su dobivali bosentan pojavilo se u prosjeku 1,4 novih ulceracija prstiju u odnosu na 2,7 novih ulceracija prstiju u skupini koja je dobivala placebo (p = 0,0042).
• One patient in the bosentan group had treatment failure (need for ECMO as per protocol definition), which was declared based on increasing Oxygenation Index values within 8 h after the first study drug dose. 
(potrebe za ECMO prema definiciji protokola) koji je utvrđen na temelju rastućih vrijednosti oksigenacijskog indeksa unutar 8 sati od davanja prve doze ispitivanog lijeka.
The co-primary endpoints were percentage change from baseline in pulmonary vascular resistance (PVR) and change from baseline in 6-minute walk distance to Month 6 versus placebo. 
Ko-primarne mjere ishoda bile su postotak promjene plućnog krvožilnog otpora (PVR) i promjena u udaljenosti prijeđenoj šestominutnim hodanjem nakon šest mjeseci u odnosu na stanje prije liječenja, u usporedbi s placebom.
Inside your pack of STAYVEER tablets you will find a Patient Alert Card. You should complete this card and take it to your doctor at your next visit so that your doctor or gynaecologist can assess whether you need additional or alternative reliable contraceptive methods. 
Trebate je popuniti i uzeti je sa sobom kada idući put idete liječniku kako bi Vaš liječnik ili ginekolog ocijenio trebate li dodatnu ili drugu pouzdanu kontracepcijsku metodu.
After 4 weeks of bosentan 62.5 mg twice daily, the maintenance dose studied in both these studies was 125 mg twice daily. 
Nakon 4 tjedna primanja bosentana 62,5 mg dvaput dnevno, doza održavanja bila je 125 mg dvaput dnevno u obje studije.
In patients between 3 months and 2 years the daily exposure was 7,879 ng·h/mL; AUCτ was 3,939 ng·h/mL (CV: 72%). 
U bolesnika starosti između 3 mjeseca i 2 godine dnevna izloženost bila je 7879 ng•h/mL; AUCτ je bila 3939 ng•h/mL (CV: 72%).
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. 
STAYVEEROM mogu pozitivno reagirati nakon dodatnih 4 do 8 tjedana liječenja.
Rifampicin: Co-administration in 9 healthy subjects for 7 days of bosentan 125 mg twice daily with rifampicin, a potent inducer of CYP2C9 and CYP3A4, decreased the plasma concentrations of bosentan by 58%, and this decrease could achieve almost 90% in an individual case. 
Rifampicin: istodobna primjena u 9 zdravih osoba kroz 7 dana bosentana 125 mg dvaput dnevno s rifampicinom, jakim induktorom CYP2C9 i CYP3A4, smanjila je koncentracije bosentana u plazmi za 58%, a u pojedinim slučajevima i za gotovo 90%.
Treatment with bosentan has been associated with dose-dependent elevations in liver aminotransferases and decreases in haemoglobin concentration (see section 4.4). 
Liječenje bosentanom povezano je s povišenjem vrijednosti jetrenih aminotransferaza ovisnim o dozi i smanjenjem koncentracije hemoglobina (vidjeti dio 4.4).
In the patients above 2 years (n = 22) the daily exposure was 8,820 ng·h/mL; AUCτ was 4,410 ng·h/mL (CV: 58%). 
U bolesnika starijih od 2 godine (n = 22) dnevna izloženost bila je 8820 ng•h/mL; AUCτ je bila 4410 ng•h/mL (CV: 58%).
Bosentan is metabolised by CYP2C9 and CYP3A4. 
Bosentan metaboliziraju CYP2C9 i CYP3A4.
Two randomised, double-blind, multi-centre, placebo-controlled studies have been conducted in 122 (study AC-052-401 [RAPIDS-1]) and 190 (study AC-052-331 [RAPIDS-2]) adult patients with systemic sclerosis and digital ulcer disease (either ongoing digital ulcers or a history of digital ulcers within the previous year). 
Sistemska skleroza s bolešću ulceracije prstiju Dvije randomizirane, dvostruko slijepe, multicentrične, placebom kontrolirane studije provedene su na 122 (studija AC-052-401 [RAPIDS-1]) i 190 (studija AC-052-331 [RAPIDS-2]) odrasla bolesnika sa sistemskom sklerozom i bolešću ulceracija prstiju (trenutačno prisutne ulceracije ili postojanje ulceracija u anamnezi unatrag godine dana).
If any of these apply to you, tell your doctor. 
Ako se bilo što od navedenog odnosi na Vas, obratite se svom liječniku.
Efficacy in adult patients with pulmonary arterial hypertension Two randomised, double-blind, multi-centre, placebo-controlled studies have been conducted in 32 (study AC-052-351) and 213 (study AC-052-352 [BREATHE-1]) adult patients with WHO functional class III-IV PAH (primary pulmonary hypertension or pulmonary hypertension secondary mainly to scleroderma). 
Djelotvornost kod odraslih bolesnika s plućnom arterijskom hipertenzijom Dvije randomizirane, dvostruko slijepe, multicentrične, placebom kontrolirane studije provedene su na 32 (studija AC-052-351) i 213 (studija AC-052-352 [BREATHE-1]) odrasla bolesnika s PAH-om
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. 
postpartalnog dana sve do odrasle dobi, nakon odvikavanja je zabilježena smanjena apsolutna težina testisa i epididimisa i smanjen broj spermija u epididimisima.
STAYVEER” 
STAYVEEROM.
Your name: __________________________________________________ Prescribing doctor: ________________________________________ If you have questions about STAYVEER ask your doctor. 
Ako imate pitanja o lijeku STAYVEER, pitajte svog liječnika.
The safety profile of the combination was not different from the one expected with each component and the combination therapy was well tolerated in children and adults. 
Sigurnost primjene kombinacije lijekova nije se razlikovala od sigurnosti primjene svakog lijeka zasebno.
CARTON WITH 56 TABLETS 
PAKIRANJE S 56 TABLETA
Blood tests for liver function 
Krvne pretrage za funkciju jetre