natgillin/translations-raw huggingface dataset:
Breast-feeding is not recommended during treatment with Tracleer. 
Dojenje se ne preporučuje tijekom liječenja
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON WITH 56 TABLETS 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PAKIRANJE S 56 TABLETA
Patients in need of the combination should be closely monitored for adverse events related to Tracleer and for tacrolimus and sirolimus blood concentrations. 
Bolesnike kojima je potrebna kombinacija tih lijekova treba pažljivo nadzirati s obzirom na pojavu nuspojava vezanih za Tracleer te s obzirom na koncentracije takrolimusa ili sirolimusa u plazmi.
Tracleer 62.5 mg film-coated tablets PVC/PE/PVDC/aluminium-blisters containing 14 film-coated tablets. 
Tracleer 62,5 mg filmom obložene tablete PVC/PE/PVDC/aluminij blisteri koji sadrže 14 filmom obloženih tableta.
Cartons contain 14, 56 or 
Kutije sadrže 14, 56 ili 112
A Patient Alert Card providing important safety information that patients need to be aware of before and during treatment with Tracleer is included in the pack. 
U pakiranje lijeka uključena je Kartica s upozorenjima za bolesnika koja sadrži važne sigurnosne informacije kojih bolesnici moraju biti svjesni prije i tijekom liječenja lijekom Tracleer.
If the aminotransferase levels return to pre-treatment values reintroducing Tracleer according to the conditions described below should be considered. 
Ako se vrijednosti aminotransferaza vrate na vrijednosti prije liječenja, treba razmotriti ponovno liječenje Tracleerom u skladu s dolje navedenim uvjetima.
However, some patients who show no response after 8 weeks of treatment with Tracleer may respond favourably after an additional 4 to 8 weeks of treatment. 
Tracleerom mogu pozitivno reagirati nakon dodatnih 4 do 8 tjedana liječenja.
Monthly pregnancy tests are recommended while you are taking Tracleer and are of childbearing age. 
preporučuju se mjesečni testovi na trudnoću tijekom uzimanja Tracleera.
Tracleer treatment should be initiated at a dose of 62.5 mg twice daily for 4 weeks and then increased to the maintenance dose of 125 mg twice daily. 
Liječenje Tracleerom treba započeti dozom od 62,5 mg dvaput dnevno u trajanju od 4 tjedna i potom povećati na dozu održavanja od 125 mg dvaput dnevno.
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. 
409) ispitivanja BREATHE-5 (srednje trajanje liječenja = 24,4 ± 2,0 tjedna) i općenito je djelotvornost bila održana.
Consequently, plasma concentrations of substances metabolised by these isoenzymes will be decreased when Tracleer is co-administered. 
Stoga su koncentracije tvari koje metaboliziraju ti izoenzimi kod istodobne primjene Tracleera smanjene u plazmi.
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%). 
mjeseca i 2 godine dnevna izloženost bila je 7879 ng•h/mL; AUCτ je bila 3939 ng•h/mL (CV: 72%).
In adult patients, Tracleer treatment should be initiated at a dose of 62.5 mg twice daily for 4 weeks and then increased to the maintenance dose of 125 mg twice daily. 
Kod odraslih bolesnika, liječenje Tracleerom treba započeti dozom od 62,5 mg dvaput dnevno u trajanju od 4 tjedna i potom povećati na dozu održavanja od 125 mg dvaput dnevno.
Dispersible tablet: 
Tableta za oralnu suspenziju:
A little more water should be added to the spoon and swallowed by the patient, to make sure all of the medicine has been administered. 
Bolesnik treba dodati još malo vode na žlicu i progutati je kako bi bio siguran da je uzeo sav lijek.
Tracleer 125 mg film-coated tablets PVC/PE/PVDC/aluminium-blisters containing 14 film-coated tablets. 
Tracleer 125 mg filmom obložene tablete PVC/PE/PVDC/aluminij blisteri koji sadrže 14 filmom obloženih tableta.
Hold the tablet between the thumb and the index finger on either side of the score line, with the score line facing upwards. 
Držite tabletu palcem i kažiprstom jedne ruke s jedne strane linije i palcem i kažiprstom druge ruke s druge strane linije okrenute prema gore.
The median bosentan and placebo treatment duration was, respectively, 4.5 days (range 0.5-10.0 days) and 4.0 days (range 2.5-6.5 days). 
4,5 dana (raspon 0,5-10,0 dana), a placebom 4,0 dana (raspon 2,5-6,5 dana).
• if you are taking cyclosporine A (a medicine used after a transplant or to treat psoriasis) If any of these apply to you, tell your doctor. 
• ako uzimate ciklosporin A (lijek koji se koristi nakon transplantacije ili za liječenje psorijaze)
Keep this medicine out of the sight and reach of children. 
Kako čuvati Tracleer Lijek čuvajte izvan pogleda i dohvata djece.
• Cirrhosis (scarring) of the liver, liver failure (serious disturbance of liver function) Blurred vision have also been reported at an unknown frequency (frequency cannot be estimated from the available data). 
Također je zabilježen i zamagljen vid s nepoznatom učestalošću (ne može se procijeniti iz dostupnih podataka).
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
Patients were treated with bosentan 62.5 mg twice daily for 4 weeks followed by 125 mg twice daily for a further 12 weeks. 
Bolesnici su dobivali bosentan 62,5 mg dvaput dnevno tijekom 4 tjedna, a potom 125 mg dvaput dnevno tijekom daljnjih 12
Tracleer 32 mg dispersible tablets are pale yellow to off-white, clover-shape dispersible tablets, quadrisected on one side and debossed with “32” on the other side. 
Tableta za oralnu suspenziju Tracleer 32 mg je blijedo žute do gotovo bijele boje, oblika djeteline, s razdjelnim urezima na četvrtine s jedne strane i s oznakom „32“ s druge strane.
If necessary the dispersible tablet can be divided along the break-marks into four equal parts. 
Ako je potrebno, tableta za oralnu suspenziju može se, pomoću oznaka, razdijeliti na četiri jednaka dijela.
Skin and subcutaneous disorders Common 
Poremećaji kože i potkožnog tkiva Često
Peel-push blisters containing 14 dispersible tablets; cartons contain 56 dispersible tablets. 
Blisteri sadrže 14 tableta za oralnu suspenziju; pakiranja sadrže 56 tableta za oralnu suspenziju.
Bosentan is eliminated by biliary excretion following metabolism in the liver by the cytochrome P450 isoenzymes, CYP2C9 and CYP3A4. 
Bosentan se eliminira izlučivanjem putem žuči, nakog metaboliziranja putem citokrom P450 izoenzima CYP2C9 i CYP3A4 u jetri.
The dispersible tablet can be divided into four equal parts. 
Tableta za oralnu suspenziju može se radijeliti na četiri jednaka dijela.
A careful benefit/risk assessment should be made, taking into consideration that the liver toxicity is dose dependent (see sections 4.4 and 5.1). 
uzimajući u obzir da je toksično djelovanje na jetru ovisno o dozi (vidjeti dijelove 4.4 i 5.1).
• dark-coloured urine 
• tamno obojenu mokraću
Baseline (BL); mean (SD) Change from BL; mean (SD) Treatment effects 95% CL 
srednja vrijednost (SD) Promjena u odnosu na BL; srednja vrijednost (SD)
Tacrolimus, sirolimus: Co-administration of tacrolimus or sirolimus and Tracleer has not been studied in man but co-administration of tacrolimus or sirolimus and Tracleer may result in increased plasma concentrations of bosentan in analogy to co-administration with cyclosporine A. Concomitant Tracleer may reduce the plasma concentrations of tacrolimus and sirolimus. 
Takrolimus, sirolimus: istodobna primjena takrolimusa ili sirolimusa s Tracleerom nije ispitana u ljudi, ali istodobna primjena takrolimusa ili sirolimusa s Tracleerom kao i kod ciklosporina
A 2-year carcinogenicity study in mice showed an increased combined incidence of hepatocellular adenomas and carcinomas in males, but not in females, at plasma concentrations about 2 to 4 times the plasma concentrations achieved at the therapeutic dose in humans. 
Dvogodišnja studija kancerogenosti na miševima pokazala je povećanu kombiniranu učestalost hepatocelularnih adenoma i karcinoma u mužjaka, ali ne i ženki, kod koncentracija u plazmi koje su 2
- The other ingredients are cellulose microcrystalline, calcium hydrogen phosphate anhydrous, croscarmellose sodium, silica colloidal anhydrous, tartaric acid, tutti frutti flavour, aspartame (E951, please read further information at the end of section 2), acesulfame potassium, magnesium stearate. 
6.1 Popis pomoćnih tvari celuloza, mikrokristalična kalcijev hidrogenfosfat, bezvodni karmelozanatrij, umrežena silicijev dioksid, koloidni, bezvodni tartaratna kiselina tutti frutti okus aspartam (E951) acesulfamkalij magnezijev stearat
Cartons contain 56 film-coated tablets. 
Kutije sadrže 56 filmom obloženih tableta.
Treatment with Tracleer should only be started and monitored by a doctor who has experience in the treatment of PAH or systemic sclerosis. 
Liječenje treba započeti i nadzirati jedino liječnik s iskustvom u liječenju plućne arterijske hipertenzije ili sistemske skleroze.
For PVC/PE/PVDC/aluminium-blisters: Do not store above 30 °C. 
Za PVC/PE/PVDC/aluminij blistere:
Tracleer 62.5 mg film-coated tablets Each film-coated tablet contains 62.5 mg bosentan (as monohydrate). 
Tracleer 62,5 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 62,5 mg bosentana (u obliku bosentan hidrata).
In a randomised, double-blind, multi-centre, placebo-controlled study (AC-052-364 [EARLY]), 185 PAH patients in WHO functional class II (mean baseline 6-minute walk distance of 435 metres) received bosentan 62.5 mg twice daily for 4 weeks followed by 125 mg twice daily (n = 93), or placebo (n = 92) for 6 months. 
[EARLY]) 185 bolesnika s PAH-om WHO funkcionalnog stupnja II (srednja početna vrijednost udaljenosti prijeđene šestominutnim hodanjem od 435 metara) dobivali su bosentan 62,5 mg dvaput dnevno tijekom 4 tjedna, a potom 125 mg dvaput dnevno (n = 93) ili placebo (n = 92) tijekom 6
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). 
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
Tracleer 125 mg film-coated tablets Each film-coated tablet contains 125 mg bosentan (as monohydrate). 
Tracleer 125 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 125 mg bosentana (u obliku bosentan hidrata).
Package leaflet: Information for the user Tracleer 62.5 mg film-coated tablets 
Uputa o lijeku: Informacije za korisnika Tracleer 62,5 mg filmom obložene tablete bosentan
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. 
92% od 213 bolesnika imalo je prije liječenja WHO funkcionalni stupanj III, a 8% stupanj IV.
- Tracleer 62.5 mg film-coated tablets: The active substance is bosentan as monohydrate. 
- Tracleer 62,5 mg filmom obložene tablete: Djelatna tvar je bosentan u obliku bosentan hidrata.
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
Concomitant use of Tracleer and cyclosporine A is contraindicated (see sections 4.3 and 4.5). 
Istodobna primjena s drugim lijekovima Kontraindicirana je istodobna primjena Tracleera s ciklosporinom A (vidjeti dio 4.3 i 4.5).
film-coated tablets (Tracleer 125 mg film-coated tablets). 
filmom obloženih tableta (Tracleer 125 mg filmom obložene tablete).
Package leaflet: Information for the user Tracleer 125 mg film-coated tablets 
Uputa o lijeku: Informacije za korisnika Tracleer 125 mg filmom obložene tablete bosentan
Tracleer 125 mg tablets bosentan 
Tracleer 125 mg tablete bosentan
Do not swallow the desiccant 
Nemojte progutati sredstvo za sušenje
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. 
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.
Laboratory abnormalities 
Abnormalne vrijednosti laboratorijskih nalaza
Simvastatin: Co-administration of bosentan 125 mg twice daily for 5 days decreased the plasma concentrations of simvastatin (a CYP3A4 substrate) and its active β-hydroxy acid metabolite by 34% and 46%, respectively. 
Simvastatin: istodobna primjena bosentana 125 mg dvaput dnevno tijekom 5 dana dovela je do smanjenja koncentracija simvastatina u plazmi (susptrat CYP3A4) te njegovog aktivnog β hidroksikiselinskog metabolita za 34%, odnosno 46%.
Tracleer 62.5 mg tablets bosentan 
Tracleer 62,5 mg tablete bosentan
Tracleer 62.5 mg film-coated tablets Tracleer 125 mg film-coated tablets 
Tracleer 62,5 mg filmom obložene tablete Tracleer 125 mg filmom obložene tablete
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). 
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)
To remove the dispersible tablet: 
Kako biste izvadili tabletu za oralnu suspenziju:
Birth control based on hormones - such as oral contraceptives or birth control pills, hormone injections, implants, or birth control skin patches don't reliably prevent pregnancy in women who are taking Tracleer. 
Metode hormonske kontracepcije primijenjene oralno, u obliku injekcija, implantata ili flastera nisu pouzdane u žena koje uzimaju Tracleer.
No dose adjustment is required in patients with renal impairment. 
Prilagodba doze nije potrebna kod bolesnika s oštećenjem funkcije bubrega.
After 4 weeks of bosentan 62.5 mg twice daily, the maintenance dose studied in both these studies was 
Nakon 4 tjedna primanja bosentana 62,5 mg dvaput dnevno, doza održavanja bila je 125
Package leaflet: Information for the user Tracleer 32 mg dispersible tablets 
Uputa o lijeku: Informacije za korisnika Tracleer 32 mg tablete za oralnu suspenziju bosentan
The dispersible tablet is contained in a child-proof blister. 
Tableta za oralnu suspenziju nalazi se u blisteru sigurnom za djecu.
The impact of moderately impaired liver function (Child-Pugh class B) on the pharmacokinetics of bosentan and its primary metabolite Ro 48-5033 was investigated in a study including 5 patients with pulmonary hypertension associated with portal hypertension and Child-Pugh class B hepatic impairment, and 3 patients with PAH from other causes and normal liver function. 
Ro 48-5033 istraženo je u ispitivanju koje je uključivalo 5 bolesnika sa plućnom hipertenzijom povezanom s portalnom hipertenzijom i jetrena oštećenja Child-Pugh stadija B
The NOAEL was 21 times (at Day 21 post partum) and 2.3 times (Day 69 post partum) the human therapeutic exposure, respectively. 
No observed adverse effect level) je bila 21 put (na 21. postpartalni dan) odnosno 2,3 puta (na 69.
In 20 placebo-controlled studies, conducted in a variety of therapeutic indications, a total of 2,486 patients were treated with bosentan at daily doses ranging from 100 mg to 2000 mg and 1,838 patients were treated with placebo. 
bolesnika dobivalo je bosentan u dnevnim dozama od 100 mg do 2000 mg, a 1838 bolesnika dobivalo je placebo.
Cartons contain 56 film-coated tablets (Tracleer 62.5 mg film-coated tablets). 
Kutije sadrže 56 filmom obloženih tableta (Tracleer 62,5 mg filmom obložene tablete).
Mar ______ 
Ožujak ______
Cartons contain 56 film-coated tablets (Tracleer 125 mg film-coated tablets). 
Kutije sadrže 56 filmom obloženih tableta (Tracleer 125 mg filmom obložene tablete).
Tracleer 125 mg film-coated tablets Orange-white, oval, biconvex, film-coated tablets, embossed with “125” on one side. 
Tracleer 125 mg filmom obložene tablete Narančasto-bijele, ovalne, bikonveksne filmom obložene tablete, s oznakom „125“ na jednoj strani.
At steady state, AUCτ was 6,165 ng·h/mL (CV: 133%, n = 7), which is similar to the exposure observed in adult PAH patients receiving 125 mg twice daily and taking into account a blood/plasma distribution ratio of 0.6. 
7), što je slično izloženosti zabilježenoj u odraslih bolesnika s PAH-om koji su primali 125 mg dvaput dnevno i uzimajući u obzir omjer distribucije u krvi i plazmi od 0,6.
A pooled analysis of uncontrolled paediatric studies conducted in PAH with the bosentan 32 mg dispersible tablet formulation (FUTURE 1/2, FUTURE 3/Extension) included a total of 100 children treated with bosentan 2 mg/kg twice daily (n = 33), 2 mg/kg three times daily (n = 31), or 4 mg/kg twice daily (n = 36). 
3/produžetak) uključila je ukupno 100 djece liječene bosentanom 2 mg/kg dvaput dnevno (n = 33), 2 mg/kg triput dnevno (n = 31) ili 4 mg/kg dvaput dnevno (n = 36).
Background treatments for systemic sclerosis and digital ulcers were permitted if they remained constant for at least 1 month prior to the start of treatment and during the double-blind study period. 
Dodatni lijekovi za sistemsku sklerozu i ulceracije prstiju bili su dozvoljeni ako su uzimani najmanje 1
However, Tracleer can induce hypotension (decrease of your blood pressure) which can make you feel dizzy, affect your vision and affect your ability to drive and use machines. 
Ipak, Tracleer može uzrokovati hipotenziju (pad krvnog tlaka) što može uzrokovati osjećaj omaglice,
In a randomised placebo-controlled study, conducted in PPHN patients (FUTURE-4), a total of 13 neonates were treated with the bosentan dispersible tablet formulation at a dose of 2 mg/kg twice daily (8 patients were on placebo). 
4) ukupno je 13 novorođenčadi liječeno bosentanom u obliku tablete za oralnu suspenziju u dozi od 2 mg/kg dvaput dnevno (8 bolesnika primalo je placebo).
112 film-coated tablets (Tracleer 62.5 mg film-coated tablets). 
filmom obloženih tableta (Tracleer 62,5 mg filmom obložene tablete).
Cartons contain 56 dispersible tablets. 
Kutije sadrže 56 tableta za oralnu suspenziju.
Tracleer 62.5 mg film-coated tablets are orange-white, round film-coated tablets with “62,5” on one side. 
Tracleer 62,5 mg filmom obložene tablete su narančasto-bijele, okrugle filmom obložene tablete s oznakom „62,5“ na jednoj strani.
Tracleer 62.5 mg film-coated tablets bosentan 
Tracleer 62,5 mg filmom obložene tablete bosentan
• The median time to complete weaning from mechanical ventilation was 10.8 days (95% CLs 3.21, 12.21 days) on bosentan and 8.6 days (95% CLs 3.71, 9.66 days) on placebo (p = 0.24). 
• Medijan vremena do potpunog odvikavanja od iNO bio je 3,7 dana (95% granice pouzdanosti [CL] 1,17; 6,95) uz bosentan i 2,9 dana (95% CL 1,26; 4,23) uz placebo (p = 0,34).
Of the 7 patients who deteriorated at week 8, 3 improved at week 12/16 and 4 deteriorated compared with baseline. 
3 došlo je do poboljšanja nakon 12/16 tjedana, a u 4 je došlo do pogoršanja.
Tracleer 62.5 mg film-coated tablets Orange-white, round, biconvex, film-coated tablets, embossed with “62,5” on one side. 
Tracleer 62,5 mg filmom obložene tablete Narančasto-bijele, okrugle, bikonveksne filmom obložene tablete, s oznakom „62,5“ na jednoj strani.
In the patients with Child-Pugh class B liver impairment, the mean (95% CI) steady-state AUC of bosentan was 360 (212613) ng⋅h/mL, i.e., 4.7 times higher, and the mean (95% CI) AUC of the active metabolite Ro 48-5033 was 106 (58.4-192) ng⋅h/mL, i.e., 12.4 times higher than in the patients with normal liver function (bosentan: mean [95% CI] AUC: 76.1 [9.07-638] ng⋅h/mL; Ro 48-5033: mean [95% CI] AUC 8.57 [1.28-57.2] ng⋅h/ml). 
Ro 48-5033 bio je 106 (58,4-192) ng⋅h/ml, tj. 12,4 puta viši nego kod bolesnika s normalnom funkcijom jetre (bosentan: srednji [95% CI] AUC: 76,1 [9,07-638] ng⋅h/ml; Ro 48-5033:
Do not store above 25 °C 
POSEBNE MJERE ČUVANJA Ne čuvati na temperaturi iznad 25°C
Tracleer 125 mg film-coated tablets bosentan 
Tracleer 125 mg filmom obložene tablete bosentan
Tracleer 32 mg dispersible tablets 
Tracleer 32 mg tablete za oralnu suspenziju
Tracleer 32 mg dispersible tablets bosentan 
Tracleer 32 mg tablete za oralnu suspenziju bosentan
Jul ______ 
Listopad _____
Based on the findings in studies BREATHE-3, FUTURE 1, and FUTURE-3, it appears that the exposure to bosentan reaches a plateau at lower doses in paediatric patients than in adults, and that doses higher than 2 mg/kg twice daily (4 mg/kg twice daily or 2 mg/kg three times daily) will not result in greater exposure to bosentan in paediatric patients. 
Na osnovi nalaza u studijama BREATHE-3, FUTURE 1 i FUTURE-3 pokazalo se da izloženost bosentanu doseže plato kod nižih doza u pedijatrijskih bolesnika nego u odraslih te da doze više od 2
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. 
[sildenafil] u monoterapiji [35,9%], bosentanom u monoterapiji [10,9%] i kombinacijom bosentana,
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. 
dijafragma ili kontracepcijska spužva uz bilo koju od navedenih vrsta hormonalne kontracepcije.
> 3 and ≤ 5 × ULN The result should be confirmed by a second liver test; if confirmed, a decision should be made on an individual basis to continue Tracleer, possibly at a reduced dose, or to stop Tracleer administration (see section 4.2). 
> 3 i ≤ 5 × GGN Nalaz treba potvrditi drugim testom jetrene funkcije; ako je potvrđen, donijeti odluku za svakog bolesnika ponaosob da li nastaviti liječenje
Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH. 
Plućna arterijska hipertenzija Liječenje smije započeti i nadzirati jedino liječnik s iskustvom u liječenju PAH-a.
Tracleer 125 mg film-coated tablets are orange-white, oval film-coated tablets with “125” on one side. 
Tracleer 125 mg filmom obložene tablete su narančasto bijele, okrugle filmom obložene tablete s oznakom „125“ na jednoj strani.
Each dispersible tablet contains 32 mg bosentan (as monohydrate) 
Jedna tableta za oralnu suspenziju sadrži 32 mg bosentana (u obliku bosentan hidrata)
Liver test abnormalities 
Abnormalne vrijednosti testova jetrene funkcije
Each dispersible tablet contains 32 mg bosentan (as monohydrate). 
Jedna tableta za oralnu suspenziju sadrži 32 mg bosentana (u obliku bosentan hidrata).
Feb ______ 
Svibanj ______
How to store Tracleer 
Moguće nuspojave Kako čuvati Tracleer
These will be done every month for the first 4 months of treatment, then every 3 months after that, as patients taking Tracleer may get anaemia. 
S obzirom na to da bolesnici koji uzimaju Tracleer mogu dobiti anemiju, ti nalazi provode se svakog mjeseca tijekom prva 4 mjeseca liječenja, a potom svaka 3 mjeseca.
Aug ______ 
Travanj ______
Each tablet contains 125 mg of bosentan (as monohydrate). 
Jedna tableta za oralnu suspenziju sadrži 125 mg bosentana (u obliku bosentan hidrata).
• Hypersensitivity reactions (including skin inflammation, itching and rash) 
• Reakcije preosjetljivosti (uključujući upalu, svrbež i osip na koži) • Gastroezofagealna refluksna bolest (vraćanje kiselog sadržaja iz želuca)