natgillin/translations-raw huggingface dataset:
In a pharmacokinetic crossover study (AC-052-116), 16 healthy adult subjects received 62.5 mg bosentan using the 62.5 mg film-coated tablet formulation or 64 mg bosentan using the 32 mg dispersible tablet formulation. 
U krosover ispitivanju farmakokinetike (AC-052-116), 16 zdravih odraslih ispitanika primilo je 62,5 mg bosentana u obliku 62,5 mg formulacije filmom obloženih tableta ili 64 mg bosentana u obliku 32 mg tablete za oralnu suspenziju.
Cartons contain 56 or 112 
Kutije sadrže 56 ili 112
The most frequent adverse reactions are headache (11.5%), oedema / fluid retention (13.2%), abnormal liver function test (10.9%) and anaemia / haemoglobin decrease (9.9%). 
Najčešće nuspojave bile su glavobolja (11,5%), edem / zadržavanje tekućine (13,2%), promijenjeni nalazi jetrene funkcije (10,9%) i anemija / snižene vrijednosti hemoglobina (9,9%).
Tracleer is not recommended in paediatric patients with systemic sclerosis and ongoing digital ulcer disease. 
Tracleer se ne preporučuje pedijatrijskim bolesnicima sa sistemskom sklerozom i prisutnim ulceracijama na prstima.
The dispersible tablet has been studied only in paediatric patients. 
Tableta za oralnu suspenziju ispitana je samo na pedijatrijskim bolesnicima.
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 • Moderate to severe hepatic impairment, i.e., Child-Pugh class B or C (see section 5.2) 
• Preosjetljivost na djelatnu tvar ili bilo koju od pomoćnih tvari navedenih u dijelu 6.1 • Umjereno do teško oštećenje funkcije jetre, tj. Child-Pugh stadij B ili C (vidjeti dio 5.2)
These cases reinforce the importance of strict adherence to the monthly schedule for monitoring of liver function for the duration of treatment with Tracleer (see section 4.4). 
Ti slučajevi pojačavaju važnost točnog pridržavanja mjesečnog rasporeda praćenja funkcije jetre tijekom liječenja Tracleerom (vidjeti dio
In this study there was an increased incidence of hospitalisation due to CHF during the first 4-8 weeks of treatment with bosentan, which could have been the result of fluid retention. 
U toj studiji učestalost hospitalizacije zbog kroničnog zatajenja srca tijekom prvih 4-8 tjedana liječenja bosentanom bila je povećana, što je možda bio rezultat zadržavanja tekućine.
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). 
Kod liječenja bosentanom došlo je u odnosu na placebo do smanjenja brzine pogoršanja kliničke slike, koju zajednički određuju napredovanje simptoma, hospitalizacija zbog PAH-a i smrt (smanjenje rizika za 77%, 95% interval pouzdanosti [CI] 20-94%, p = 0,0114).
If possible, you should drink a glass of water to ensure that all the medicine has been taken. 
Ako je moguće, trebali biste popiti čašu vode kako bi bili sigurni da je sav lijek progutan.
• sirolimus or tacrolimus, which are medicines used after transplants, as these are not recommended to be used together with Tracleer. 
• sirolimus ili takrolimus, lijekovi koji se uzimaju nakon transplantacije, budući da nije preporučljivo uzimati ih zajedno s Tracleerom
There are no studies to demonstrate beneficial effects of Tracleer treatment on survival. 
Ne postoje studije koje bi pokazale povoljno djelovanje liječenja Tracleerom na preživljenje bolesnika.
There is limited experience with abrupt discontinuation of Tracleer in patients with PAH. 
Postoji ograničeno iskustvo s naglim prekidom primjene Tracleera u bolesnika s PAH-om.
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-052-301/302 [ENABLE 1 & 2]).
It is important that you have these regular blood tests as long as you are taking Tracleer. 
Važno je da tijekom uzimanja Tracleera provodite redovite krvne pretrage.
In the overall population (n = 31), 2 mg/kg twice daily resulted in a daily exposure of 8,535 ng·h/mL; AUCτ was 4,268 ng·h/mL (CV: 61%). 
sveukupnoj populaciji (n = 31) primjena doze od 2 mg/kg dvaput dnevno rezultirala je dnevnom izloženošću od 8535 ng•h/mL; AUCτ je bila 4268 ng•h/mL (CV: 61%).
Concomitant use of Tracleer with glibenclamide, fluconazole and rifampicin is not recommended. 
Istodobna primjena Tracleera s glibenklamidom, flukonazolom i rifampicinom se ne preporučuje.
No recommendation on a posology can be made (see sections 5.1 and 5.2). 
Nije moguće dati preporuku o doziranju (vidjeti dijelove 5.1
The overall goal of the Patient Alert Card is to educate patients on important safety information that they need to be aware of before and during treatment with Tracleer. 
Općeniti je cilj Kartice s upozorenjima za bolesnika upoznati bolesnike s važnim sigurnosnim informacijama kojih moraju biti svjesni prije i tijekom liječenja lijekom Tracleer.
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%). 
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%).
What you need to know before you take Tracleer Do not take Tracleer: 
Što morate znati prije nego počnete uzimati Tracleer
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 je li Vam potrebna dodatna ili drugačija metoda kontracepcije.
The efficacy of Tracleer has not been established in patients with severe PAH. 
Djelotvornost Tracleera nije utvrđena u bolesnika s teškim PAH-om.
Consequently, should signs of pulmonary oedema occur when Tracleer is administered in patients with PAH, the possibility of associated veno-occlusive disease should be considered. 
Pojave li se znakovi plućnog edema kod primjene Tracleera u bolesnika s PAH-om, treba razmotriti mogućnost okluzivne bolesti vena.
Concomitant administration of both a CYP3A4 inhibitor and a CYP2C9 inhibitor with Tracleer should be avoided (see section 4.5). 
Treba izbjegavati istodobnu primjenu inhibitora CYP3A4 i CYP2C9 s Tracleerom (vidjeti dio 4.5).
Because Tracleer may make hormonal contraception (e.g., oral, injection, implant, or skin patches) ineffective, this method on its own is not reliable. 
Budući da Tracleer smanjuje učinkovitost hormonske kontracepcije (npr. tablete, u obliku injekcije, implantata ili kožnih flastera), ta metoda, samostalno primijenjena, nije sigurna.
Cyclosporine A: Co-administration of Tracleer and cyclosporine A (a calcineurin inhibitor) is contraindicated (see section 4.3). 
Ciklosporin A: istodobna primjena Tracleera i ciklosporina A (inhibitor kalcineurina) kontraindicirana je (vidjeti dio 4.3).
If possible, a glass of water should be taken to ensure that all the medicine has been ingested. 
Ako je moguće, potrebno je popiti čašu vode kako bi se osiguralo da je sav lijek progutan.
The Kaplan-Meier event-free estimate for worsening of PAH (death, lung transplantation, or hospitalisation for PAH worsening) at 2 years was 78.9%. 
Kaplan-Meierova procjena preživljenja bez događaja pogoršanja PAH-a (smrt, transplantacija pluća ili hospitalizacija zbog pogoršanja PAH-a) nakon 2 godine bila je78,9%.
Treatment with diuretics should be considered in patients with evidence of fluid retention before the start of treatment with Tracleer. 
Liječenje diureticima treba uzeti u obzir u bolesnika u kojih je već prisutno zadržavanje tekućine prije početka liječenja Tracleerom.
Patients with suboptimal response to inhaled nitric oxide (iNO) despite at least 4 hours of continuous treatment were treated with bosentan dispersible tablets at 2 mg/kg twice daily (N = 13) or placebo (N = 8) via nasogastric tube as add-on therapy on top of iNO until complete weaning of iNO or until treatment failure (defined as need for extra-corporeal membrane oxygenation [ECMO] or initiation of alternative pulmonary vasodilator), and for a maximum of 14 days. 
Bolesnici sa suboptimalnim odgovorom na udisanje dušikovog (II) oksida (engl. inhaled nitric oxide, iNO) unatoč najmanje 4 sata neprekinutog liječenja liječeni su bosentanom u obliku tableta za oralnu suspenziju u dozi od 2 mg/kg dvaput dnevno (N = 13) ili placebom (N = 8) putem nazogastrične sonde kao dodatnom terapijom uz iNO sve do potpunog odvikavanja od iNO ili do terapijskog neuspjeha (definiranog kao potreba za ekstrakorporalnom membranskom oksigenacijom [ECMO] ili uvođenjem alternativnog pulmonalnog vazodilatatora) i to najdulje 14 dana.
Your monthly liver blood test schedule: 
Raspored Vaših mjesečnih testiranja funkcije jetre:
The treatment in adults is usually started for the first 4 weeks with 62.5 mg twice daily (morning and evening), from then your doctor will usually advise you to take a 125 mg tablet twice daily, depending on how you react to Tracleer. 
Liječenje odraslih bolesnika obično započinje tijekom prva 4 tjedna dozom od 62,5 mg dva puta dnevno (ujutro i navečer), a potom će Vam liječnik vjerojatno savjetovati da uzimate 125 mg dva puta dnevno, ovisno o Vašoj reakciji na Tracleer.
No specific study has been performed in patients with pulmonary hypertension and concomitant left ventricular dysfunction. 
Nije provedena posebna studija u bolesnika s plućnom arterijskom hipertenzijom i istodobnim zatajenjem lijevog ventrikula.
The dosage of these products may need to be adjusted after initiation, dose change or discontinuation of concomitant Tracleer treatment. 
Doziranje tih lijekova treba prilagoditi nakon početka istodobnog liječenja Tracleerom, kod promjene doze ili kod prekida istodobnog liječenja Tracleerom.
Therefore, concomitant use of Tracleer and tacrolimus or sirolimus is not advisable. 
Stoga se istodobna primjena Tracleera i takrolimusa ili sirolimusa ne preporuča.
• jaundice (yellowing of your skin or the whites of your eyes) 
• žutica (žutilo kože ili bjeloočnica očiju)
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 nekontroliranog produžetka studije FUTURE 2 i za njih je medijan sveukupnog trajanja liječenja iznosio 2,3 godine (raspon 0,2 do 5,0 godina).
Tracleer reduces the number of new finger and toe ulcers that appear. 
Tracleer smanjuje pojavljivanje novih ulceracija na prstima ruku i nogu.
• Baseline values of liver aminotransferases, i.e., aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT), greater than 3 × the upper limit of normal (ULN; see section 4.4) 
• Početne vrijednosti jetrenih aminotransferaza, tj. aspartat-aminotransferaze (AST) i/ili alanin aminotransferaze (ALT), 3 × veće od gornje granice normalnih vrijednosti (GGN; vidjeti dio 4.4) • Istovremena primjena ciklosporina A (vidjeti dio 4.5)
Patients were in WHO functional class I (n = 19, 29 %), class II (n = 27, 42%) or class III (n = 18, 28%) at start of study treatment. 
stupanj II (n = 27, 42%) ili stupanj III (n = 18, 28%) na početku ispitivanog liječenja.
Transfer to a therapy that is recommended at the severe stage of the disease (e.g., epoprostenol) should be considered if the clinical condition deteriorates (see section 4.2). 
Ako se kliničko stanje pogorša, treba razmotriti prijelaz na terapiju koja se preporučuje u teškoj fazi bolesti (npr. epoprostenol) (vidjeti dio 4.2).
FUTURE 1 was an open-label, uncontrolled study that was conducted with the dispersible tablet formulation of bosentan administered at a maintenance dose of 4 mg/kg twice daily to 36 patients from 2 to 11 years of age. 
FUTURE 1 bila je otvorena nekontrolirana studija provedena s bosentanom u obliku tablete za oralnu suspenziju primijenjenim u dozi održavanja od 4 mg/kg dvaput dnevno na 36 bolesnika u dobi od 2 do
Kaplan-Meier estimates of survival were 90% and 85% at 3 and 4 years after the start of treatment, respectively. 
Kaplan-Meier procjene preživljenja bile su 90% odnosno 85% u 3. i 4. godini nakon početka liječenja.
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. 
Povećanje aminotransferaza bilo je povezano s povećanjem bilirubina (≥ 2 × GGN) bez dokaza opstrukcije žuči u 0,2% (5 bolesnika) koji su dobivali bosentan i
Bosentan film-coated tablets were evaluated in an open-label uncontrolled study in 19 paediatric patients with PAH aged 3 to 15 years. 
Bosentan u obliku filmom obloženih tableta bosentana procijenjen je u otvorenoj nekontroliranoj studiji na 19 pedijatrijskih bolesnika s PAH-om u dobi od 3 do 15 godina.
When administered concomitantly with lopinavir+ritonavir, or other ritonavir-boosted protease inhibitors, the patient's tolerability of Tracleer should be monitored. 
Kada se Tracleer primjenjuje u kombinaciji sa lopinavirom + ritonavirom ili nekim drugim inhibitorima proteaza pojačanih ritonavirom, treba pratiti bolesnikovu podnošljivost Tracleera.
In this total population, Kaplan-Meier estimates of survival were 93% and 84% 1 and 2 
U toj populaciji Kaplan-Meier procjena preživljenja bila je 93% i 84% 1, odnosno 2
Some patients taking Tracleer were found to have abnormal liver function tests. 
Kod nekih bolesnika koji uzimaju Tracleer utvrđeni su abnormalni testovi funkcije jetre te anemija
Tests your doctor will do during treatment 
Nalazi koje će Vaš liječnik zatražiti prije liječenja
Appropriate precautions must be taken for women of childbearing potential (see sections 4.3, 4.4 and 4.6). 
U žena reproduktivne treba poduzeti odgovarajuće mjere opreza (vidjeti dijelove 4.3, 4.4 i 4.6).
How to take Tracleer 
Kako uzimati Tracleer
These elevations in aminotransferases may reverse spontaneously while continuing treatment with the maintenance dose of Tracleer 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).
For children aged 1 year and older, treatment with Tracleer is usually started with 2 mg per kg bodyweight twice daily (morning and evening). 
Za djecu u dobi od 1 godine i stariju liječenje Tracleerom obično se započinje dozom od 2 mg po kg tjelesne težine dva puta dnevno (ujutro i navečer).
In the FUTURE-4 study including 13 neonates with PPHN treated with bosentan 2 mg/kg twice daily for less than 10 days (range 0.5-10.0 days), there were no cases of liver aminotransferases ≥ 3 × ULN during treatment, but one case of hepatitis occurred 3 days after the end of bosentan treatment. 
U FUTURE-4 studiji koja je uključila 13 novorođenčadi s PPHN-om liječene bosentanom u dozi od 2 mg/kg dvaput dnevno kraće od 10 dana (raspon 0,5-10,0 dana), nije bilo slučajeva s porastom razine jetrenih aminotransferaza ≥ 3 × GGN tijekom liječenja, ali se pojavio jedan slučaj hepatitisa 3 dana nakon završetka liječenja bosentanom.
In the post-marketing period rare cases of unexplained hepatic cirrhosis were reported after prolonged therapy with Tracleer in patients with multiple co-morbidities and therapies with medicinal products. 
U postmarketinškom razdoblju prijavljeni su rijetki slučajevi neobjašnjive ciroze jetre nakon produljene terapije s Tracleerom u bolesnika s višestrukim istodobnim pobolijevanjima i terapijama lijekovima.
• Flushed appearance or redness of skin 
• Pojava rumenila u licu ili crvenila na koži
Separate into halves by breaking the tablet along the break-marks (see figure below). 
Prelomite na pola duž linije (vidjeti sliku ispod).
Tracleer contains sodium 
Tracleer sadrži natrij
2 Hypersensitivity reactions were reported in 9.9% of patients on bosentan and 9.1% of patients on placebo. 
2 Reakcije preosjetljivosti prijavljene su u 9,9% bolesnika koji su dobivali bosentan i u 9,1% bolesnika koji su dobivali placebo.
If necessary, the dispersible tablet can be divided by breaking along the lines cut into the surface. 
Ako je potrebno, tableta za oralnu suspenziju može se razdijeliti lomljenjem duž crta urezanih na površini.
- The active substance is bosentan as monohydrate. 
- Djelatna tvar je bosentan u obliku bosentan hidrata.
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). 
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).
5 Oedema or fluid retention was reported in 13.2% of patients on bosentan and 10.9% of patients on placebo. 
5 Edem ili retencija tekućine prijavljeni su u 13,2% bolesnika koji su dobivali bosentan i 10,9% bolesnika koji su dobivali placebo.
• The median time to complete weaning from iNO was 3.7 days (95% confidence limits [CLs] 1.17, 6.95) on bosentan and 2.9 days (95% CLs 1.26, 4.23) on placebo (p = 0.34). 
• Medijan vremena do potpunog odvikavanja od iNO bio je 3,7 dana (95% granica pouzdanosti [CL] 1,17; 6,95) uz bosentan i 2,9 dana (95% CL 1,26; 4,23) uz placebo (p = 0,34).
Peel off the top layer. 
Uklonite gornji sloj.
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 temelju tih farmakokinetičkih rezultata, preporučena početna doza i doza održavanja u djece s PAH-om u dobi od 1 godine i starije iznosi 2 mg/kg ujutro i uvečer.
In the 20 integrated placebo-controlled studies, elevations in liver aminotransferases ≥ 3 × ULN were observed in 11.2% of the bosentan-treated patients as compared to 2.4% of the placebo-treated patients. 
U 20 integriranih placebom kontroliranih studija povišenje jetrenih aminotransferaza ≥ 3 × u odnosu na GGN primijećeno je u 11,2% bolesnika koji su dobivali bosentan u odnosu na 2,4% bolesnika koji su dobivali placebo.
Study AC-052-356 (BREATHE-3) evaluated the pharmacokinetics of single and multiple oral doses of the film-coated tablet formulation of bosentan in 19 children aged from 3 to 15 years with PAH who were dosed on the basis of body weight with 2 mg/kg twice daily. 
Studija AC-052-356 (BREATHE-3) procijenila je farmakokinetiku pojedinačnih i višekratnih oralnih doza bosenatana u obliku filmom obloženih tableta u 19 djece u dobi od 3 do 15 godina s PAH-om koji su dobivali dozu na temelju njihove tjelesne težine od 2 mg/kg dvaput dnevno.
14 film-coated tablets 56 film-coated tablets 112 film-coated tablets 
14 filmom obloženih tableta 56 filmom obloženih tableta 112 filmom obloženih tableta
Pale yellow to off-white, clover-shape tablets, quadrisected on one side and debossed with “32” on the other side. 
Blijedo žute do gotovo bijele tablete oblika djeteline, s razdjelnim urezima na četvrtine s jedne strane i s oznakom „32“ s druge strane.
Inside your pack of Tracleer 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.
The film-coat contains hypromellose, glycerol triacetate, talc, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172) and ethylcellulose. 
Film ovojnica sadrži hipromelozu, glicerol triacetat, talk, titanijev diokisid (E171), željezov oksid žuti (E172), željezov oksid crveni (E172) i etilcelulozu.
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 kompetetivnom inhibicijom eliminacije žučnih soli iz hepatocita, kao i drugim, još neutvrđenim mehanizmima poremećaja funkcije jetre.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON WITH 14, 56 AND 112 TABLETS 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PAKIRANJE S 14, 56 I 112 TABLETA
Cartons contain 14, 56 or 112 film-coated tablets. 
Kutije sadrže 14, 56 ili 112 filmom obloženih tableta.
Do not store above 30 °C 
Ne čuvati na temperaturi iznad 30°C.
In this total population, Kaplan-Meier estimates of survival were 93% and 84% 1 and 2 years after the start of treatment with bosentan, respectively. 
U toj populaciji Kaplan-Meier procjena preživljenja bila je 93% i 84% 1, odnosno 2 godine od početka liječenja bosentanom.
In the pooled analysis of 100 PAH children from uncontrolled paediatric studies FUTURE 1/2 and FUTURE 3/Extension, elevations in liver aminotransferases ≥ 3 × ULN were observed in 2% of patients. 
U analizi objedinjenih podataka 100 djece s PAH-om iz nekontroliranih pedijatrijskih studija FUTURE 1/2 i FUTURE 3/produžetak, zabilježen je porast razine jetrenih aminotransferaza ≥ 3 × GGN u 2% bolesnika.
Hormonal contraceptives: Co-administration of bosentan 125 mg twice daily for 7 days with a single dose of oral contraceptive containing norethisterone 1 mg + ethinyl estradiol 35 mcg decreased the AUC of norethisterone and ethinyl estradiol by 14% and 31%, respectively. 
Hormonski kontraceptivi: istodobna primjena bosentana 125 mg dvaput dnevno tijekom 7 dana s jednokratnom dozom oralnog kontraceptiva koji sadrži noretisteron 1 mg i etinilestradiol 35 μg,
The dispersible tablets should be added to a little water on a spoon, and the liquid stirred to aid dissolution, before swallowing. 
Tablete za oralnu suspenziju prije gutanja treba dodati u malo vode na žlici i tekućinu promješati kako bi se pospješilo otapanje.
In the post-marketing period there have been rare reports of pulmonary oedema in patients treated with Tracleer who had a suspected diagnosis of pulmonary veno-occlusive disease. 
U postmarketinškom razdoblju rijetko su zabilježeni slučajevi plućnog edema u bolesnika koji su dobivali Tracleer i u kojih je postojala sumnja na okluzivnu bolest plućnih vena.
If the aminotransferase levels return to pre-treatment values continuing or reintroducing Tracleer according to the conditions described below should be considered. 
Ako se vrijednosti aminotransferaza vrate na vrijednosti prije liječenja, treba razmotriti nastavak ili ponovno liječenje Tracleerom u skladu s dolje navedenim uvjetima.
Concomitant use of rifampicin and Tracleer is not recommended. 
Istodobna primjena rifampicina i Tracleera nije preporučljiva.
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 u WHO funkcionalnog stupnja II (n = 15, 79%) ili stupnja III (n = 4, 21%) na početku studije.
Aluminium/Aluminium peel-push blisters containing 14 dispersible tablets. 
Aluminij/aluminij blisteri koji sadrže 14 tableta za oralnu suspenziju.