FrancophonIA/ELRC3.0 huggingface dataset:
English: Some patients not responding well to 125 mg twice daily of Tracleer may slightly improve their exercise capacity when the dose is increased to 250 mg twice daily.
Croatian: Kod nekih bolesnika koji ne reagiraju dobro na 125 mg Tracleera dvaput dnevno, može doći do blagog poboljšanja kapaciteta fizičkog opterećenja kada se doza poveća na 250 mg dvaput dnevno.
English: Push the pharmaceutical product through the foil.
Croatian: 3. Protisnite lijek kroz foliju.
English: A bioavailability comparison between dispersible tablets and film-coated tablets performed in adult subjects indicated lower exposure to bosentan with the dispersible tablet (see section 5.2).
Croatian: Usporedba bioraspoloživosti provedena između tableta za oralnu suspenziju i filmom obloženih tableta kod odraslih bolesnika ukazala je na manju izloženost bosentanu kad se radilo o tableti za oralnu suspenziju (vidjeti dio 5.2).
English: Therefore, you must not take Tracleer if you are pregnant and you must also not become pregnant while taking Tracleer.
Croatian: Zbog toga ne smijete uzimati Tracleer ako ste trudni te ne smijete zatrudnijeti tijekom uzimanja Tracleera.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Croatian: Detaljnje informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: Pharmacokinetic data are not available for Tracleer in young children with this disease.
Croatian: Nema farmakokinetičkih podataka za lijek Tracleer kod male djece s ovom bolešću.
English: If you stop taking Tracleer
Croatian: Ako prestanete uzimati Tracleer
English: An open-label, non-comparative study (AC-052-362 [BREATHE-4]) was performed in 16 patients with WHO functional class III PAH associated with HIV infection.
Croatian: Otvorena, nekomparativna studija (AC-052-362 [BREATHE-4]) provedena je na 16 bolesnika s PAH-om WHO funkcionalnog stupnja III povezanom s HIV-infekcijom.
English: Slightly increased incidence of testicular tubular atrophy was observed in rats given bosentan orally at doses as low as 125 mg/kg/day (about 4 times the maximum recommended human dose [MRHD] and the lowest doses tested) for two years but not at doses as high as 1,500 mg/kg/day (about 50 times the MRHD) for 6 months.
Croatian: Uočena je lagano povećana incidencija tubularne atrofije testisa u štakora koji su primali bosentan peroralno u niskim dozama od 125 mg/kg/dan (otprilike 4 puta više od maksimalne preporučene doze za ljude [MRHD, engl. maximum recommended human dose] i najniža ispitivana doza) tijekom dvije godine, ali ne i pri visokim dozama od 1500 mg/kg/dan (otprilike 50 puta više od MRHD) tijekom 6
English: In vitro, bosentan inhibits the bile salt export pump in hepatocyte cultures.
Croatian: bosentan inhibira eksportnu crpku za žučne soli u kulturama hepatocita.
English: Tracleer is contraindicated in patients with moderate to severe liver dysfunction (see sections 4.3, 4.4 and 5.2).
Croatian: Tracleer je kontraindiciran kod bolesnika s umjerenom do teškom disfunkcijom jetre (vidjeti dijelove 4.3, 4.4 i 5.2).
English: Paediatric pharmacokinetic data have shown that bosentan plasma concentrations in children with PAH aged from 1 year to 15 years were on average lower than in adult patients and were not increased by increasing the dose of Tracleer above 2 mg/kg body weight or by increasing the dosing frequency from twice daily to three times daily (see section 5.2).
Croatian: Pedijatrijski farmakokinetički podaci pokazali su da su koncentracije bosentana u plazmi kod djece s PAH-om u dobi od 1 do 15 godina u prosjeku bile niže nego kod odraslih bolesnika i nisu se povećale povećanjem doze Tracleera iznad 2 mg/kg tjelesne težine ili povećanjem učestalosti doziranja s dvaput dnevno na triput dnevno (vidjeti dio 5.2).
English: The safety profile in this pooled analysis of uncontrolled paediatric studies was similar to that observed in the pivotal trials in adult patients with PAH except for infections, which were more frequently reported than in adults (69.0% vs 41.3%).
Croatian: Sigurnosni profil u ovoj analizi združenih podataka iz nekontroliranih pedijatrijskih studija bio je sličan u onome opaženom u pivotalnim studijama u odraslih bolesnika s PAH-om, osim za infekcije koje su bile češće zabilježene nego u odraslih (69,0% naspram 41,3%).
English: In study AC-052-391 (FUTURE 4) conducted in neonates, bosentan concentrations increased slowly and continuously over the first dosing interval, resulting in low exposure (AUC0-12 in whole blood: 164 ng·h/mL, n = 11).
Croatian: U studiji AC-052-391 (FUTURE 4) provedenoj na novorođenčadi, koncentracije bosentana rasle su polako i neprekidno tijekom prvog intervala doziranja dovodeći do niske izloženosti (AUC0-12 u punoj krvi: 164 ng•h/mL, n = 11).
English: Your liver and blood values will be monitored during treatment with Tracleer (see section 2).
Croatian: Funkcija jetre i krvna slika će se pratiti za vrijeme liječenja Tracleerom (pogledajte dio 2).
English: Tracleer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease (see section 5.1).
Croatian: Tracleer je također indiciran za smanjenje broja novih ulceracija na prstima kod bolesnika sa sistemskom sklerozom i aktivnom bolešću ulceracija prstiju (vidjeti dio 5.1).
English: • Elevated liver function tests with hepatitis (inflammation of the liver) including possible exacerbation of underlying hepatitis and/or jaundice (yellowing of the skin or the whites of the eyes)
Croatian: • Povišene vrijednosti testova jetrene funkcije s hepatitisom (upala jetre) uključujući moguće pogoršanje podležećeg hepatitisa i/ili žuticom (žutilo kože ili bjeloočnica)
English: Tracleer 62.5 mg film-coated tablets EU/1/02/220/001
Croatian: Tracleer 62,5 mg filmom obložene tablete EU/1/02/220/001
English: • cyclosporine A (a medicine used after transplants and to treat psoriasis), which must not be used together with Tracleer.
Croatian: • ciklosporin A (lijek koji se uzima nakon transplantacije i za liječenje psorijaze) koji se ne smije koristiti zajedno s Tracleerom
English: Tracleer has not been shown to have a beneficial effect on the healing of existing digital ulcers.
Croatian: Za Tracleer nije pokazano da je učinkovit u zacjeljivanju postojećih ulceracija prstiju.
English: Each dispersible tablet can be dissolved in water to make a liquid medicine, by adding the tablet to a little water on a spoon, using enough water to cover the whole tablet.
Croatian: Kako bi se napravio lijek u tekućem obliku, svaka tableta za oralnu suspenziju može se otopiti u vodi stavljanjem tablete na žlicu s malo vode, ali koristeći pritom dovoljno vode kako bi se prekrila cijela tableta.
English: There is limited clinical study experience with the use of Tracleer in patients with PAH associated with HIV infection, treated with antiretroviral medicinal products (see section 5.1).
Croatian: Iskustvo iz kliničke studije s primjenom Tracleera u bolesnika s PAH-om povezanom s HIVinfekcijom koja je liječena antiretrovirusnim lijekovima ograničeno je (vidjeti dio 5.1).
English: Before the initiation of Tracleer treatment in women of childbearing potential, the absence of pregnancy should be checked, appropriate advice on reliable methods of contraception provided, and reliable contraception initiated.
Croatian: Prije početka liječenja Tracleerom žena reproduktivne dobi treba provjeriti da nisu trudne, dati im odgovarajuće savjete o pouzdanim metodama kontracepcije i inicirati pouzdanu kontracepciju.
English: When treatment with Tracleer is initiated in patients who require ritonavir-boosted protease inhibitors, the patient's tolerability of Tracleer should be closely monitored with special attention, at the beginning of the initiation phase, to the risk of hypotension and to liver function tests.
Croatian: Kada je terapija Tracleerom započeta kod bolesnika koji zahtijevaju liječenje ritonavirom inhibitorom proteaze, bolesnikovu podnošljivost Tracleera treba pomno pratiti s posebnom pažnjom na početku faze uvođenja, s obzirom na rizik od hipotenzije i nalaze funkcije jetre.
English: Systemic sclerosis with ongoing digital ulcer disease Treatment should only be initiated and monitored by a physician experienced in the treatment of systemic sclerosis.
Croatian: Sistemska skleroza s aktivnom bolešću ulceracija prstiju Liječenje smije započeti i nadzirati samo liječnik s iskustvom u liječenju sistemske skleroze.
English: • glibenclamide (a diabetes medicine), rifampicin (a tuberculosis medicine), fluconazole (a medicine against fungal infections), ketoconazole (a medicine used to treat Cushing's syndrome), or nevirapine (an HIV medicine), as these medicines are not recommended to be used together with Tracleer.
Croatian: • glibenklamid (lijek za dijabetes), rifampicin (lijek za tuberkulozu), flukonazol (lijek za gljivične infekcije), ketokonazol (lijek za liječenje Cushingovog sindroma) ili nevirapin (za liječenje HIV infekcije) budući da nije preporučljivo uzimati te lijekove zajedno s Tracleerom
English: No dose proportionality was observed, as steady-state bosentan plasma concentrations and AUCs were similar at oral doses of 2 and 4 mg/kg (AUCτ: 3,577 ng·h/mL and 3,371 ng·h/mL for 2 mg/kg twice daily and 4 mg/kg twice daily, respectively).
Croatian: Nije primijećena proporcionalnost s dozom budući da su koncentracija bosentana u plazmi i AUC u stanju dinamičke ravnoteže bili slični kod doza od 2 i 4 mg/kg primijenjenih peroralno (AUCτ: 3577 ng•h/mL za 2 mg/kg dvaput dnevno i 3371 ng•h/mL za 4 mg/kg dvaput dnevno).
English: 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.
Croatian: 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.
English: Cartons contain 56 or 112
Croatian: Kutije sadrže 56 ili 112
English: 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%).
Croatian: 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%).
English: Tracleer is not recommended in paediatric patients with systemic sclerosis and ongoing digital ulcer disease.
Croatian: Tracleer se ne preporučuje pedijatrijskim bolesnicima sa sistemskom sklerozom i prisutnim ulceracijama na prstima.
English: The dispersible tablet has been studied only in paediatric patients.
Croatian: Tableta za oralnu suspenziju ispitana je samo na pedijatrijskim bolesnicima.
English: • 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)
Croatian: • 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)
English: 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).
Croatian: Ti slučajevi pojačavaju važnost točnog pridržavanja mjesečnog rasporeda praćenja funkcije jetre tijekom liječenja Tracleerom (vidjeti dio
English: 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.
Croatian: 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.
English: 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).
Croatian: 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).
English: If possible, you should drink a glass of water to ensure that all the medicine has been taken.
Croatian: Ako je moguće, trebali biste popiti čašu vode kako bi bili sigurni da je sav lijek progutan.
English: • sirolimus or tacrolimus, which are medicines used after transplants, as these are not recommended to be used together with Tracleer.
Croatian: • sirolimus ili takrolimus, lijekovi koji se uzimaju nakon transplantacije, budući da nije preporučljivo uzimati ih zajedno s Tracleerom
English: There are no studies to demonstrate beneficial effects of Tracleer treatment on survival.
Croatian: Ne postoje studije koje bi pokazale povoljno djelovanje liječenja Tracleerom na preživljenje bolesnika.
English: There is limited experience with abrupt discontinuation of Tracleer in patients with PAH.
Croatian: Postoji ograničeno iskustvo s naglim prekidom primjene Tracleera u bolesnika s PAH-om.
English: 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]).
Croatian: 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]).
English: It is important that you have these regular blood tests as long as you are taking Tracleer.
Croatian: Važno je da tijekom uzimanja Tracleera provodite redovite krvne pretrage.
English: 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%).
Croatian: 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%).
English: Concomitant use of Tracleer with glibenclamide, fluconazole and rifampicin is not recommended.
Croatian: Istodobna primjena Tracleera s glibenklamidom, flukonazolom i rifampicinom se ne preporučuje.
English: No recommendation on a posology can be made (see sections 5.1 and 5.2).
Croatian: Nije moguće dati preporuku o doziranju (vidjeti dijelove 5.1
English: 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.
Croatian: Općeniti je cilj Kartice s upozorenjima za bolesnika upoznati bolesnike s važnim sigurnosnim informacijama kojih moraju biti svjesni prije i tijekom liječenja lijekom Tracleer.
English: 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%).
Croatian: 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%).
English: What you need to know before you take Tracleer Do not take Tracleer:
Croatian: Što morate znati prije nego počnete uzimati Tracleer
English: 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.
Croatian: 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.
English: The efficacy of Tracleer has not been established in patients with severe PAH.
Croatian: Djelotvornost Tracleera nije utvrđena u bolesnika s teškim PAH-om.
English: 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.
Croatian: Pojave li se znakovi plućnog edema kod primjene Tracleera u bolesnika s PAH-om, treba razmotriti mogućnost okluzivne bolesti vena.
English: Concomitant administration of both a CYP3A4 inhibitor and a CYP2C9 inhibitor with Tracleer should be avoided (see section 4.5).
Croatian: Treba izbjegavati istodobnu primjenu inhibitora CYP3A4 i CYP2C9 s Tracleerom (vidjeti dio 4.5).
English: Because Tracleer may make hormonal contraception (e.g., oral, injection, implant, or skin patches) ineffective, this method on its own is not reliable.
Croatian: Budući da Tracleer smanjuje učinkovitost hormonske kontracepcije (npr. tablete, u obliku injekcije, implantata ili kožnih flastera), ta metoda, samostalno primijenjena, nije sigurna.
English: Cyclosporine A: Co-administration of Tracleer and cyclosporine A (a calcineurin inhibitor) is contraindicated (see section 4.3).
Croatian: Ciklosporin A: istodobna primjena Tracleera i ciklosporina A (inhibitor kalcineurina) kontraindicirana je (vidjeti dio 4.3).
English: If possible, a glass of water should be taken to ensure that all the medicine has been ingested.
Croatian: Ako je moguće, potrebno je popiti čašu vode kako bi se osiguralo da je sav lijek progutan.
English: The Kaplan-Meier event-free estimate for worsening of PAH (death, lung transplantation, or hospitalisation for PAH worsening) at 2 years was 78.9%.
Croatian: Kaplan-Meierova procjena preživljenja bez događaja pogoršanja PAH-a (smrt, transplantacija pluća ili hospitalizacija zbog pogoršanja PAH-a) nakon 2 godine bila je78,9%.
English: Treatment with diuretics should be considered in patients with evidence of fluid retention before the start of treatment with Tracleer.
Croatian: Liječenje diureticima treba uzeti u obzir u bolesnika u kojih je već prisutno zadržavanje tekućine prije početka liječenja Tracleerom.
English: 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.
Croatian: 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.
English: Your monthly liver blood test schedule:
Croatian: Raspored Vaših mjesečnih testiranja funkcije jetre:
English: 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.
Croatian: 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.
English: No specific study has been performed in patients with pulmonary hypertension and concomitant left ventricular dysfunction.
Croatian: Nije provedena posebna studija u bolesnika s plućnom arterijskom hipertenzijom i istodobnim zatajenjem lijevog ventrikula.
English: The dosage of these products may need to be adjusted after initiation, dose change or discontinuation of concomitant Tracleer treatment.
Croatian: Doziranje tih lijekova treba prilagoditi nakon početka istodobnog liječenja Tracleerom, kod promjene doze ili kod prekida istodobnog liječenja Tracleerom.
English: Therefore, concomitant use of Tracleer and tacrolimus or sirolimus is not advisable.
Croatian: Stoga se istodobna primjena Tracleera i takrolimusa ili sirolimusa ne preporuča.
English: • jaundice (yellowing of your skin or the whites of your eyes)
Croatian: • žutica (žutilo kože ili bjeloočnica očiju)
English: 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).
Croatian: 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).
English: Tracleer reduces the number of new finger and toe ulcers that appear.
Croatian: Tracleer smanjuje pojavljivanje novih ulceracija na prstima ruku i nogu.
English: • 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)
Croatian: • 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)
English: 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.
Croatian: stupanj II (n = 27, 42%) ili stupanj III (n = 18, 28%) na početku ispitivanog liječenja.
English: 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).
Croatian: Ako se kliničko stanje pogorša, treba razmotriti prijelaz na terapiju koja se preporučuje u teškoj fazi bolesti (npr. epoprostenol) (vidjeti dio 4.2).
English: 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.
Croatian: 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
English: Kaplan-Meier estimates of survival were 90% and 85% at 3 and 4 years after the start of treatment, respectively.
Croatian: Kaplan-Meier procjene preživljenja bile su 90% odnosno 85% u 3. i 4. godini nakon početka liječenja.
English: 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.
Croatian: Povećanje aminotransferaza bilo je povezano s povećanjem bilirubina (≥ 2 × GGN) bez dokaza opstrukcije žuči u 0,2% (5 bolesnika) koji su dobivali bosentan i
English: Bosentan film-coated tablets were evaluated in an open-label uncontrolled study in 19 paediatric patients with PAH aged 3 to 15 years.
Croatian: 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.
English: When administered concomitantly with lopinavir+ritonavir, or other ritonavir-boosted protease inhibitors, the patient's tolerability of Tracleer should be monitored.
Croatian: Kada se Tracleer primjenjuje u kombinaciji sa lopinavirom + ritonavirom ili nekim drugim inhibitorima proteaza pojačanih ritonavirom, treba pratiti bolesnikovu podnošljivost Tracleera.