FrancophonIA/ELRC3.0 huggingface dataset:
English: No dose adjustment is needed for warfarin and similar oral anticoagulant agents when bosentan is initiated, but intensified monitoring of INR is recommended, especially during bosentan initiation and the up-titration period.
Slovenian: Za varfarin in podobne peroralne antikoagulante ob začetku zdravljenja z bosentanom prilagajanje odmerka ni potrebno, priporočamo pa pogostejše spremljanje INR, še zlasti med uvajanjem in višanjem odmerka bosentana.
English: 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.
Slovenian: Na podlagi teh farmakokinetičnih rezultatov pri uporabi pri otrocih s PAH, starih 1 leto in več, je priporočeni začetni in vzdrževalni odmerek 2 mg/kg zjutraj in zvečer..
English: It is important that you have these regular blood tests as long as you are taking Tracleer.
Slovenian: Pomembno je, da redno opravljate preiskave krvi v času jemanja zdravila Tracleer.
English: Tracleer may harm the development of the foetus.
Slovenian: Zdravilo Tracleer lahko škoduje razvoju ploda.
English: Though the number of patients included was limited and with high variability, these data indicate a marked increase in the exposure to bosentan and its primary metabolite Ro 485033 in patients with moderate liver function impairment (Child-Pugh class B).
Slovenian: Čeprav je bilo število vključenih bolnikov omejeno in so se med seboj močno razlikovali, nakazujejo ti podatki na veliko povešanje izpostavljenosti bosentanu in njegovemu primarnemu presnovku Ro 48-5033 pri bolnikih z zmerno okvaro delovanja jeter (razred B po klasifikaciji Child-Pugh).
English: In fertility studies in male and female rats, no effects on sperm count, motility and viability, or on mating performance or fertility were observed at exposures that were 21 and 43 times the expected therapeutic level in humans, respectively; nor was there any adverse effect on the development of the pre-implantation embryo or on implantation.
Slovenian: gibljivost in preživetje spermijev ali na uspešnost parjenja ali plodnost, pri izpostavljenostih, ki so bile 21-krat in 43-krat višje od pričakovane terapevtske ravni pri ljudeh, niti ni bilo nobenega neželenega učinka na razvoj zarodka pred ugnezditvijo ali na ugnezditev samo.
English: Tracleer tablets contain bosentan, which blocks a naturally occurring hormone called endothelin-1 (ET-1), which causes blood vessels to narrow.
Slovenian: Tablete zdravila Tracleer vsebujejo bosentan, ki zavre naravni hormon, imenovan endotelin-1 (ET-1),
English: Tracleer is not recommended in paediatric patients with systemic sclerosis and ongoing digital ulcer disease.
Slovenian: Uporaba zdravila Tracleer se ne priporoča pri pediatričnih bolnikih s sistemsko sklerozo in napredujočo boleznijo razjed prstov.
English: Tracleer 62.5 mg film-coated tablets EU/1/02/220/001
Slovenian: Tracleer 62,5 mg filmsko obložene tablete EU/1/02/220/001
English: • sirolimus or tacrolimus, which are medicines used after transplants, as these are not recommended to be used together with Tracleer.
Slovenian: • sirolimus ali takrolimus, zdravili, ki se uporabljata pri presaditvah, saj se njuna uporaba skupaj z zdravilom Tracleer ne priporoča,
English: CL = confidence limit; PVR = pulmonary vascular resistance; SD = standard deviation.
Slovenian: MZ = meja zaupanja, PŽU = pljučno-žilni upor, SD = standardna deviacija
English: Tracleer has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Tracleer nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: PATIENT ALERT CARD
Slovenian: OPOZORILNA KARICA ZA BOLNIKA
English: The pharmacokinetics of bosentan have mainly been documented in healthy subjects.
Slovenian: Farmakokinetiko bosentana so preučevali zlasti pri zdravih osebah.
English: There was no relevant difference in adverse event frequencies between patients above and below the age of 2 years; however, this is based on only 21 children less than 2 years, including 6 patients between 3 months to 1 year of age.
Slovenian: Ni bilo pomembne razlike v pogostnosti neželenih učinkov med bolniki, starejšimi in mlajšimi od 2 let, vendar ta ugotovitev temelji le na 21 bolnikih, mlajših od 2 let, vključno s 6 bolniki, starimi od 3 mesecev do 1 leta.
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.
Slovenian: Pred začetkom zdravljenja z zdravilom Tracleer je treba pri ženskah v rodni dobi izključiti nosečnost, jim nuditi ustrezen nasvet v zvezi z zanesljivimi načini kontracepcije in začeti z zanesljivo kontracepcijo.
English: During treatment with Tracleer, your doctor will arrange for regular blood tests to check for changes in your liver function and haemoglobin level.
Slovenian: Med zdravljenjem z zdravilom Tracleer bo vaš zdravnik odredil redne krvne preiskave, s katerimi bo nadziral spremembe v delovanju vaših jeter in v ravni hemoglobina.
English: Hypotension1, 4
Slovenian: Pogosti hipotenzija1, 4
English: After 4 weeks of bosentan 62.5 mg twice daily, the maintenance doses studied in these studies were 125 mg twice daily in AC-052-351, and 125 mg twice daily and 250 mg twice daily in AC-052-352.
Slovenian: Po 4 tednih jemanja bosentana v odmerku 62,5 mg dvakrat na dan so bili vzdrževalni odmerki, preučevani v teh študijah, 125 mg dvakrat na dan v AC-052-351 ter odmerek 125 mg dvakrat na dan in 250 mg dvakrat na dan v AC-052-352.
English: Do not store above 30 °C
Slovenian: Shranjujte pri temperaturi do 30 °C
English: • flu-like syndrome (joint and muscle pain with fever)
Slovenian: • gripi podobni sindromi (bolečine sklepov in mišic z zvišano telesno temperaturo)
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).
Slovenian: Sorazmernosti odmerka niso opazili, saj so bile koncentracije bosentana v plazmi v stanju dinamičnega ravnovesja in AUCτ pri peroralnih odmerkih 2 in 4 mg/kg podobne (AUCτ: 3.577 ng·h/ml pri 2 mg/kg dvakrat dnevno in 3.371 ng·h/ml pri 4 mg/kg dvakrat dnevno).
English: To remove the dispersible tablet:
Slovenian: Odstranitev disperzibilne tablete:
English: The efficacy of Tracleer has not been established in patients with severe PAH.
Slovenian: Učinkovitost zdravila Tracleer pri bolnikih s hudo PAH ni bila ugotovljena.
English: Tracleer is contraindicated in patients with moderate to severe hepatic impairment, i.e., Child-Pugh class B or C (see section 4.3).
Slovenian: Zdravilo Tracleer je kontraindicirano pri bolnikih z zmerno do hudo okvaro jeter, tj. razreda B ali C po klasifikaciji Child-Pugh (glejte poglavje 4.3).
English: Pharmacokinetic data are not available for Tracleer in young children with this disease.
Slovenian: Tracleer pri majhnih otrocih s to boleznijo niso na voljo.
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).
Slovenian: O uporabi zdravila Tracleer pri bolnikih s PAH, povezanim z okužbo s HIV, ki se zdravijo s protiretrovirusnimi zdravili, imamo omejene izkušnje iz kliničnih študij (glejte poglavje 5.1).
English: Tmax and t1/2 of bosentan were not significantly affected by the formulation.
Slovenian: Formulacija ni bistveno vplivala na Tmax in t1/2 bosentana.
English: 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.
Slovenian: Hormonske kontracepcijske metode, kot so peroralni kontraceptivi ali kontracepcijske tabletke, hormonske injekcije, vsadki ali kožni obliži nosečnosti ne preprečujejo zanesljivo pri ženskah, ki jemljejo zdravilo Tracleer.
English: If the aminotransferase levels return to pre-treatment values continuing or reintroducing Tracleer according to the conditions described below should be considered.
Slovenian: Če se ravni aminotransferaz vrnejo na vrednosti pred zdravljenjem, je treba presoditi o nadaljevanju ali ponovni uvedbi zdravljenja z zdravilom Tracleer v skladu s spodaj opisanimi pogoji.
English: If necessary, the dispersible tablet can be divided by breaking along the lines cut into the surface.
Slovenian: Po potrebi lahko disperzibilno tableto prelomite po črtah, vtisnjenih v površino.
English: If possible, you should drink a glass of water to ensure that all the medicine has been taken.
Slovenian: Če je možno, spijte kozarec vode in zagotovi zaužitje celotnega zdravila.
English: • cyclosporine A (a medicine used after transplants and to treat psoriasis), which must not be used together with Tracleer.
Slovenian: • ciklosporin A (zdravilo, ki se uporablja po presaditvah in za zdravljenje luskavice), ki ga ne smete uporabljati skupaj z zdravilom Tracleer,
English: When administered concomitantly with lopinavir+ritonavir, or other ritonavir-boosted protease inhibitors, the patient's tolerability of Tracleer should be monitored.
Slovenian: Pri sočasnem dajanju lopinavirja in ritonavirja ali drugih zaviralcev proteaze, ki jih okrepi ritonavir, je treba nadzirati prenašanje zdravila Tracleer pri bolniku.
English: Because Tracleer may make hormonal contraception (e.g., oral, injection, implant, or skin patches) ineffective, this method on its own is not reliable.
Slovenian: Ker lahko zdravilo Tracleer povzroči neučinkovitost hormonske kontracepcije (npr. peroralne, oblike za injiciranje, vsadki ali kožni obliž), ta način sam ni zanesljiv.
English: Of the 7 patients who deteriorated at week 8, 3 improved at week 12/16 and 4 deteriorated compared with baseline.
Slovenian: Od 7 bolnikov s poslabšanjem stanja v 8. tednu, se je pri 3 bolnikih stanje izboljšalo v 12./16.
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).
Slovenian: Zdravilo Tracleer se uporablja tudi za zmanjševanje števila novih razjed prstov pri bolnikih s sistemsko sklerozo in nastajajočimi razjedami prstov (glejte poglavje 5.1).
English: At baseline, patients had idiopathic (31 patients [86%]) or familial (5 patients [14%]) PAH, and were in WHO functional class II (n = 23, 64%) or class III (n = 13, 36%).
Slovenian: V izhodišču so bolniki imeli idiopatsko (31 bolnikov [86 %] ali družinsko (5 bolnikov [14 %] ) PAH, in so bili po klasifikaciji SZO v II.
English: Following treatment with the dispersible tablet, exposure to bosentan was lower than with the film-coated tablet (ratio of geometric means for AUC0-∞ 0.87 [90% CI: 0.78, 0.97]).
Slovenian: Po zdravljenju z disperzibilno tableto je bila izpostavljenost bosentanu nižja kot pri filmsko obloženi tableti (razmerje geometričnih sredin za AUC0-∞ 0,87
English: If you forget to take Tracleer
Slovenian: Če ste pozabili vzeti zdravilo Tracleer
English: Teratogenic effects, including malformations of the head and face and of the major vessels, were dose dependent.
Slovenian: kot so, malformacije glave, obraza in velikih žil, so bili odvisni od odmerka.
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.
Slovenian: Zato moramo v primeru, da se pri bolnikih s PAH, ko prejemajo zdravilo Tracleer, pojavijo znaki pljučnega edema, pomisliti na možnost sočasne venookluzivne bolezni.
English: 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.
Slovenian: Pri podganah je peroralno dajanje bosentana preko obdobja dveh let povzročilo majhno, a pomembno povečanje incidence adenomov in karcinomov ščitničnih folikularnih celic pri samcih, ne pa pri samicah, pri plazemskih koncentracijah, približno 9- do 14-krat višjih od plazemskih koncentracij, doseženih pri ljudeh po terapevtskih odmerkih.
English: Concomitant administration of both a CYP3A4 inhibitor and a CYP2C9 inhibitor with Tracleer should be avoided (see section 4.5).
Slovenian: Izogibati se moramo sočasni uporabi zaviralcev CYP3A4 in CYP2C9 z zdravilom Tracleer (glejte poglavje 4.5).
English: 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.
Slovenian: Opozorilna kartica za bolnika s pomembnimi varnostnimi informacijami, na katere mora biti bolnik pozoren pred in med zdravljenjem z zdravilom Tracleer, je priložena pakiranju zdravila.
English: 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.
Slovenian: V študiji FUTURE-4, ki je vključevala 13 novorojenčkov s PPHN, zdravljenih z bosentanom 2 mg/kg dvakrat dnevno manj kot 10 dni (razpon 0,5-10,0 dni), ni bilo primerov povišanja jetrnih aminotransferaz ≥ 3 × ULN med zdravljenjem, vendar pa je prišlo do enega primera hepatitisa 3 dni po prenehanju zdravljenja z bosentanom.
English: - 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.
Slovenian: - Pomožne snovi so mikrokristalna celuloza, brezvodni kalcijev hidrogenfosfat, premreženi natrijev karmelozat, koloidni brezvodni silicijev dioksid, vinska kislina, aroma sadja, aspartam (E951, preberite dodatne informacije na koncu poglavja 2), kalijev acesulfam, magnezijev stearat.
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)
Slovenian: • zvišani izsledki preiskav delovanja jeter s hepatitisom (vnetjem jeter), vključno z možnim poslabšanjem obstoječega hepatitisa in/ali zlatenica (porumenelost kože ali beločnice v očeh)
English: In the event of associated clinical symptoms of liver injury, i.e., nausea, vomiting, fever, abdominal pain, jaundice, unusual lethargy or fatigue, flu-like syndrome (arthralgia, myalgia, fever), treatment must be stopped and re-introduction of Tracleer is not to be considered.
Slovenian: V primeru kliničnih simptomov, povezanih z okvarjenim delovanjem jeter, npr. slabost, bruhanje, povišana telesna temperatura, bolečine v trebuhu, zlatenica, nenavadna letargija ali utrujenost, gripi podobni simptomi (bolečine v sklepih, bolečine v mišicah, povišana telesna temperatura), moramo zdravljenje prekiniti in ponovna uvedba zdravljenja z zdravilom Tracleer ni dovoljena.
English: There are no studies to demonstrate beneficial effects of Tracleer treatment on survival.
Slovenian: Raziskav, s katerimi bi pokazali koristne učinke zdravljenja z zdravilom Tracleer na preživetje bolnikov, ni.
English: Treatment with diuretics should be considered in patients with evidence of fluid retention before the start of treatment with Tracleer.
Slovenian: O zdravljenju z diuretiki razmislimo pri bolnikih z znaki zadrževanja tekočine že pred začetkom zdravljenja z zdravilom Tracleer.
English: After 4 weeks of bosentan 62.5 mg twice daily, the maintenance dose studied in both these studies was
Slovenian: Po 4 tednih jemanja bosentana v odmerku 62,5 mg dvakrat na dan so bili vzdrževalni odmerki, preučevani v teh študijah,
English: • other medications for the treatment of pulmonary hypertension: sildenafil and tadalafil;
Slovenian: • druga zdravila za zdravljenje pljučne hipertenzije: sildenafil in tadalafil, • varfarin (zdravilo za preprečevanje strjevanja krvi),
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.
Slovenian: Zdravljenje pri odraslih se običajno začne za 4 tedne z odmerkom 62,5 mg dvakrat na dan (zjutraj in zvečer), nakar vam bo vaš zdravnik glede na to, kakšen je vaš odziv na zdravilo Tracleer, verjetno svetoval, da začnete z jemanjem 125 mg tablet dvakrat na dan.
English: If it is possible that you could become pregnant, use a reliable form of birth control (contraception) while you are taking Tracleer.
Slovenian: Če je možno, da zanosite, uporabite zanesljivo obliko kontracepcije, medtem ko jemljete zdravilo
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.
Slovenian: Sistemska skleroza z nastajajočimi razjedami prstov Zdravljenje naj začne in vodi zdravnik z izkušnjami z zdravljenjem sistemske skleroze.
English: Palpitations1, 4
Slovenian: Pogosti palpitacije1, 4
English: The dispersible tablets should be added to a little water on a spoon, and the liquid stirred to aid dissolution, before swallowing.
Slovenian: Na žlico z vodo se da disperzibilna tableta, nato se tekočina meša za lažjo raztopitev, preden se pogoltne.
English: Therefore, you must not take Tracleer if you are pregnant and you must also not become pregnant while taking Tracleer.
Slovenian: Zato tega zdravila ne smete jemati, če ste noseči, v času, ko ga jemljete, pa tudi ne smete zanositi.
English: • 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).
Slovenian: Poročali so tudi o zamegljenem vidu, z neznano pogostnostjo (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
English: Be sure to discuss any questions you may have with your doctor or your gynaecologist - complete the details on the back of this card and take it to your doctor or gynaecologist at your next visit.
Slovenian: Izpolnite podatke na hrbtni strani te kartice in jo ob naslednjem obisku svojega zdravnika ali ginekologa vzemite s seboj.
English: Tracleer is contraindicated in patients with moderate to severe liver dysfunction (see sections 4.3, 4.4 and 5.2).
Slovenian: Zdravilo Tracleer je pri bolnikih s srednje in hudo okvarjenim delovanjem jeter kontraindicirano (glejte poglavja 4.3, 4.4 in 5.2).
English: Adverse reactions were defined as events occurring in at least 1% of patients on bosentan and at a frequency at least 0.5% more than on placebo.
Slovenian: Neželeni učinki so bili opredeljeni kot dogodki, ki so se pojavili pri vsaj 1 % bolnikov na bosentanu in z vsaj 0,5%
English: Separate the individual blister cavity at the perforations.
Slovenian: Posamične tablete v pretisnem omotu ločite po perforaciji.
English: Tel: +33 (0)1 55 00 26 66
Slovenian: Tél: +33 (0)1 55 00 26 66
English: 14 film-coated tablets 56 film-coated tablets 112 film-coated tablets
Slovenian: 14 filmsko obloženih tablet 56 filmsko obloženih tablet 112 filmsko obloženih tablet
English: Tracleer is contraindicated in pregnancy (see section 4.3).
Slovenian: Zdravilo Tracleer je kontraindicirano (glejte poglavje 4.3) med nosečnostjo.
English: Peel-push blisters containing 14 dispersible tablets; cartons contain 56 dispersible tablets.
Slovenian: Luščljiv pretisni omot s 14 disperzibilnimi tabletami: škatlice vsebujejo po 56 disperzibilnih tablet.
English: During treatment with Tracleer, your doctor will arrange for regular blood tests to check for changes in your liver function.
Slovenian: V času jemanja zdravila Tracleer bo zdravnik naročil redne preiskave krvi, da preveri, če je prišlo do sprememb v delovanju jeter.
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).
Slovenian: Pediatrična populacija Podatki pediatrične farmakokinetike so pokazali, da so bile povprečne koncentracije bosentana v plazmi pri otrocih s PAH, starih od 1 do 15 let, nižje kot pri odraslih bolnikih in da se z zvišanjem odmerka zdravila Tracleer nad 2 mg/kg telesne mase ali s povečanjem pogostnosti odmerjanja z dvakrat dnevno na trikrat dnevno niso zvečale (glejte poglavje 5.2).
English: Some patients taking Tracleer were found to have abnormal liver function tests.
Slovenian: Nekateri bolniki, ki so jemali zdravilo Tracleer, so imeli nenormalne rezultate preiskav delovanja jeter.
English: 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.
Slovenian: V študiji AC-052-356 (BREATHE-3) so ocenjevali farmakokinetiko enkratnega in večkratnih peroralnih odmerkov bosentana v obliki filmsko obloženih tablet pri 19 otrocih, starih od 3 do 15 let, s PAH, katerih odmerke so določili na podlagi telesne mase in so znašali 2 mg/kg dvakrat dnevno.
English: Your liver and blood values will be monitored during treatment with Tracleer (see section 2).
Slovenian: Med zdravljenjem z zdravilom Tracleer bodo spremljali vaše jetrne in krvne vrednosti (glejte poglavje 2).
English: Aspartame (E951), see the package leaflet for further information Aspartame (E951) may be harmful for people with phenylketonuria
Slovenian: Aspartam (E951) lahko škoduje ljudem s fenilketonurijo.
English: Concomitant use of rifampicin and Tracleer is not recommended.
Slovenian: Sočasna uporaba rifampicina in zdravila Tracleer ni priporočljiva.
English: Concomitant use of Tracleer and cyclosporine A is contraindicated (see sections 4.3 and 4.5).
Slovenian: Sočasna uporaba zdravila Tracleer in ciklosporina A je kontraindicirana (glejte poglavji 4.3 in 4.5).
English: Cyclosporine A: Co-administration of Tracleer and cyclosporine A (a calcineurin inhibitor) is contraindicated (see section 4.3).
Slovenian: Ciklosporin A: Sočasna uporaba zdravila Tracleer in ciklosporina A (kalcinevrinski zaviralec) je kontraindicirana (glejte poglavje 4.3).
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%).
Slovenian: Pri bolnikih, starih od 3 mesece do 1 leto (n = 2), je bila AUCτ 5.914 ng·h/ml (CV:85 %), pri bolnikih, starih od 1 do 2 leti (n = 7) pa 3.507·ng h/ml (CV: 70 %).
English: What Tracleer looks like and contents of the pack
Slovenian: Izgled zdravila Tracleer in vsebina pakiranja
English: 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.
Slovenian: V obdobju po uvedbi zdravila na trg so pri bolnikih, zdravljenih z zdravilom Tracleer, pri katerih so sumili na pljučno venookluzivno bolezen, o pljučnem edemu poročali redko.