FrancophonIA/ELRC3.0 huggingface dataset:
English: In PAH and heart failure, in the absence of endothelin receptor antagonism, elevated ET-1 concentrations are strongly correlated with the severity and prognosis of these diseases.
Slovenian: Pri PAH in srčnem popuščanju, če ni antagonizma na endotelinskih receptorjih, so povišane koncentracije ET-1 močno povezane z resnostjo in prognozo teh bolezni.
English: Tracleer reduces the number of new finger and toe ulcers that appear.
Slovenian: Tracleer zmanjšuje število novih razjed prstov na rokah in nogah, ki se pojavijo.
English: Eisenmenger's physiology
Slovenian: Eisenmengerjevo fiziologijo.
English: Neither non-clinical nor clinical data are available to assess aspartame use in infants below 12 weeks of age.
Slovenian: Predkliničnih in kliničnih podatkov, s pomočjo katerih bi se ocenila uporaba aspartama pri dojenčkih, mlajših od 12 tednov, ni.
English: Tracleer should only be initiated if the systemic systolic blood pressure is higher than 85 mmHg.
Slovenian: Zdravljenje z zdravilom Tracleer lahko uvedemo le, če je sistolični krvni tlak višji od 85 mm Hg.
English: Each dispersible tablet contains 3.7 mg of aspartame (E951).
Slovenian: Ena disperzibilna tableta vsebuje 3,7 mg aspartama (E951).
English: This may be harmful for people with phenylketonuria.
Slovenian: To je lahko škodljivo za ljudi s fenilketonurijo.
English: Your doctor or gynaecologist will advise you about reliable contraceptive methods while taking Tracleer.
Slovenian: Vaš zdravnik ali ginekolog vam bo svetoval glede zanesljivih kontracepcijskih metod v času jemanja zdravila Tracleer.
English: What you need to know before you take Tracleer Do not take Tracleer:
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Tracleer Ne jemljite zdravila Tracleer:
English: The PAH for which Tracleer is indicated can be:
Slovenian: PAH, zaradi katere je zdravilo Tracleer predpisano, je lahko:
English: You are advised to stop breast-feeding if Tracleer is prescribed for you, because it is not known whether this medicine passes into breast milk.
Slovenian: Svetujemo vam, da prenehate dojiti, če ste dobili predpisano zdravilo Tracleer, saj ni znano, ali se to zdravilo izloča v mleko.
English: 125 mg twice daily.
Slovenian: 250 mg dvakrat na dan.
English: Please read the information under “Contraceptives” and “Other medicines and
Slovenian: Preberite informacije v poglavju „Kontraceptivi“ in „Druga zdravila in zdravilo Tracleer“,
English: Tracleer is used to treat:
Slovenian: Zdravilo Tracleer uporabljamo za zdravljenje:
English: Treatment must be stopped and re-introduction of Tracleer is not to be considered.
Slovenian: Zdravljenje moramo prekiniti in ponovna uvedba zdravljenja z zdravilom Tracleer ni dovoljena.
English: Tell your doctor immediately if you become pregnant while you are taking Tracleer, or plan to become pregnant in the near future.
Slovenian: Svojemu zdravniku takoj povejte, če v času jemanja zdravila Tracleer zanosite ali če načrtujete zanositev v bližnji prihodnosti.
English: Please note that Tracleer is also available as a dispersible 32 mg tablet formulation, which may make correct dosing easier for children and patients with low body weight or difficulties to swallow filmcoated tablets.
Slovenian: Zdravilo Tracleer je na voljo tudi v obliki disperzibilne 32-miligramske tablete, ki lahko olajša pravilno odmerjanje pri otrocih in bolnikih z nizko telesno maso ali težavami pri požiranju filmsko obloženih tablet.
English: What Tracleer is and what it is used for What you need to know before you take Tracleer How to take Tracleer
Slovenian: Kaj je zdravilo Tracleer in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Tracleer Kako jemati zdravilo Tracleer
English: What Tracleer is and what it is used for
Slovenian: Kaj je zdravilo Tracleer in za kaj ga uporabljamo
English: The side effects that have been reported in children treated with Tracleer are the same as those in adults.
Slovenian: Neželeni učinki, o katerih so poročali pri otrocih, zdravljenih z zdravilom Tracleer, so enaki kot pri odraslih.
English: For white high-density polyethylene bottles: This medicinal product does not require any special storage conditions.
Slovenian: Za bele plastenke iz polietilena visoke gostote: Za shranjevanje zdravila niso potrebna posebna navodila.
English: If you take more tablets than you have been told to take, contact your doctor immediately.
Slovenian: Če ste vzeli več tablet, kot vam je bilo naročeno, takoj pokličite zdravnika.
English: • Tracleer treatment must not be initiated in women of childbearing potential unless they practise reliable contraception and the result of the pre-treatment pregnancy test is negative
Slovenian: • se zdravilo Tracleer ne sme uvesti pri ženskah v rodni dobi, razen če uporabljajo zanesljivo kontracepcijo in je rezultat testa nosečnosti pred zdravljenjem negativen.
English: If necessary the dispersible tablet can be divided by breaking it along the lines cut into the surface (see section 6.6).
Slovenian: Po potrebi se lahko disperzibilna tableta prelomi po črtah, zarezanih v površino (glejte poglavje 6.6).
English: Suddenly stopping your treatment with Tracleer may lead to your symptoms getting worse.
Slovenian: Nenadna prekinitev zdravljenja z zdravilom Tracleer lahko povzroči, da bodo vaši simptomi postali bolj izraziti.
English: 43 (67.2%) were ≥ 2 years to 11 years old, 15 (23.4%) were between 1 and 2 years old, and 6 (9.4%) were between 3 months and 1 year old.
Slovenian: 43 otrok (67,2 %) je bilo starih od ≥ 2 leti do 11 let, 15 (23,4 %) je bilo starih od 1 do 2 leti, 6 (9,4 %) pa je bilo starih od 3 mesece do 1 leta.
English: The same recommendations apply to re-introduction of Tracleer after treatment interruption (see section 4.4).
Slovenian: Enaka priporočila veljajo ob ponovni uvedbi zdravila Tracleer po prekinitvi zdravljenja (glejte poglavje 4.4).
English: The remaining parts of a divided dispersible tablet can be stored at room temperature and should be used within 7 days.
Slovenian: Preostali deli razdeljene disperzibilne tablete se lahko hranijo pri sobni temperaturi in jih je treba porabiti v 7 dneh.
English: If you are a woman who could become pregnant, your doctor will ask you to take a pregnancy test before you start taking Tracleer, and regularly while you are taking Tracleer.
Slovenian: Če ste ženska, ki želi zanositi, vam bo zdravnik naročil, da opravite test nosečnosti, preden začnete jemati zdravilo Tracleer, nato pa redno v času jemanja zdravila Tracleer.
English: As Tracleer may render hormonal contraceptives ineffective, and taking into account the risk that pulmonary hypertension deteriorates with pregnancy as well as the teratogenic effects observed in animals:
Slovenian: Zdravilo Tracleer lahko povzroči neučinkovitost hormonske kontracepcije, in ob upoštevanju, da se tveganje za pljučno hipertenzijo z nosečnostjo poslabša, ter teratogenih učinkov, opaženih pri živalih:
English: Other medicines and Tracleer
Slovenian: Druga zdravila in zdravilo Tracleer
English: Tracleer can be taken with or without food.
Slovenian: Zdravilo Tracleer lahko jemljete s hrano ali brez nje.
English: If you are a man taking Tracleer, it is possible that this medicine may lower your sperm count.
Slovenian: Če ste moški in jemljete zdravilo Tracleer, je možno, da lahko to zdravilo zmanjša število semenčic.
English: For all these tests please refer also to the Patient Alert Card (inside your pack of Tracleer tablets).
Slovenian: Za te preiskave glejte tudi Opozorilno kartico za bolnika (v škatli s tabletami zdravila Tracleer).
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)
Slovenian: • izhodiščne vrednosti jetrnih aminotransferaz, tj. aspartat-aminotransferaze (AST) in/ali alanin aminotransferaze (ALT), več kot 3 × višje od zgornje meje normalnih vrednosti (ZMN, glejte poglavje 4.4)
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).
Slovenian: Primerjave biološke razpoložljivosti med disperzibilnimi tabletami in filmsko obloženimi tabletami, opravljena pri odraslih, je pokazala manjšo izpostavljenost bosentanu pri disperzibilnih tabletah (glejte poglavje 5.2).
English: Leave for about one minute, until the tablet has fully dissolved, and then swallow all of the liquid.
Slovenian: Počakajte približno eno minuto, da se tableta povsem raztopi, nato pa spijte z dovolj tekočine.
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.
Slovenian: Glavni namen opozorilne kartice za bolnika je bolnike poučiti o pomembnih varnostnih informacijah, s katerimi morajo biti seznanjeni pred in med zdravljenjem z zdravilom Tracleer.
English: Re-introduction of treatment with Tracleer should only be considered if the potential benefits of treatment with Tracleer outweigh the potential risks and when liver aminotransferase levels are within pre-treatment values.
Slovenian: Ponovna uvedba zdravljenja z zdravilom Tracleer pride v poštev le, če so potencialne koristi zdravljenja z zdravilom Tracleer večje kot potencialno tveganje in so ravni jetrnih aminotransferaz v okviru vrednosti pred zdravljenjem.
English: Each Tracleer dispersible tablet can be dissolved in water to make a liquid medicine.
Slovenian: Vsako disperzibilno tableto zdravila Tracleer lahko raztopite v vodi, da nastane tekoče zdravilo.
English: If these results are abnormal, your doctor may decide to reduce your dose or stop treatment with Tracleer and to perform further tests to investigate the cause.
Slovenian: Če bodo rezultati preiskav nenormalni, se bo vaš zdravnik lahko odločil za znižanje vašega odmerka ali prekinitev zdravljenja z zdravilom Tracleer ter opravil dodatne preiskave, da bi odkril vzrok za nenormalne rezultate.
English: Tracleer may harm unborn babies conceived before starting or during treatment.
Slovenian: Zdravilo Tracleer lahko škoduje nerojenemu otroku, spočetemu pred začetkom zdravljenja ali med njim.
English: The requirements for submission of periodic safety update reports including liver reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
English: For children aged 1 year and older, treatment with Tracleer is usually started with 2 mg per kg bodyweight twice daily (morning and evening).
Slovenian: Za otroke, stare 1 leto in več, se zdravljenje z zdravilom Tracleer običajno začne z 2 mg na kg telesne mase dvakrat dnevno (zjutraj in zvečer).
English: Tracleer widens the pulmonary arteries, making it easier for the heart to pump blood through them.
Slovenian: Zdravilo Tracleer razširi pljučne arterije in olajša srcu črpanje krvi skozi te žile.
English: Clinical experience with concomitant administration of bosentan with warfarin in patients with PAH did not result in clinically relevant changes in International Normalized Ratio (INR) or warfarin dose (baseline versus end of the clinical studies).
Slovenian: Klinične izkušnje s sočasno uporabo bosentana in varfarina pri bolnikih s PAH niso pokazale klinično pomembnih sprememb v mednarodnem normaliziranem razmerju (INR - International Normalized Ratio) ali odmerku varfarina (izhodiščna vrednost v primerjavi z vrednostjo na koncu kliničnih študij).
English: Patients in need of the combination should be closely monitored for adverse events related to Tracleer and for tacrolimus and sirolimus blood concentrations.
Slovenian: Bolnike, ki to kombinacijo potrebujejo, je treba pazljivo opazovati glede neželenih dogodkov, povezanih z zdravilom Tracleer, in spremljati koncentracije takrolimusa in sirolimusa v krvi.
English: You should have a pregnancy test before initiation of Tracleer and every month during the treatment even if you think that you are not pregnant.
Slovenian: Pred začetkom zdravljenja z zdravilom Tracleer in vsak mesec med zdravljenjem opravite test nosečnosti, tudi če menite, da niste noseči.
English: Tracleer 32 mg dispersible tablets contain a source of phenylalanine (Aspartame - E951).
Slovenian: Zdravilo Tracleer 32 mg disperzibilne tablete vsebujejo vir fenilalanina (aspartam - E951).
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.
Slovenian: Nekateri bolniki, ki se ne odzovejo dobro pri odmerku 125 mg zdravila Tracleer dvakrat na dan, bi lahko nekoliko izboljšali svojo fizično zmogljivost, če odmerek povišamo na 250 mg dvakrat na dan.
English: Dispersible tablet:
Slovenian: Disperzibilna tableta:
English: No specific studies have been conducted to assess the direct effect of Tracleer on the ability to drive and use machines.
Slovenian: Specifičnih študij za ocenitev neposrednega učinka zdravila Tracleer na sposobnost vožnje in upravljanja strojev niso izvedli.
English: Contents of the pack and other information What Tracleer contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Tracleer
English: Hold the tablet between the thumb and index finger on either side of one of the lines, with the line facing upwards, and break the tablet along the line (see figure below).
Slovenian: Tableto držite s palcema in kazalcema na vsaki strani črte, ki naj gledajo navzgor, in tableto prelomite po črti (glejte spodnji prikaz).
English: Your doctor and/or gynaecologist will establish the contraception which is appropriate for you.
Slovenian: Vaš zdravnik in/ali ginekolog bo ugotovil, katera kontracepcija je za vas najprimernejša.
English: Tracleer contains aspartame and sodium
Slovenian: Zdravilo Tracleer vsebuje aspartam in natrij
English: Тел.
Slovenian: Teл.
English: Because of possible hormonal contraception failure during Tracleer treatment, and also bearing in mind the risk that pulmonary hypertension severely deteriorates with pregnancy, monthly pregnancy tests during treatment with Tracleer are recommended to allow early detection of pregnancy.
Slovenian: Zaradi možne odpovedi hormonske kontracepcije v času zdravljenja z zdravilom Tracleer in ob upoštevanju tveganja, da se pljučna hipertenzija z nosečnostjo hudo poslabša, se v času zdravljenja z zdravilom Tracleer priporočajo mesečni testi nosečnosti za zgodnje odkrivanje nosečnosti.
English: In the post-marketing period there was one reported overdose of 10,000 mg of Tracleer taken by an adolescent male patient.
Slovenian: V obdobju po začetku trženja so poročali o enem primeru prevelikega odmerjanja zdravila Tracleer (10.000 mg) pri mladoletnem moškem.
English: 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).
Slovenian: Povišane vrednosti aminotransferaz se lahko spontano znižajo z nadaljevanjem zdravljenja z vzdrževalnim odmerkom zdravila Tracleer ali po znižanju odmerka, vendar je možno, da bo treba zdravljenje prekiniti ali z njim prenehati (glejte poglavje 4.4).
English: Therefore, if you feel dizzy or that your vision is blurred while taking Tracleer, do not drive or operate any tools or machines.
Slovenian: Če ste v času jemanja zdravila Tracleer omotični ali imate zamegljen vid, ne vozite in ne upravljajte nobenega orodja ali strojev.
English: Do not stop taking Tracleer unless your doctor tells you to.
Slovenian: Zdravilo Tracleer jemljite, dokler vam vaš zdravnik ne reče, da ga nehajte jemati.
English: If the decision to withdraw Tracleer is taken, it should be done gradually while an alternative therapy is introduced.
Slovenian: Če se odločite za prenehanje jemanja zdravila Tracleer, je treba to izvesti postopoma, medtem ko sočasno uvajate drugo zdravljenje.
English: Tracleer therefore causes blood vessels to expand and belongs to the class of medicines called “endothelin receptor antagonists”.
Slovenian: Zdravilo Tracleer tako povzroči razširitev krvnih žil in sodi v skupino zdravil imenovanih „antagonisti endotelinskih receptorjev“.
English: These will be done every month for the duration of treatment with Tracleer.
Slovenian: Opravijo se vsak mesec v času zdravljenja z zdravilom Tracleer.
English: 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.
Slovenian: Takrolimus, sirolimus: Sočasne uporabe zdravila Tracleer s takrolimusom in sirolimusom pri človeku sicer niso preučili, lahko pa sočasno dajanje takrolimusa ali sirolimusa z zdravilom Tracleer povzroči povišane plazemske koncentracije bosentana po analogiji sočasnega dajanja ciklosporina A. Sočasno dajanje zdravila Tracleer lahko zniža plazemske koncentracije takrolimusa in sirolimusa.
English: • lethargy or fatigue (unusual tiredness or exhaustion)
Slovenian: • letargijo ali utrujenost (nenavadna utrujenost ali izčrpanost)
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).
Slovenian: V študiji AC-052-391 (FUTURE 4), ki so jo izvedli pri novorojenčkih, so koncentracije bosentana v prvem intervalu odmerjanja počasi in stalno naraščale, kar je imelo za posledico nizko izpostavljenost (AUC0-12 v celi krvi: 164 ng·h/ml, n = 11).
English: • Anaphylaxis (general allergic reaction), angioedema (swelling, most commonly around the eyes, lips, tongue or throat)
Slovenian: • anafilaksa (splošna alergijska reakcija), angioedem (oteklost, običajno okoli oči, ustnic, jezika ali grla)
English: • Hormonal contraceptives cannot be the sole method of contraception during treatment with Tracleer
Slovenian: • hormonski kontraceptivi ne smejo biti edini način kontracepcije med zdravljenjem z zdravilom
English: • other medicines for the treatment of HIV infection, which may require special monitoring if used together with Tracleer.
Slovenian: • druga zdravila za zdravljenje okužb s HIV, zaradi katerih je potrebno pri uporabi skupaj z zdravilom Tracleer skrbno spremljanje,
English: Concomitant use of Tracleer with glibenclamide, fluconazole and rifampicin is not recommended.
Slovenian: Sočasna uporaba zdravila Tracleer z glibenklamidom, flukonazolom in rifampicinom se ne priporoča.
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.
Slovenian: V farmakokinetični navzkrižni študiji (AC-052-116) je 16 zdravih odraslih oseb prejelo 62,5 mg bosentana v obliki formulacije z 62,5 mg filmsko obloženo tableto ali 64 mg bosentana v obliki formulacije z 32 mg disperzibilno tableto.
English: The similarities of the pattern of malformations observed with other ET receptor antagonists and in ET knock-out mice indicate a class effect.
Slovenian: Podobnosti v vzorcu malformacij, ki so jih opazili pri drugih antagonistih receptorjev ET in pri ET „knock-out“ miših, kažejo, da gre za učinek skupine zdravil.
English: Bosentan competes with the binding of ET-1 and other ET peptides to both ETA and ETB receptors, with a slightly higher affinity for ETA receptors (Ki = 4.1-43 nanomolar) than for ETB receptors (Ki = 38-730 nanomolar).
Slovenian: Bosentan tekmuje z vezavo ET-1 in drugih peptidov ET na receptorje ETA in ETB, z malo večjo afiniteto za receptorje ETA (Ki = 4,1-43 nanomolarna)) kot za receptorje ETB (Ki = 38-730
English: If you take more Tracleer than you should
Slovenian: Če ste vzeli večji odmerek zdravila Tracleer, kot bi smeli
English: • Flushed appearance or redness of skin
Slovenian: • videz pordelosti ali rdečina kože
English: 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.
Slovenian: V obdobju trženja so poročali o redkih primerih nerazložene jetrne ciroze po dolgotrajnem zdravljenju z zdravilom Tracleer pri bolnikih s številnimi drugimi sočasnimi boleznimi in zdravljenji z zdravili.
English: He had symptoms of nausea, vomiting, hypotension, dizziness, sweating and blurred vision.
Slovenian: Imel je simptome navzee, bruhanja, hipotenzije, omotičnosti, potenja in zamegljenega vida.
English: • Pulmonary arterial hypertension associated with congenital systemic-to-pulmonary shunts and
Slovenian: • pljučni arterijski hipertenziji, povezani s kongenitalnimi sistemsko-pulmonalnimi šanti in
English: Tracleer 125 mg film-coated tablets EU/1/02/220/004
Slovenian: Tracleer 125 mg filmsko obložene tablete EU/1/02/220/004
English: Liver aminotransferase levels must be measured prior to initiation of treatment and subsequently at monthly intervals for the duration of treatment with Tracleer.
Slovenian: Ravni jetrnih aminotransferaz moramo izmeriti pred začetkom zdravljenja in nato redno enkrat na mesec ves čas zdravljenja z zdravilom Tracleer.
English: No dose adjustment of Tracleer is considered necessary.
Slovenian: Prilagoditev odmerka zdravila Tracleer ni potrebna.
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.
Slovenian: • glibenklamid (za zdravljenje sladkorne bolezni), rifampicin (za zdravljenje tuberkuloze), flukonazol, (za zdravljenje glivičnih okužb), ketokonazol (za zdravljenje Cushingovega sindroma) ali nevirapin (za zdravljenje okužbe s HIV), saj se uporaba teh zdravil skupaj z zdravilom Tracleer ne priporoča,
English: However, Tracleer may induce hypotension, with symptoms of dizziness, blurred vision or syncope that could affect the ability to drive or use machines.
Slovenian: Zdravilo Tracleer lahko povzroči hipotenzijo s simptomi omotice, zamegljenega vida ali sinkope, ki bi lahko vplivala na sposobnost vožnje in upravljanja strojev.
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.
Slovenian: Ko se zdravljenje z zdravilom Tracleer uvede pri bolnikih, ki potrebujejo zaviralce proteaze, pospešene z ritonavirjem, je treba prenašanje zdravila Tracleer pri teh bolnikih skrbno nadzirati s posebno pozornostjo na začetku faze uvajanja v zvezi s tveganjem hipotenzije in preiskavami delovanja jeter.
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)
Slovenian: • preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 • srednje do hudo okvarjeno delovanje jeter, tj. razred B ali C po Child-Pughu (glejte poglavje
English: Treatment with Tracleer should only be started and monitored by a doctor who has experience in the treatment of PAH or systemic sclerosis.
Slovenian: Zdravljenje z zdravilom Tracleer mora uvesti in nadzirati zdravnik z izkušnjami v zdravljenju PAH ali sistemske skleroze.