FrancophonIA/ELRC3.0 huggingface dataset:
English: In this total population, Kaplan-Meier estimates of survival were 93% and 84% 1 and 2
Croatian: U toj populaciji Kaplan-Meier procjena preživljenja bila je 93% i 84% 1, odnosno 2
English: Some patients taking Tracleer were found to have abnormal liver function tests.
Croatian: Kod nekih bolesnika koji uzimaju Tracleer utvrđeni su abnormalni testovi funkcije jetre te anemija
English: Tests your doctor will do during treatment
Croatian: Nalazi koje će Vaš liječnik zatražiti prije liječenja
English: Appropriate precautions must be taken for women of childbearing potential (see sections 4.3, 4.4 and 4.6).
Croatian: U žena reproduktivne treba poduzeti odgovarajuće mjere opreza (vidjeti dijelove 4.3, 4.4 i 4.6).
English: How to take Tracleer
Croatian: Kako uzimati Tracleer
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).
Croatian: 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).
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).
Croatian: 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).
English: Tel: +33 (0)1 55 00 26 66
Croatian: Tél: +33 (0)1 55 00 26 66
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.
Croatian: 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.
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.
Croatian: U postmarketinškom razdoblju prijavljeni su rijetki slučajevi neobjašnjive ciroze jetre nakon produljene terapije s Tracleerom u bolesnika s višestrukim istodobnim pobolijevanjima i terapijama lijekovima.
English: • Flushed appearance or redness of skin
Croatian: • Pojava rumenila u licu ili crvenila na koži
English: Separate into halves by breaking the tablet along the break-marks (see figure below).
Croatian: Prelomite na pola duž linije (vidjeti sliku ispod).
English: Tracleer contains sodium
Croatian: Tracleer sadrži natrij
English: 2 Hypersensitivity reactions were reported in 9.9% of patients on bosentan and 9.1% of patients on placebo.
Croatian: 2 Reakcije preosjetljivosti prijavljene su u 9,9% bolesnika koji su dobivali bosentan i u 9,1% bolesnika koji su dobivali placebo.
English: If necessary, the dispersible tablet can be divided by breaking along the lines cut into the surface.
Croatian: Ako je potrebno, tableta za oralnu suspenziju može se razdijeliti lomljenjem duž crta urezanih na površini.
English: - The active substance is bosentan as monohydrate.
Croatian: - Djelatna tvar je bosentan u obliku bosentan hidrata.
English: 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).
Croatian: 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).
English: 5 Oedema or fluid retention was reported in 13.2% of patients on bosentan and 10.9% of patients on placebo.
Croatian: 5 Edem ili retencija tekućine prijavljeni su u 13,2% bolesnika koji su dobivali bosentan i 10,9% bolesnika koji su dobivali placebo.
English: • 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).
Croatian: • 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).
English: Peel off the top layer.
Croatian: Uklonite gornji sloj.
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.
Croatian: 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.
English: 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.
Croatian: 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.
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.
Croatian: 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.
English: 14 film-coated tablets 56 film-coated tablets 112 film-coated tablets
Croatian: 14 filmom obloženih tableta 56 filmom obloženih tableta 112 filmom obloženih tableta
English: Pale yellow to off-white, clover-shape tablets, quadrisected on one side and debossed with “32” on the other side.
Croatian: Blijedo žute do gotovo bijele tablete oblika djeteline, s razdjelnim urezima na četvrtine s jedne strane i s oznakom „32“ s druge strane.
English: 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.
Croatian: 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.
English: The film-coat contains hypromellose, glycerol triacetate, talc, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172) and ethylcellulose.
Croatian: Film ovojnica sadrži hipromelozu, glicerol triacetat, talk, titanijev diokisid (E171), željezov oksid žuti (E172), željezov oksid crveni (E172) i etilcelulozu.
English: 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.
Croatian: Povišenje jetrenih enzima dijelom može biti uzrokovano kompetetivnom inhibicijom eliminacije žučnih soli iz hepatocita, kao i drugim, još neutvrđenim mehanizmima poremećaja funkcije jetre.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON WITH 14, 56 AND 112 TABLETS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PAKIRANJE S 14, 56 I 112 TABLETA
English: Cartons contain 14, 56 or 112 film-coated tablets.
Croatian: Kutije sadrže 14, 56 ili 112 filmom obloženih tableta.
English: Do not store above 30 °C
Croatian: Ne čuvati na temperaturi iznad 30°C.
English: 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.
Croatian: U toj populaciji Kaplan-Meier procjena preživljenja bila je 93% i 84% 1, odnosno 2 godine od početka liječenja bosentanom.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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,
English: The dispersible tablets should be added to a little water on a spoon, and the liquid stirred to aid dissolution, before swallowing.
Croatian: Tablete za oralnu suspenziju prije gutanja treba dodati u malo vode na žlici i tekućinu promješati kako bi se pospješilo otapanje.
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.
Croatian: 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.
English: If the aminotransferase levels return to pre-treatment values continuing or reintroducing Tracleer according to the conditions described below should be considered.
Croatian: Ako se vrijednosti aminotransferaza vrate na vrijednosti prije liječenja, treba razmotriti nastavak ili ponovno liječenje Tracleerom u skladu s dolje navedenim uvjetima.
English: Concomitant use of rifampicin and Tracleer is not recommended.
Croatian: Istodobna primjena rifampicina i Tracleera nije preporučljiva.
English: 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.
Croatian: 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.
English: Aluminium/Aluminium peel-push blisters containing 14 dispersible tablets.
Croatian: Aluminij/aluminij blisteri koji sadrže 14 tableta za oralnu suspenziju.
English: Breast-feeding is not recommended during treatment with Tracleer.
Croatian: Dojenje se ne preporučuje tijekom liječenja
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON WITH 56 TABLETS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PAKIRANJE S 56 TABLETA
English: Patients in need of the combination should be closely monitored for adverse events related to Tracleer and for tacrolimus and sirolimus blood concentrations.
Croatian: Bolesnike kojima je potrebna kombinacija tih lijekova treba pažljivo nadzirati s obzirom na pojavu nuspojava vezanih za Tracleer te s obzirom na koncentracije takrolimusa ili sirolimusa u plazmi.
English: Tracleer 62.5 mg film-coated tablets PVC/PE/PVDC/aluminium-blisters containing 14 film-coated tablets.
Croatian: Tracleer 62,5 mg filmom obložene tablete PVC/PE/PVDC/aluminij blisteri koji sadrže 14 filmom obloženih tableta.
English: Cartons contain 14, 56 or
Croatian: Kutije sadrže 14, 56 ili 112
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.
Croatian: U pakiranje lijeka uključena je Kartica s upozorenjima za bolesnika koja sadrži važne sigurnosne informacije kojih bolesnici moraju biti svjesni prije i tijekom liječenja lijekom Tracleer.
English: If the aminotransferase levels return to pre-treatment values reintroducing Tracleer according to the conditions described below should be considered.
Croatian: Ako se vrijednosti aminotransferaza vrate na vrijednosti prije liječenja, treba razmotriti ponovno liječenje Tracleerom u skladu s dolje navedenim uvjetima.
English: However, some patients who show no response after 8 weeks of treatment with Tracleer may respond favourably after an additional 4 to 8 weeks of treatment.
Croatian: Tracleerom mogu pozitivno reagirati nakon dodatnih 4 do 8 tjedana liječenja.
English: Monthly pregnancy tests are recommended while you are taking Tracleer and are of childbearing age.
Croatian: preporučuju se mjesečni testovi na trudnoću tijekom uzimanja Tracleera.
English: Tracleer treatment should be initiated at a dose of 62.5 mg twice daily for 4 weeks and then increased to the maintenance dose of 125 mg twice daily.
Croatian: Liječenje Tracleerom treba započeti dozom od 62,5 mg dvaput dnevno u trajanju od 4 tjedna i potom povećati na dozu održavanja od 125 mg dvaput dnevno.
English: Twenty-six patients continued to receive bosentan in the 24-week open-label extension phase (AC-052-409) of the BREATHE-5 study (mean duration of treatment = 24.4 ± 2.0 weeks) and, in general, efficacy was maintained.
Croatian: 409) ispitivanja BREATHE-5 (srednje trajanje liječenja = 24,4 ± 2,0 tjedna) i općenito je djelotvornost bila održana.
English: Consequently, plasma concentrations of substances metabolised by these isoenzymes will be decreased when Tracleer is co-administered.
Croatian: Stoga su koncentracije tvari koje metaboliziraju ti izoenzimi kod istodobne primjene Tracleera smanjene u plazmi.
English: In patients between 3 months and 2 years the daily exposure was 7,879 ng·h/mL; AUCτ was 3,939 ng·h/mL (CV: 72%).
Croatian: mjeseca i 2 godine dnevna izloženost bila je 7879 ng•h/mL; AUCτ je bila 3939 ng•h/mL (CV: 72%).
English: In adult patients, Tracleer treatment should be initiated at a dose of 62.5 mg twice daily for 4 weeks and then increased to the maintenance dose of 125 mg twice daily.
Croatian: Kod odraslih bolesnika, liječenje Tracleerom treba započeti dozom od 62,5 mg dvaput dnevno u trajanju od 4 tjedna i potom povećati na dozu održavanja od 125 mg dvaput dnevno.
English: Dispersible tablet:
Croatian: Tableta za oralnu suspenziju:
English: A little more water should be added to the spoon and swallowed by the patient, to make sure all of the medicine has been administered.
Croatian: Bolesnik treba dodati još malo vode na žlicu i progutati je kako bi bio siguran da je uzeo sav lijek.
English: Tracleer 125 mg film-coated tablets PVC/PE/PVDC/aluminium-blisters containing 14 film-coated tablets.
Croatian: Tracleer 125 mg filmom obložene tablete PVC/PE/PVDC/aluminij blisteri koji sadrže 14 filmom obloženih tableta.
English: Hold the tablet between the thumb and the index finger on either side of the score line, with the score line facing upwards.
Croatian: Držite tabletu palcem i kažiprstom jedne ruke s jedne strane linije i palcem i kažiprstom druge ruke s druge strane linije okrenute prema gore.
English: The median bosentan and placebo treatment duration was, respectively, 4.5 days (range 0.5-10.0 days) and 4.0 days (range 2.5-6.5 days).
Croatian: 4,5 dana (raspon 0,5-10,0 dana), a placebom 4,0 dana (raspon 2,5-6,5 dana).
English: • if you are taking cyclosporine A (a medicine used after a transplant or to treat psoriasis) If any of these apply to you, tell your doctor.
Croatian: • ako uzimate ciklosporin A (lijek koji se koristi nakon transplantacije ili za liječenje psorijaze)
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Tracleer Lijek čuvajte izvan pogleda i dohvata djece.
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).
Croatian: Također je zabilježen i zamagljen vid s nepoznatom učestalošću (ne može se procijeniti iz dostupnih podataka).
English: In the patients above 2 years (n = 22) the daily exposure was 8,820 ng·h/mL; AUCτ was 4,410 ng·h/mL (CV: 58%).
Croatian: U bolesnika starijih od 2 godine (n = 22) dnevna izloženost bila je 8820 ng•h/mL; AUCτ je bila 4410 ng•h/mL
English: Patients were treated with bosentan 62.5 mg twice daily for 4 weeks followed by 125 mg twice daily for a further 12 weeks.
Croatian: Bolesnici su dobivali bosentan 62,5 mg dvaput dnevno tijekom 4 tjedna, a potom 125 mg dvaput dnevno tijekom daljnjih 12
English: Tracleer 32 mg dispersible tablets are pale yellow to off-white, clover-shape dispersible tablets, quadrisected on one side and debossed with “32” on the other side.
Croatian: Tableta za oralnu suspenziju Tracleer 32 mg je blijedo žute do gotovo bijele boje, oblika djeteline, s razdjelnim urezima na četvrtine s jedne strane i s oznakom „32“ s druge strane.
English: If necessary the dispersible tablet can be divided along the break-marks into four equal parts.
Croatian: Ako je potrebno, tableta za oralnu suspenziju može se, pomoću oznaka, razdijeliti na četiri jednaka dijela.
English: Skin and subcutaneous disorders Common
Croatian: Poremećaji kože i potkožnog tkiva Često
English: Peel-push blisters containing 14 dispersible tablets; cartons contain 56 dispersible tablets.
Croatian: Blisteri sadrže 14 tableta za oralnu suspenziju; pakiranja sadrže 56 tableta za oralnu suspenziju.
English: Bosentan is eliminated by biliary excretion following metabolism in the liver by the cytochrome P450 isoenzymes, CYP2C9 and CYP3A4.
Croatian: Bosentan se eliminira izlučivanjem putem žuči, nakog metaboliziranja putem citokrom P450 izoenzima CYP2C9 i CYP3A4 u jetri.
English: The dispersible tablet can be divided into four equal parts.
Croatian: Tableta za oralnu suspenziju može se radijeliti na četiri jednaka dijela.
English: A careful benefit/risk assessment should be made, taking into consideration that the liver toxicity is dose dependent (see sections 4.4 and 5.1).
Croatian: uzimajući u obzir da je toksično djelovanje na jetru ovisno o dozi (vidjeti dijelove 4.4 i 5.1).
English: • dark-coloured urine
Croatian: • tamno obojenu mokraću
English: Baseline (BL); mean (SD) Change from BL; mean (SD) Treatment effects 95% CL
Croatian: srednja vrijednost (SD) Promjena u odnosu na BL; srednja vrijednost (SD)
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.
Croatian: Takrolimus, sirolimus: istodobna primjena takrolimusa ili sirolimusa s Tracleerom nije ispitana u ljudi, ali istodobna primjena takrolimusa ili sirolimusa s Tracleerom kao i kod ciklosporina
English: A 2-year carcinogenicity study in mice showed an increased combined incidence of hepatocellular adenomas and carcinomas in males, but not in females, at plasma concentrations about 2 to 4 times the plasma concentrations achieved at the therapeutic dose in humans.
Croatian: Dvogodišnja studija kancerogenosti na miševima pokazala je povećanu kombiniranu učestalost hepatocelularnih adenoma i karcinoma u mužjaka, ali ne i ženki, kod koncentracija u plazmi koje su 2
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.
Croatian: 6.1 Popis pomoćnih tvari celuloza, mikrokristalična kalcijev hidrogenfosfat, bezvodni karmelozanatrij, umrežena silicijev dioksid, koloidni, bezvodni tartaratna kiselina tutti frutti okus aspartam (E951) acesulfamkalij magnezijev stearat
English: Cartons contain 56 film-coated tablets.
Croatian: Kutije sadrže 56 filmom obloženih tableta.
English: Treatment with Tracleer should only be started and monitored by a doctor who has experience in the treatment of PAH or systemic sclerosis.
Croatian: Liječenje treba započeti i nadzirati jedino liječnik s iskustvom u liječenju plućne arterijske hipertenzije ili sistemske skleroze.
English: For PVC/PE/PVDC/aluminium-blisters: Do not store above 30 °C.
Croatian: Za PVC/PE/PVDC/aluminij blistere:
English: Tracleer 62.5 mg film-coated tablets Each film-coated tablet contains 62.5 mg bosentan (as monohydrate).
Croatian: Tracleer 62,5 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 62,5 mg bosentana (u obliku bosentan hidrata).
English: In a randomised, double-blind, multi-centre, placebo-controlled study (AC-052-364 [EARLY]), 185 PAH patients in WHO functional class II (mean baseline 6-minute walk distance of 435 metres) received bosentan 62.5 mg twice daily for 4 weeks followed by 125 mg twice daily (n = 93), or placebo (n = 92) for 6 months.
Croatian: [EARLY]) 185 bolesnika s PAH-om WHO funkcionalnog stupnja II (srednja početna vrijednost udaljenosti prijeđene šestominutnim hodanjem od 435 metara) dobivali su bosentan 62,5 mg dvaput dnevno tijekom 4 tjedna, a potom 125 mg dvaput dnevno (n = 93) ili placebo (n = 92) tijekom 6
English: After 16 weeks' treatment, there were significant improvements from baseline in exercise capacity: the mean increase in 6-minute walk distance was 91.4 metres from 332.6 metres on average at baseline (p < 0.001).
Croatian: Nakon 16 tjedana liječenja došlo je do znatnog poboljšanja fizičke sposobnosti u odnosu na početnu vrijednost: srednje povećanje tijekom 6-minutne postignute udaljenosti hodom bilo je 91,4
English: Tracleer 125 mg film-coated tablets Each film-coated tablet contains 125 mg bosentan (as monohydrate).
Croatian: Tracleer 125 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 125 mg bosentana (u obliku bosentan hidrata).
English: Package leaflet: Information for the user Tracleer 62.5 mg film-coated tablets
Croatian: Uputa o lijeku: Informacije za korisnika Tracleer 62,5 mg filmom obložene tablete bosentan
English: In the AC-052-352 study, 92% of the 213 patients were classified at baseline as WHO functional class III and 8% as class IV.
Croatian: 92% od 213 bolesnika imalo je prije liječenja WHO funkcionalni stupanj III, a 8% stupanj IV.
English: - Tracleer 62.5 mg film-coated tablets: The active substance is bosentan as monohydrate.
Croatian: - Tracleer 62,5 mg filmom obložene tablete: Djelatna tvar je bosentan u obliku bosentan hidrata.
English: Rifampicin: Co-administration in 9 healthy subjects for 7 days of bosentan 125 mg twice daily with rifampicin, a potent inducer of CYP2C9 and CYP3A4, decreased the plasma concentrations of bosentan by 58%, and this decrease could achieve almost 90% in an individual case.
Croatian: Rifampicin: istodobna primjena u 9 zdravih osoba kroz 7 dana bosentana 125 mg dvaput dnevno s rifampicinom, jakim induktorom CYP2C9 i CYP3A4, smanjila je koncentracije bosentana u plazmi za
English: Concomitant use of Tracleer and cyclosporine A is contraindicated (see sections 4.3 and 4.5).
Croatian: Istodobna primjena s drugim lijekovima Kontraindicirana je istodobna primjena Tracleera s ciklosporinom A (vidjeti dio 4.3 i 4.5).
English: film-coated tablets (Tracleer 125 mg film-coated tablets).
Croatian: filmom obloženih tableta (Tracleer 125 mg filmom obložene tablete).
English: Package leaflet: Information for the user Tracleer 125 mg film-coated tablets
Croatian: Uputa o lijeku: Informacije za korisnika Tracleer 125 mg filmom obložene tablete bosentan