FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, you must not take STAYVEER if you are pregnant and you must also not become pregnant while taking STAYVEER.
Croatian: Zbog toga ne smijete uzimati STAYVEER ako ste trudni te ne smijete zatrudnjeti tijekom uzimanja STAYVEERA.
English: However, when combined with a CYP3A4 inhibitor, patients who are poor metabolisers of CYP2C9 are at risk of increases in bosentan plasma concentrations that may be of higher magnitude, thus leading to potential harmful adverse events.
Croatian: Međutim, kada se kombinira sa inhibitorima CYP3A4, u bolesnika sa smanjenim djelovanjem CYP2C9 postoji rizik od većih povećanja koncentracije bosentana u plazmi, koja mogu uzrokovati štetne događaje.
English: • At the request of the European Medicines Agency.
Croatian: Ažurirani RMP treba dostaviti: • na zahtjev Europske agencije za lijekove
English: In the adult placebo-controlled studies, a decrease in haemoglobin concentration to below 10 g/dL from baseline was reported in 8.0% of bosentan-treated patients and 3.9% of placebo-treated patients (see section 4.4).
Croatian: U placebom kontroliranim studijama na odraslima, smanjenje koncentracije hemoglobina ispod 10 g/dl od početne vrijednosti prijavljeno je kod 8,0% bolesnika koji su dobivali bosentan i 3,9% bolesnika koji su dobivali placebo (vidjeti dio 4.4).
English: STAYVEER has not been shown to have a beneficial effect on the healing of existing digital ulcers.
Croatian: Za STAYVEER nije pokazano da je učinkovit u zacjeljivanju postojećih ulceracija prstiju.
English: In study AC-052-331, during 24 weeks of double-blind therapy, the corresponding figures were 1.9 vs 2.7 new digital ulcers, respectively (p = 0.0351).
Croatian: U studiji AC-052-331 tijekom 24 tjedna dvostruko slijepe terapije pojavilo se 1,9, odnosno 2,7 novih ulceracija prstiju (p = 0,0351).
English: Dosing bosentan 2 mg/kg three times daily did not increase exposure; daily exposure was 7,275 ng·h/mL (CV: 83%, n = 27).
Croatian: Doziranje bosentana od 2 mg/kg triput dnevno nije povećalo izloženost; dnevna izloženost bila je 7275 ng•h/mL (CV: 83%, n = 27).
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 STAYVEER.
Croatian: Općeniti je cilj Kartice s upozorenjima za bolesnika upoznati bolesnike s važnim sigurnosnim informacijama kojih moraju biti svjesni prije i tijekom liječenja lijekom STAYVEER.
English: In a retrospective responder analysis based on change in walking distance, WHO functional class and dyspnoea of the 95 patients randomised to bosentan 125 mg twice daily in the placebo-controlled studies, it was found that at week 8, 66 patients had improved, 22 were stable and 7 had deteriorated.
Croatian: funkcionalnog stupnja i dispneje, na 95 bolesnika koji su dobivali bosentan 125 mg dvaput dnevno u randomiziranoj, placebom kontroliranoj studiji, pronađeno je da je nakon 8 tjedana u 66 bolesnika stanje bilo poboljšano, u 22 stabilno, a u 7 pogoršano.
English: Upon multiple dosing, plasma concentrations of bosentan decrease gradually to 50-65% of those seen after single dose administration.
Croatian: Nakon višestrukog doziranja, koncentracije bosentana u plazmi postupno se smanjuju do 50-65%
English: After an increase in dose, an additional test will be done after 2 weeks.
Croatian: Nakon povećanja doze trebat će napraviti nove pretrage nakon 2 tjedna.
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: Medijan trajanja liječenja bosentanom bio je 4,5 dana (raspon 0,5-10,0 dana), a placebom 4,0 dana (raspon 2,5-6,5 dana).
English: The majority of patients were diagnosed as primary pulmonary hypertension (72%) and were in WHO functional class III (84%).
Croatian: Većina bolesnika imala je dijagnozu primarne plućne hipertenzije (72%) te su bili u skupini III prema WHO
English: • Digital ulcers: (sores on the fingers and toes) in adult patients with a condition called scleroderma.
Croatian: • ulceracija na prstima (rane na prstima ruku i nogu) koje se javljaju kod odraslih oboljelih od sklerodermije.
English: The mean AUC (CV%) values of bosentan in paediatric patients treated with 31.25, 62.5 or 125 mg twice daily were 3,496 (49), 5,428 (79), and 6,124 (27) ng·h/mL, respectively, and were lower than the value of 8,149 (47) ng·h/mL observed in adult patients with PAH receiving 125 mg twice daily.
Croatian: Srednje AUC (CV%) vrijednosti bosentana u pedijatrijskih bolesnika koji su dobivali 31,25, 62,5 ili 125 mg dvaput dnevno bile su 3496 (49), 5428 (79), odnosno 6124 (27) ng•h/ml te su bile niže od vrijednosti 8149 (47) ng•h/ml uočene kod odraslih bolesnika s PAH-om koji su dobivali 125 mg dvaput dnevno.
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, smanjila je AUC noretisterona i etinilestradiola za 14%, odnosno 31%.
English: The effect of bosentan on mitochondrial function is unknown.
Croatian: Nije poznat utjecaj bosentana na funkciju mitohondrija.
English: Concomitant administration of both a CYP3A4 inhibitor and a CYP2C9 inhibitor with STAYVEER should be avoided (see section 4.5).
Croatian: Treba izbjegavati istodobnu primjenu inhibitora CYP3A4 i CYP2C9 sa STAYVEEROM (vidjeti dio 4.5).
English: Should this occur, starting treatment with diuretics is recommended, or the dose of existing diuretics should be increased.
Croatian: Pojave li se znakovi zadržavanja tekućine, preporučuje se započeti liječenje diureticima ili povećati dozu diuretika koje bolesnici već uzimaju.
English: Rare (may affect up to one in 1000 people):
Croatian: Rijetke (mogu se pojaviti u do 1 na 1000 osoba):
English: In study AC-052-331, patients had to have at least one digital ulcer of recent onset, and across the two studies 85% of patients had ongoing digital ulcer disease at baseline.
Croatian: U studiji AC-052-331 bolesnici su imali barem jednu nedavnu pojavu ulceracije prstiju, a u dvije studije zajedno 85% bolesnika imalo je ulceraciju prstiju na početku.
English: PATIENT ALERT CARD
Croatian: KARTICA S UPOZORENJIMA ZA BOLESNIKA
English: • sirolimus or tacrolimus, which are medicines used after transplants, as these are not recommended to be used together with STAYVEER.
Croatian: • sirolimus ili takrolimus, lijekovi koji se uzimaju nakon transplantacije, budući da nije preporučljivo uzimati ih zajedno sa STAYVEEROM
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: U studiji AC-052352, 92% od 213 bolesnika imalo je prije liječenja WHO funkcionalni stupanj III, a 8% stupnaj IV.
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: U 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: 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: Based on the findings in studies BREATHE-3, FUTURE 1, and FUTURE-3, it appears that the exposure to bosentan reaches a plateau at lower doses in paediatric patients than in adults, and that doses higher than 2 mg/kg twice daily (4 mg/kg twice daily or 2 mg/kg three times daily) will not result in greater exposure to bosentan in paediatric patients.
Croatian: Na osnovi nalaza u studijama BREATHE-3, FUTURE 1 i FUTURE-3 pokazalo se da izloženost bosentanu doseže plato kod nižih doza u pedijatrijskih bolesnika nego u odraslih te da doze više od 2 mg/kg dvaput dnevno (4 mg/kg dvaput dnevno ili 2 mg/kg triput dnevno) neće rezultirati povećanom izloženosti bosentanu kod pedijatrijskih bolesnika.
English: Changes in exercise test parameters at week 12 from baseline were highly variable and none were significant.
Croatian: Promjene u testu fizičkog opterećenja nakon 12 tjedana bile su jako varijabilne te nisu bile statistički značajne.
English: If the aminotransferase levels return to pre-treatment values reintroducing STAYVEER according to the conditions described below should be considered.
Croatian: Ako se vrijednosti aminotransferaza vrate na vrijednosti prije liječenja, treba razmotriti ponovno liječenje STAYVEEROM u skladu s dolje navedenim uvjetima.
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 11 godina.
English: Remember to have your liver blood test every month.
Croatian: Sjetite se svaki mjesec napraviti nalaze funkcije jetre.
English: In study AC-052-373 (FUTURE 3), using dispersible tablets, the exposure to bosentan in the patients treated with 2 mg/kg twice daily was comparable to that in the FUTURE 1 study.
Croatian: U studiji AC-052-373 (FUTURE 3) uz primjenu tableta za oralnu suspenziju, izloženost bolesnika liječenih s 2 mg/kg bosentana dvaput dnevno bila je usporediva onoj u studiji FUTURE 1.
English: There is limited experience with abrupt discontinuation of STAYVEER in patients with PAH.
Croatian: Postoji ograničeno iskustvo s naglim prekidom primjene STAYVEERA u bolesnika s PAH-om.
English: Treatment effects
Croatian: Učinci liječenja
English: The efficacy of STAYVEER has not been established in patients with severe PAH.
Croatian: Djelotvornost STAYVEERA nije utvrđena u bolesnika s teškim PAH-om.
English: In addition, an increased incidence of elevated aminotransferases was observed in patients receiving concomitant therapy.
Croatian: Primijećena je i povećana učestalost povišenih vrijednosti aminotransferaza u bolesnika koji su istodobno dobivali ta dva lijeka.
English: Tadalafil: Bosentan (125 mg twice daily) reduced tadalafil (40 mg once per day) systemic exposure by 42% and Cmax by 27% following multiple dose co-administration.
Croatian: Tadalafil: bosentan (125 mg dva puta dnevno) smanjio je sistemsko izlaganje tadalafila (40 mg jednom na dan) za 42% te vrijednost Cmax za 27% nakon istodobne primjene višestruke doze.
English: Lopinavir+ritonavir (and other ritonavir-boosted protease inhibitors): Co-administration of bosentan 125 mg twice daily and lopinavir+ritonavir 400+100 mg twice daily for 9.5 days in healthy volunteers resulted in initial trough plasma concentrations of bosentan that were approximately 48-fold higher than those measured after bosentan administered alone.
Croatian: Lopinavir + ritonavir (i drugi ritonavirom pojačani inhibitori proteaze): istodobna primjena bosentana 125 mg dvaput dnevno i lopinavira 400 mg + ritonavira 100 mg dvaput dnevno kroz 9,5 dana kod zdravih dobrovoljaca rezultirala je početnim najnižim koncentracijama bosentana u plazmi koje su bile približno 48 puta više od onih izmjerenih nakon primjene bosentana samostalno.
English: White high-density polyethylene bottles with a silica gel desiccant containing 56 film-coated tablets.
Croatian: Bijele boce od polietilena visoke gustoće sa sredstvom za sušenje od silika gela sadrže 56 filmom obloženih tableta.
English: AC-052-355 was a multi-centre, randomised, double-blind, parallel-group study of bosentan versus placebo in 33 patients with severe PAH who were receiving concomitant epoprostenol therapy.
Croatian: AC-052-355 bila je multicentrična, randomizirana, dvostruko slijepa, s paralelnim grupama, studija bosentana u odnosu na placebo na 33 bolesnika s teškim PAH-om koji su istodobno dobivali epoprostenol.
English: ((Back cover))
Croatian: ((Stražnja stranica))
English: Treatment with diuretics should be considered in patients with evidence of fluid retention before the start of treatment with STAYVEER.
Croatian: Liječenje diureticima treba uzeti u obzir u bolesnika u kojih je već prisutno zadržavanje tekućine prije početka liječenja STAYVEEROM.
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: U 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: 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 nekontrolianog produžetka studije FUTURE 2 i za njih je medijan sveukupnog trajanja liječenja iznosio 2,3 godine (raspon 0,2 do 5,0 godina).
English: Elevations to ≥ 8 × ULN were seen in 3.6% of the bosentan-treated patients and 0.4% of the placebo-treated patients.
Croatian: Povećanja za ≥ 8 × GGN viđena su u 3,6% bolesnika koji su dobivali bosentan i 0,4% bolesnika koji su dobivali placebo.
English: These elevations in aminotransferases may reverse spontaneously while continuing treatment with the maintenance dose of STAYVEER 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: At study entry, patients were treated with PAH medications (most frequently phosphodiesterase type-5 inhibitor [sildenafil] alone [35.9%], bosentan alone [10.9%], and a combination of bosentan, iloprost, and sildenafil [10.9%]) and continued their PAH treatment during the study.
Croatian: 5 [sildenafil] u monoterapiji [35,9%], bosentanom u monoterapiji [10,9%] i kombinacijom bosentana, iloprosta i sildenafila [10,9%]) i nastavili su svoje liječenje za PAH tijekom studije.
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.
Croatian: U štakora je oralna primjena bosentana tijekom 2 godine dovela do malog, ali značajnog povećanja kombinirane učestalosti adenoma i karcinoma folikularnih stanica štitnjače u mužjaka, ali ne i ženki, kod koncentracija u plazmi koje su 9 do 14 puta veće od onih koje se postižu kod terapijskih doza u ljudi.
English: Hypotension1, 4
Croatian: Hipotenzija1,4
English: It was primarily designed as a pharmacokinetic study (see section 5.2).
Croatian: Bila je zamišljena prvenstveno kao farmakokinetička studija (vidjeti dio 5.2).
English: This study was primarily designed as a pharmacokinetic study (see section 5.2).
Croatian: Ta studija zamišljena je prvenstveno kao farmakokinetička studija (vidjeti dio 5.2).
English: The combination of bosentan and epoprostenol has been investigated in two studies: AC-052-355 (BREATHE-2) and AC-052-356 (BREATHE-3).
Croatian: Kombinacija s epoprostenolom Kombinacija bosentana i epoprostenola ispitana je u sklopu dvije studije: AC-052-355 (BREATHE-2)
English: Bosentan is an inducer of CYP2C9 and CYP3A4 and possibly also of CYP2C19 and the P-glycoprotein.
Croatian: Bosentan inducira CYP2C9 i CYP3A4, a vjerojatno i CYP2C19, kao i p-glikoprotein.
English: Cases of pulmonary oedema have been reported with vasodilators (mainly prostacyclins) when used in patients with pulmonary veno-occlusive disease.
Croatian: Slučajevi plućnog edema zabilježeni su kod primjene vazodilatatora (uglavnom prostaciklina) u bolesnika s okluzivnom bolesti plućnih vena.
English: In the FUTURE-4 study, 6 out of 13 bosentan-treated neonates with PPHN experienced a decrease in haemoglobin from within the reference range at baseline to below the lower limit of normal during the treatment.
Croatian: U studiji FUTURE-4, u 6 od 13 novorođenčadi s PPHN-om liječene bosentanom došlo je do smanjenja razine hemoglobina s normalne razine na početku liječenja na razinu ispod donje razine referentnih vrijednosti tijekom liječenja.
English: Based on physicochemical properties and the high degree of protein binding, bosentan is not expected to be removed from the circulation by dialysis to any significant extent (see section 4.2).
Croatian: Na osnovi fizičko-kemijskih svojstava i visokog stupnja vezanja za proteine, za bosentan se ne očekuje da se može ukloniti iz krvi dijalizom u značajnijoj mjeri
English: In addition, the frequency of changes in warfarin dose during the studies due to changes in INR or due to adverse events was similar among bosentan- and placebo-treated patients.
Croatian: Učestalost promjena doze varfarina tijekom studija uslijed promjena INR-a ili nuspojava bila je slična među bolesnicima koji su dobivali bosentan, odnosno placebo.
English: STAYVEER reduces the number of new finger and toe ulcers that appear.
Croatian: STAYVEER smanjuje pojavljivanje novih ulceracija na prstima ruku i nogu.
English: In vitro data demonstrated that bosentan had no relevant inhibitory effect on the CYP isoenzymes tested (CYP1A2, 2A6, 2B6, 2C8, 2C9, 2D6, 2E1, 3A4).
Croatian: izoenzime (CYP1A2, 2A6, 2B6, 2C8, 2C9, 2D6, 2E1, 3A4).
English: Breast-feeding is not recommended during treatment with STAYVEER.
Croatian: Dojenje se ne preporučuje tijekom liječenja
English: The dosage of these products may need to be adjusted after initiation, dose change or discontinuation of concomitant STAYVEER treatment.
Croatian: Doziranje tih lijekova treba prilagoditi nakon početka istodobnog liječenja STAYVEEROM, kod promjene doze ili kod prekida istodobnog liječenja STAYVEEROM.
English: What you need to know before you take STAYVEER Do not take STAYVEER:
Croatian: Što morate znati prije nego počnete uzimati STAYVEER
English: The placebo-corrected increases in walk distance compared with baseline were 76 metres (p = 0.02; t-test) and 44 metres (p = 0.0002; Mann-Whitney U test) at the primary endpoint of each study, respectively.
Croatian: t-test), odnosno 44 metra (p = 0,0002, Mann-Whitney U-test) u primarnom ishodu svake studije.
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 da li Vam je potrebna dodatna ili drugačija pouzdana metoda kontracepcije.
English: The table below illustrates the pre-specified protocol analyses.
Croatian: Donja tablica prikazuje provedene analize.
English: Limited data in patients show that the exposure to bosentan in adult PAH patients is approximately 2-fold greater than in healthy adult subjects.
Croatian: Ograničeni podaci za odrasle bolesnike s PAH-om pokazuju približno 2 puta veću izloženost bosentanu kod bolesnika nego kod zdravih osoba.
English: How to take STAYVEER
Croatian: Kako uzimati STAYVEER
English: Intensified monitoring is recommended during the discontinuation period.
Croatian: Preporučuje se intenzivno praćenje bolesnika tijekom perioda prekida uzimanja lijeka.
English: In the post-marketing period there have been rare reports of pulmonary oedema in patients treated with STAYVEER who had a suspected diagnosis of pulmonary veno-occlusive disease.
Croatian: postmarketinškom razdoblju rijetko su zabilježeni slučajevi plućnog edema u bolesnika koji su dobivali STAYVEER i u kojih je postojala sumnja na okluzivnu bolest plućnih vena.
English: In this open-label randomised study with the bosentan 32 mg dispersible tablet formulation, 64 children with stable PAH from 3 months to 11 years of age were randomised to 24 weeks' bosentan treatment 2 mg/kg twice daily (n = 33) or 2 mg/kg three times daily (n = 31).
Croatian: U ovoj otvorenoj randomiziranoj studiji s 32 mg bosentana u obliku tablete za oralnu suspenziju, 64 djece sa stabilnim PAH-om u dobi od 3 mjeseca do 11 godina randomizirano je u skupine liječenja bosentanom u dozi od 2 mg/kg dvaput na dan (n = 33) ili u dozi od 2 mg/kg triput na dan (n = 31) tijekom 24 tjedna.
English: - The other ingredients in the tablet core are maize starch, pregelatinised starch, sodium starch glycolate (Type A), povidone, glycerol dibehenate and magnesium stearate.
Croatian: - Drugi sastojci u jezgri tablete su kukuruzni škrob, prethodno gelirani škrob, natrijev škroboglikolat vrste A, povidon, gliceroldibehenat i magnezijev stearat.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati STAYVEER Lijek čuvajte izvan pogleda i dohvata djece.
English: You need to use a barrier form of birth control - like a condom, diaphragm or vaginal sponge - in addition to any of these kinds of hormonal birth control.
Croatian: Stoga morate također primjenjivati metodu fizičke barijere - npr. kondom, dijafragma ili kontracepcijska spužva - uz bilo koje od navedenih vrsta hormonalne kontracepcije.
English: • nausea (urge to vomit)
Croatian: • mučninu (nagon na povraćanje)
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
English: • Thrombocytopenia (low number of blood platelets)
Croatian: • Trombocitopenija (smanjen broj krvnih pločica)
English: The median exposure to study treatment was 4.5 (range: 0.5-10.0) days in the bosentan group and 4.0 (range: 2.5-6.5) days in the placebo group.
Croatian: Medijan izloženosti ispitivanom liječenju bio je 4,5 (raspon 0,5-10,0) dana u skupini koja je primala bosentan i 4,0 (raspon 2,5-6,5) dana u skupini koja je primala placebo.
English: 3 Headache was reported in 11.5% of patients on bosentan and 9.8% of patients on placebo.
Croatian: 3 Glavobolja je prijavljena u 11,5% bolesnika koji su dobivali bosentan i 9,8% bolesnika koji su dobivali placebo.
English: Aminotransferase levels must then be checked within 3 days after re-introduction, then again after a further 2 weeks, and thereafter according to the recommendations above.
Croatian: Ponovno liječenje treba biti u skladu sa smjernicama danim u dijelu 4.2. Vrijednosti aminotransferaza treba provjeriti do 3 dana nakon ponovnog početka liječenja, nakon 2 tjedna te potom u skladu s gore navedenim preporukama.
English: It cannot be excluded that this may affect your ability to father a child. Talk to your doctor if you have any questions or concerns about this.
Croatian: Ne može se isključiti mogućnost da to utječe na Vašu sposobnost da imate dijete.
English: Monitoring of cholesterol levels and subsequent dosage adjustment should be considered.
Croatian: Treba pratiti razinu kolesterola i u skladu s njom po potrebi prilagoditi dozu simvastatina.