FrancophonIA/ELRC3.0 huggingface dataset:
English: If it is possible that you could become pregnant, use a reliable form of birth control (contraception) while you are taking STAYVEER.
Slovenian: Če je možno, da zanosite, uporabite zanesljivo obliko kontracepcije, medtem ko jemljete zdravilo
English: At steady state, bosentan plasma concentrations were 3- to 4-fold higher than with bosentan alone.
Slovenian: V stanju dinamičnega ravnovesja so bile plazemske koncentracije bosentana 3- do 4-krat višje kot pri jemanju bosentana samega.
English: The combination of bosentan and epoprostenol has been investigated in two studies: AC-052-355 (BREATHE-2) and AC-052-356 (BREATHE-3).
Slovenian: Kombinacija z epoprostenolom Kombinacijo bosentana in epoprostenola so raziskovali v dveh študijah: AC-052-355 (BREATHE-2)
English: This study was primarily designed as a pharmacokinetic study (see section 5.2).
Slovenian: Ta študija je bila zasnovana predvsem kot farmakokinetična študija (glejte poglavje 5.2).
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.
Slovenian: V 20 integriranih s placebom nadzorovanih študijah so opazili povišanja vrednosti jetrnih aminotransferaz za ≥ 3 × vrednost ZMN, in to pri 11,2 % bolnikov, ki so jemali bosentan, in 2,4 % bolnikov, ki so prejemali placebo.
English: On day 9, plasma concentrations of bosentan were approximately 5-fold higher than with bosentan administered alone.
Slovenian: 9. dan so bile koncentracije bosentana v plazmi približno 5-krat višje kot pri dajanju samega bosentana.
English: Therefore, women of childbearing potential must not use hormonal contraceptives (including oral, injectable, transdermal or implantable forms) as the sole method of contraception but must use an additional or an alternative reliable method of contraception.
Slovenian: (vključno s peroralnimi, transdermalnimi oblikami, oblikami za vbrizganje ali vsadki) kot edinega načina kontracepcije, temveč morajo uporabljati dodatno ali drugo zanesljivo metodo kontracepcije.
English: He had symptoms of nausea, vomiting, hypotension, dizziness, sweating and blurred vision.
Slovenian: hipotenzije, omotičnosti, potenja in zamegljenega vida.
English: Consequently, bosentan is not expected to increase the plasma concentrations of medicinal products metabolised by these isoenzymes.
Slovenian: Zato ne pričakujemo, da bi bosentan povišal plazemske koncentracije zdravil, ki jih presnavljajo ti izoencimi.
English: Anaphylaxis and/or angioedema1
Slovenian: redki anafilaksa in/ali angioedem1
English: It was primarily designed as a pharmacokinetic study (see section 5.2).
Slovenian: Zasnovana je bila predvsem kot farmakokinetična študija (glejte poglavje 5.2).
English: Some patients taking STAYVEER were found to have abnormal liver function tests.
Slovenian: Nekateri bolniki, ki so jemali zdravilo STAYVEER, so imeli nenormalne rezultate preiskav delovanja jeter.
English: Hypersensitivity reactions (including dermatitis, pruritus and rash)2
Slovenian: Bolezni imunskega sistema pogosti preobčutljivostne reakcije (vključno z dermatitisom, pruritusom in izpuščajem)2
English: In animal models of pulmonary hypertension, chronic oral administration of bosentan reduced pulmonary vascular resistance and reversed pulmonary vascular and right ventricular hypertrophy.
Slovenian: Na živalskih modelih pljučne hipertenzije se je po dolgotrajnem peroralnem dajanju bosentana zmanjšal pljučni žilni upor in izboljšala pljučna žilna hipertrofija in hipertrofija desnega prekata.
English: STAYVEER tablets contain bosentan, which blocks a naturally occurring hormone called endothelin-1 (ET-1), which causes blood vessels to narrow.
Slovenian: Tablete zdravila STAYVEER vsebujejo bosentan, ki zavre naravni hormon, imenovan endotelin-1
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila STAYVEER Vsebina pakiranja in dodatne informacije
English: However, no effects on general development, growth, sensory, cognitive function and reproductive performance were detected at 7 (males) and 19 (females) times the human therapeutic exposure at Day 21 post partum.
Slovenian: Kljub temu pa na 21. dan po skotitvi niso opazili nobenih učinkov na splošni razvoj, rast, senzorne in kognitivne funkcije ter na reproduktivno sposobnost pri 7-kratniku (samci) in 19-kratniku (samice)
English: The mean pulmonary vascular resistance was significantly reduced in the bosentan group (with a predominant effect observed in the subgroup of patients with bidirectional intracardiac shunt).
Slovenian: V skupini, ki je prejemala bosentan, je bil povprečni upor pljučnih žil pomembno manjši (pri čemer so največji učinek opazili pri podskupini bolnikov z dvosmernim intrakardialnim šantom).
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).
Slovenian: V tej odprti, randomizirani študiji z bosentanom v obliki 32 mg disperzibilnih tablet je bilo 64 otrok s stabilno PAH, starih od 3 mesecev do 11 let, randomiziranih v 24-tedensko zdravljenje z bosentanom 2 mg/kg dvakrat dnevno (n = 33) ali 2 mg/kg trikrat dnevno (n = 31).
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: 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 STAYVEER.
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 STAYVEER, verjetno svetoval, da začnete z jemanjem 125 mg tablet dvakrat na dan.
English: Bosentan is an inducer of CYP2C9 and CYP3A4 and possibly also of CYP2C19 and the P-glycoprotein.
Slovenian: Bosentan je induktor izoencimov CYP2C9 in CYP3A4 ter morebiti tudi CYP2C19 in P-glikoproteina.
English: The most common adverse reaction was headache of mild to moderate intensity.
Slovenian: Najpogostejši neželeni učinek je bil blag do srednje močan glavobol.
English: • simvastatin (used to treat hypercholesterolaemia).
Slovenian: • simvastatin (uporablja se za zdravljenje zvišane koncentracije holesterola v krvi).
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 STAYVEER 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 STAYVEER nad 2 mg/kg telesne mase ali s povečanjem pogostnosti odmerjanja z dvakrat dnevno na trikrat dnevno niso zvečale (glejte poglavje 5.2).
English: Ketoconazole: Co-administration for 6 days of bosentan 62.5 mg twice daily with ketoconazole, a potent CYP3A4 inhibitor, increased the plasma concentrations of bosentan approximately 2-fold.
Slovenian: Ketokonazol: Pri 6-dnevni sočasni uporabi bosentana v odmerku 62,5 mg dvakrat na dan in ketokonazola, močnega zaviralca CYP3A4, se je plazemska koncentracija bosentana zvišala približno za dvakrat.
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).
Slovenian: Kliničnih izkušenj pri dializno odvisnih bolnikih ni. Na podlagi fizikalno-kemičnih lastnosti in visoke stopnje vezave na beljakovine ne pričakujemo, da bi lahko z dializo iz krvnega obtoka odstranili veliko bosentana (glejte poglavje 4.2).
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.
Slovenian: Tadalafil: Bosentan (125 mg dvakrat na dan) je po sočasnem dajanju večkratnega odmerka zmanjšal sistemsko izpostavljenost tadalafilu (40 mg enkrat na dan) za 42 % in Cmax za 27 %.
English: The mean duration of exposure to bosentan was 1.9 years ± 0.7 years (min: 0.1 years; max: 3.3 years) and patients were observed for a mean of 2.0 ± 0.6 years.
Slovenian: Povprečno trajanje izpostavljenosti bosentanu je bilo 1,9 let ± 0,7 let; (najmanj 0,1 let, največ 3,3 leta), bolnike pa so opazovali povprečno 2,0 ± 0,6 let.
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.
Slovenian: FUTURE 1 je bila odprta, nenadzorovana študija, ki so jo izvajali z bosentanom v obliki disperzibilnih tablet v vzdrževalnem odmerku 4 mg/kg dvakrat dnevno, ki so ga dajali 36 bolnikom,
English: The film-coat contains hypromellose, glycerol triacetate, talc, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172) and ethylcellulose.
Slovenian: Filmska obloga vsebuje hipromelozo, gliceriltriacetat, smukec, titanov dioksid (E171), rumen železov oksid
English: PVC/PE/PVDC/aluminium-blisters containing 14 film-coated tablets.
Slovenian: PVC/PE/PVDC/aluminij pretisni omot s 14 filmsko obloženimi tabletami.
English: 56 film-coated tablets 112 film-coated tablets
Slovenian: 56 filmsko obloženih tablet 112 filmsko obloženih tablet
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).
Slovenian: 122 (študija AC-052-401 [RAPIDS-1]) in 190 (študija AC-052-331 [RAPIDS-2]) odraslih bolnikih s sistemsko sklerozo in boleznijo razjed prstov (bodisi nastajajočimi razjedami prstov ali z anamnezo razjed prstov v prejšnjem letu).
English: There are no data on the safety and efficacy in patients under the age of 18 years.
Slovenian: Pediatrična populacija Podatkov o varnosti in učinkovitosti pri bolnikih pod 18 let ni. Farmakokinetični podatki za zdravilo
English: Gastrooesophageal reflux disease Diarrhoea
Slovenian: Bolezni prebavil pogosti gastroezofagealna refluksna bolezen driska
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,
English: Treatment with bosentan has been associated with dose-dependent elevations in liver aminotransferases and decreases in haemoglobin concentration (see section 4.4).
Slovenian: Zdravljenje z bosentanom so povezovali z zvišanjem vrednosti jetrnih aminotransferaz, odvisnim od odmerka, in znižanjem koncentracije hemoglobina (glejte poglavje 4.4).
English: Plasma concentrations of bosentan metabolites increased about 2-fold in these patients as compared with subjects with normal renal function.
Slovenian: Pri teh bolnikih so se plazemske koncentracije presnovkov bosentana povišale za približno 2-krat v primerjavi z osebami z normalnim ledvičnim delovanjem.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON WITH 56 AND 112 TABLETS
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA S 56 IN 112 TABLETAMI
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.
Slovenian: Mediana izpostavljenost študijskemu zdravljenju je bila v skupini z bosentanom 4,5 (razpon 0,5-10,0) dni, v skupini s placebom pa 4,0 (razpon 2,5-6,5) dni.
English: Of the 22 patients stable at week 8, 6 improved at week 12/16 and 4 deteriorated compared with baseline.
Slovenian: Od 22 v 8. tednu stabilnih bolnikov se je pri 6 bolnikih stanje izboljšalo v 12./16.
English: The pharmacokinetics of bosentan have mainly been documented in healthy subjects.
Slovenian: 5.2 Farmakokinetične lastnosti Farmakokinetiko bosentana so preučevali zlasti pri zdravih osebah.
English: A pooled analysis of uncontrolled paediatric studies conducted in PAH with the bosentan 32 mg dispersible tablet formulation (FUTURE 1/2, FUTURE 3/Extension) included a total of 100 children treated with bosentan 2 mg/kg twice daily (n = 33), 2 mg/kg three times daily (n = 31), or 4 mg/kg twice daily (n = 36).
Slovenian: Združena analiza nenadzorovanih pediatričnih študij pri PAH z bosentanom 32 mg v obliki disperzibilnih tablet (FUTURE 1/2, FUTURE 3/podaljšanje) je zajela skupno 100 otrok, zdravljenih z bosentanom 2 mg/kg dvakrat dnevno (n = 33), 2 mg/kg trikrat dnevno (n = 31) ali 4 mg/kg dvakrat dnevno (n = 36).
English: During treatment with STAYVEER, your doctor will arrange for regular blood tests to check for changes in your liver function.
Slovenian: V času jemanja zdravila STAYVEER bo zdravnik naročil redne preiskave krvi, da preveri, če je prišlo do sprememb v delovanju jeter.
English: Cyclosporine A: Co-administration of STAYVEER and cyclosporine A (a calcineurin inhibitor) is contraindicated (see section 4.3).
Slovenian: Ciklosporin A: Sočasna uporaba zdravila STAYVEER in ciklosporina A (kalcinevrinski zaviralec) je kontraindicirana (glejte poglavje 4.3).
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 zdravnika ali ginekologa vzemite s seboj.
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: Inside your pack of STAYVEER 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.
Slovenian: Izpolnite to kartico in jo ob naslednjem obisku pokažite svojemu zdravniku, da bo bodisi zdravnik ali ginekolog lahko ocenil, ali potrebujete dodatne ali druge zanesljive kontracepcijske metode.
English: Please read this card carefully before starting your treatment with STAYVEER.
Slovenian: Pred začetkom zdravljenja z zdravilom STAYVEER skrbno preberite to kartico.
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.
Slovenian: Ni mogoče izključiti, da bi to lahko vplivalo na vašo sposobnost zaploditi otroka.
English: These cases reinforce the importance of strict adherence to the monthly schedule for monitoring of liver function for the duration of treatment with STAYVEER (see section 4.4).
Slovenian: Ti primeri še poudarjajo pomen doslednosti upoštevanja mesečnega režima nadziranja delovanja jeter v času trajanja zdravljenja z zdravilom
English: In 20 placebo-controlled studies, conducted in a variety of therapeutic indications, a total of 2,486 patients were treated with bosentan at daily doses ranging from 100 mg to 2000 mg and 1,838 patients were treated with placebo.
Slovenian: V 20 s placebom kontroliranih študijah, ki so se izvajale za številne terapevtske indikacije, je bilo skupaj 2.486 bolnikov zdravljenih z bosentanom v dnevnih odmerkih v razponu od 100 mg do
English: ((Front cover))
Slovenian: (( Prednja stran))
English: • Hypersensitivity reactions (including skin inflammation, itching and rash)
Slovenian: • preobčutljivostna reakcija (vključno z vnetjem kože, srbenjem in izpuščajem)
English: No dose adjustment is required in patients undergoing dialysis (see section 5.2).
Slovenian: Prilaganje odmerka pri dializno odvisnih bolnikih ni potrebno (glejte poglavje 5.2).
English: STAYVEER is contraindicated in patients with moderate to severe liver dysfunction (see sections 4.3, 4.4 and 5.2).
Slovenian: Zdravilo STAYVEER je pri bolnikih s srednje in hudo okvarjenim delovanjem jeter kontraindicirano (glejte poglavja 4.3, 4.4 in 5.2).
English: Placebo (n=88) Bosentan (n=80) Placebo (n=91) Bosentan (n=86)
Slovenian: Placebo (n = 88)
English: In the event of clinical deterioration (e.g., decrease in 6-minute walk test distance by at least 10% compared with pre-treatment measurement) despite STAYVEER treatment for at least 8 weeks (target dose for at least 4 weeks), alternative therapies should be considered.
Slovenian: Zdravljenje v primeru kliničnega poslabšanja PAH V primeru poslabšanja kliničnega stanja (denimo, zmanjšanje prehojene razdalje v 6-minutnem preskusu s hojo za vsaj 10 % v primerjavi z rezultatom pred začetkom zdravljenja) kljub 8
English: The estimates may have been influenced by the initiation of epoprostenol treatment in 43/235 patients.
Slovenian: Pri 43/235 bolnikih je na oceno morda vplivalo zdravljenje z epoprostenolom.
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.
Slovenian: V tej skupni populaciji je bila po 1 letu zdravljenja z bosentanom ocena preživetja po metodi Kaplan-Meier 93-odstotna, po 2 letih zdravljenja pa 84-odstotna.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2)
Slovenian: Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
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%).
Slovenian: Pri bolnikih, starih od 3 mesece do 2 leti, je bila dnevna izpostavljenost 7.879·ng h/ml, AUCτ pa 3.939·ng h/ml (CV: 72 %).
English: • The median time to complete weaning from mechanical ventilation was 10.8 days (95% CLs 3.21, 12.21 days) on bosentan and 8.6 days (95% CLs 3.71, 9.66 days) on placebo (p = 0.24).
Slovenian: • mediana časa do popolne ukinitve mehanske ventilacije je bila pri bosentanu 10,8 dni (95-% meje zaupanja [MZ] 3,21; 12,21 dni), pri placebu pa 8,6 dni (95-% meje zaupanja [MZ] 3,71; 9,66 dni) (p = 0,24).
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%).
Slovenian: Pri bolnikih, starejših od 2 let (n = 22) je bila dnevna izpostavljenost 8.820·ng h/ml, AUCτ pa 4.410 ng·h/ml (CV: 58 %).
English: Laboratory abnormalities
Slovenian: Nenormalne laboratorijske vrednosti
English: Sildenafil: Co-administration of bosentan 125 mg twice daily (steady state) with sildenafil 80 mg three times a day (at steady state) concomitantly administered during 6 days in healthy volunteers resulted in a 63% decrease in the sildenafil AUC and a 50% increase in the bosentan AUC.
Slovenian: Sildenafil: Šestdnevno sočasno dajanje bosentana 125 mg dvakrat na dan (stanje dinamičnega ravnovesja) s sildenafilom 80 mg trikrat na dan (v stanju dinamičnega ravnovesja) zdravim prostovoljcem je povzročilo 63 % zmanjšanje AUCτ sildenafila in 50 % povečanje AUCτ bosentana.
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
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 × ZMN med zdravljenjem, vendar pa je prišlo do enega primera hepatitisa 3 dni po prenehanju zdravljenja z bosentanom.
English: STAYVEER 62.5 mg film-coated tablets PVC/PE/PVDC/aluminium-blisters containing 14 film-coated tablets.
Slovenian: STAYVEER 62,5 mg filmsko obložene tablete Pretisni omot iz PVC/PE/PVDC/aluminija s 14 filmsko obloženimi tabletami.
English: Enrolled patients were PAH-treatment-naïve (n = 156) or on a stable dose of sildenafil (n = 29).
Slovenian: (n = 156) ali so prejemali stalni odmerek sildenafila (n = 29).
English: Concomitant use of rifampicin and STAYVEER is not recommended.
Slovenian: Sočasna uporaba rifampicina in zdravila STAYVEER ni priporočljiva.
English: The combination should be used with caution.
Slovenian: Bodite previdni pri uporabi te kombinacije.
English: Therefore, concomitant use of STAYVEER and tacrolimus or sirolimus is not advisable.
Slovenian: Zato sočasno uporabo zdravila STAYVEER in takrolimusa ali sirolimusa odsvetujemo.
English: Treatment with bosentan has been associated with dose-related decreases in haemoglobin concentration (see section 4.8).
Slovenian: Zdravljenje z bosentanom je bilo povezano z majhnim znižanjem koncentracije hemoglobina v odvisnosti od odmerka (glejte poglavje 4.8).
English: > 5 and ≤ 8 × ULN The result should be confirmed by a second liver test; if confirmed, treatment should be stopped and aminotransferase levels monitored at least every 2 weeks.
Slovenian: > 5 in  8  ZMN Rezultat je treba potrditi še z drugo preiskavo jetrnih encimov; če je potrjen,
English: Uncommon (may affect up to one in 100 people):
Slovenian: Občasni (prizadenejo lahko do 1 od 100 bolnikov):
English: The pharmacokinetics of bosentan have not been studied in patients with Child-Pugh class C hepatic impairment.
Slovenian: Farmakokinetike bosentana pri bolnikih z okvarjenim delovanjem jeter razreda C po klasifikaciji Child-Pugh niso raziskali.
English: • nausea (urge to vomit)
Slovenian: • navzeo (siljenje na bruhanje)
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,
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.
Slovenian: Hormonska kontracepcija: Sočasno dajanje bosentana 25 mg dvakrat na dan 7 dni s peroralnim kontraceptivom v enem odmerku, vsebujočim noretisteron 1 mg in etinilestradiol 35 µg, je zmanjšalo
English: STAYVEER may harm the development of the foetus.
Slovenian: Zdravilo STAYVEER lahko škoduje razvoju ploda.
English: STAYVEER 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 STAYVEER se uporablja tudi za zmanjševanje števila novih razjed prstov pri bolnikih s sistemsko sklerozo in nastajajočimi razjedami prstov (glejte poglavje 5.1).
English: A Patient Alert Card providing important safety information that patients need to be aware of before and during treatment with STAYVEER 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 STAYVEER, je priložena pakiranju zdravila.