FrancophonIA/ELRC3.0 huggingface dataset:
English: At adult age (Day 69 post partum), no effects of bosentan were detected at 1.3 (males) and 2.6 (females) times the therapeutic exposure in children with PAH.
Slovenian: Pri odrasli starosti (69. dan po skotitvi) niso opazili učinkov bosentana pri 1,3-kratniku (samci) in 2,6-kratniku (samice) izpostavljenosti pri otrocih s PAH.
English: No effect of bosentan on time to healing of digital ulcers was observed in either study.
Slovenian: Učinka bosentana na čas ozdravljenja razjed prstov niso opazili v nobeni študiji.
English: In BREATHE-3, the most frequent adverse reactions were flushing (21%), headache, and abnormal liver function test (each 16%).
Slovenian: V študiji BREATHE-3 so bili najpogostejši neželeni učinki rdečica (21 %), glavobol in nenormalni testi delovanja jeter (po 16 %).
English: In neonates with persistent pulmonary hypertension of the newborn (PPHN), the benefit of bosentan has not been shown in the standard-of-care treatment.
Slovenian: Pri novorojenčkih s trdovratno pljučno hipertenzijo novorojenčka (PPHN) korist bosentana pri zdravljenju s standardno terapijo ni bila dokazana.
English: For white high-density polyethylene bottles:
Slovenian: Za bele plastenke iz polietilena visoke gostote:
English: In the post-marketing period rare cases of unexplained hepatic cirrhosis were reported after prolonged therapy with STAYVEER 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 STAYVEER pri bolnikih s številnimi drugimi sočasnimi boleznimi in zdravljenji z zdravili.
English: Tacrolimus, sirolimus: Co-administration of tacrolimus or sirolimus and STAYVEER has not been studied in man but co-administration of tacrolimus or sirolimus and STAYVEER may result in increased plasma concentrations of bosentan in analogy to co-administration with cyclosporine A. Concomitant STAYVEER may reduce the plasma concentrations of tacrolimus and sirolimus.
Slovenian: Takrolimus, sirolimus: Sočasne uporabe zdravila STAYVEER s takrolimusom in sirolimusom pri človeku sicer niso preučili, lahko pa sočasno dajanje takrolimusa ali sirolimusa z zdravilom STAYVEER povzroči povišane plazemske koncentracije bosentana po analogiji sočasnega dajanja ciklosporina A. Sočasno dajanje zdravila STAYVEER lahko zniža plazemske koncentracije takrolimusa in sirolimusa.
English: In vitro, bosentan inhibits the bile salt export pump in hepatocyte cultures.
Slovenian: In vitro bosentan v hepatocitnih kulturah zavira črpalko žolčnih soli.
English: We suggest you write the date of your most recent test and also of your next test (ask your doctor for the date) on the Patient Alert Card, to help you remember when your next test is due.
Slovenian: da si datum zadnje in naslednje preiskave (zdravnika prosite za datum) zapišete na Opozorilno kartico za bolnika, da si boste lažje zapomnili, kdaj imate naslednjo preiskavo.
English: An increase in minute ventilation and a decrease in oxygen saturation were observed, and the most frequent adverse event was dyspnoea, which resolved with discontinuation of bosentan.
Slovenian: Opazili so zvišanje vdihov na minuto in zmanjšanje zasičenosti s kisikom, pri čemer je bil najpogostejši neželeni učinek dispneja, ki je izginila s prekinitvijo uporabe bosentana.
English: The differences between the two groups, 125 mg twice daily and 250 mg twice daily, were not statistically significant but there was a trend towards improved exercise capacity in the group treated with 250 mg twice daily.
Slovenian: Razlike med skupinama z odmerkom 125 mg dvakrat na dan in 250 mg dvakrat na dan niso bile statistično značilne, čeprav je bil prisoten trend izboljšanja fizične zmogljivosti v skupini, ki je jemala odmerek
English: After 16 weeks, the mean placebo-corrected increase in 6-minute walk distance was 53 metres (p = 0.0079), reflecting improvement in exercise capacity.
Slovenian: Po 16 tednih je bilo povprečje s placebom korigiranega podaljšanja razdalje, prehojene v 6 minutah, 53 metrov (p = 0,0079), kar je kazalo izboljšanje zmogljivosti bolnikov za telesno vadbo.
English: STAYVEER therefore causes blood vessels to expand and belongs to the class of medicines called “endothelin receptor antagonists”.
Slovenian: Zdravilo STAYVEER tako povzroči razširitev krvnih žil in sodi v skupino zdravil, imenovanih „antagonisti endotelinskih receptorjev”.
English: In patients with evidence of the presence of cholestasis, the exposure to the active metabolite may be increased.
Slovenian: Pri bolnikih z znaki holestaze je lahko izpostavljenost aktivnemu presnovku večja.
English: Though the number of patients included was limited and with high variability, these data indicate a marked increase in the exposure to bosentan and its primary metabolite Ro 485033 in patients with moderate liver function impairment (Child-Pugh class B).
Slovenian: Čeprav je bilo število vključenih bolnikov omejeno in so se med seboj močno razlikovali, nakazujejo ti podatki na veliko povešanje izpostavljenosti bosentanu in njegovemu primarnemu presnovku Ro 485033 pri bolnikih z zmerno okvaro delovanja jeter (razred B po klasifikaciji Child-Pugh).
English: During treatment with STAYVEER, your doctor will arrange for regular blood tests to check for changes in your liver function and haemoglobin level.
Slovenian: Med zdravljenjem z zdravilom STAYVEER bo vaš zdravnik odredil redne krvne preiskave, s katerimi bo nadziral spremembe v delovanju vaših jeter in v ravni hemoglobina.
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: • Redno posodobljena poročila o varnosti zdravila (PSUR) 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: Inhibition of these isoenzymes may increase the plasma concentration of bosentan (see ketoconazole).
Slovenian: Zaviranje teh izoencimov lahko poviša koncentracijo bosentana v plazmi (glejte ketokonazol).
English: • sirolimus or tacrolimus, which are medicines used after transplants, as these are not recommended to be used together with STAYVEER.
Slovenian: • sirolimus ali takrolimus, zdravili, ki se uporabljata pri presaditvah, saj se njuna uporaba skupaj z zdravilom STAYVEER ne priporoča,
English: The same recommendations apply to reintroduction of STAYVEER after treatment interruption (see section 4.4).
Slovenian: Enaka priporočila veljajo ob ponovni uvedbi zdravila STAYVEER po prekinitvi zdravljenja (glejte poglavje 4.4).
English: STAYVEER widens the pulmonary arteries, making it easier for the heart to pump blood through them.
Slovenian: Zdravilo STAYVEER razširi pljučne arterije in olajša srcu črpanje krvi skozi te žile.
English: The aetiology of PAH, according to Dana Point classification, included idiopathic PAH (46%), heritable PAH (3%), associated PAH after corrective cardiac surgery (38%), and PAH related to congenital heart disease associated with systemic-topulmonary shunts, including Eisenmenger syndrome (13%).
Slovenian: Etiologija PAH po klasifikaciji Dana Point je vključevala idiopatsko PAH (46 %), dedno PAH (3 %), PAH po korektivni srčni operaciji (38 %) in PAH, povezani s prirojeno boleznijo srca, povezano s sistemsko pljučnim šantom, vključno z
English: However, there was no evidence of bosentan affecting thyroid function (thyroxine, TSH) in humans.
Slovenian: Ni pa bilo nobenih dokazov, da bi bosentan vplival na delovanje ščitnice (tiroksin, TSH) pri ljudeh.
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 STAYVEER.
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 STAYVEER ne priporoča,
English: No drug-drug interaction data are available with the other sulfonylureas.
Slovenian: Za druge sulfonilsečnine podatkov o medsebojnem delovanju zdravil ni.
English: STAYVEER 125 mg film-coated tablets EU/1/13/832/002
Slovenian: STAYVEER 125 mg filmsko obložene tablete EU/1/13/832/002
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,
English: However, some patients who show no response after 8 weeks of treatment with STAYVEER may respond favourably after an additional 4 to 8 weeks of treatment.
Slovenian: STAYVEER ne pokažejo nobenega odziva, se lahko ugodno odzovejo po dodatnih 4 ali 8 tednih zdravljenja.
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:
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: Do not stop taking STAYVEER unless your doctor tells you to.
Slovenian: Zdravilo STAYVEER jemljite, dokler vam vaš zdravnik ne reče, da ga nehajte jemati.
English: Before the initiation of STAYVEER treatment in women of childbearing potential, the absence of pregnancy should be checked, appropriate advice on reliable methods of contraception provided, and reliable contraception initiated.
Slovenian: Pred začetkom zdravljenja z zdravilom STAYVEER je treba pri ženskah v rodni dobi izključiti nosečnost, jim nuditi ustrezen nasvet v zvezi z zanesljivimi načini kontracepcije in začeti z zanesljivo kontracepcijo.
English: The impact of moderately impaired liver function (Child-Pugh class B) on the pharmacokinetics of bosentan and its primary metabolite Ro 48-5033 was investigated in a study including 5 patients with pulmonary hypertension associated with portal hypertension and Child-Pugh class B hepatic impairment, and 3 patients with PAH from other causes and normal liver function.
Slovenian: Vpliv zmerno okvarjenega delovanja ledvic (razred B po klasifikaciji Child-Pugh) na farmakokinetiko bosentana in njegov primarni presnovek Ro 48-5033 so raziskali v študiji, v katero je bilo vključenih 5 bolnikov s pljučno hipertenzijo, povezano s portalno hipertenzijo in okvarjenim delovanjem jeter razreda B po klasifikaciji Child-Pugh, in 3 bolniki s PAH zaradi drugih razlogov in normalnim delovanjem jeter.
English: Therefore, you must not take STAYVEER if you are pregnant and you must also not become pregnant while taking STAYVEER.
Slovenian: Zato tega zdravila ne smete jemati, če ste noseči, v času, ko ga jemljete, pa tudi ne smete zanositi.
English: Survival estimates were lower in the subgroup of patients with PAH secondary to systemic sclerosis.
Slovenian: Ocenjeno preživetje je bilo manjše v podskupini bolnikov s PAH, ki se je razvila zaradi sistemske skleroze.
English: AC-052-356 was an open-label, uncontrolled study; 10 of the 19 paediatric patients were on concomitant bosentan and epoprostenol therapy during the 12week study.
Slovenian: AC-052-356 je bila nenadzorovana študija z znanim zdravilom; 10 od 19 pediatričnih bolnikov je v času 12-tedenske študije sočasno jemalo bosentan in epoprostenol.
English: • Pulmonary arterial hypertension (PAH): PAH is a disease of severe narrowing of the blood vessels in the lungs resulting in high blood pressure in the blood vessels (the pulmonary arteries) that carry blood from the heart to the lungs.
Slovenian: PAH je bolezen hude zožitve krvnih žil v pljučih, ki povzroči visok krvni tlak v krvnih žilah v pljučih (pljučnih arterijah), ki prenašajo kri iz srca v pljuča.
English: Rare (may affect up to one in 1000 people):
Slovenian: Redki (prizadenejo lahko do 1 od 1.000 bolnikov):
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).
Slovenian: Po 16 tednih so opazili pomembna izboljšanja od izhodiščne zmogljivosti za telesno vadbo: povprečno povečanje razdalje, prehojene v 6-minutnem preizkusu s hojo: 91,4 metra s povprečne izhodiščne razdalje 332,6 metra (p < 0,001).
English: In both studies, patients on bosentan were less likely to develop multiple new digital ulcers during the study and took longer to develop each successive new digital ulcer than did those on placebo.
Slovenian: V obeh študijah so bolniki, zdravljeni z bosentanom, med študijo razvili manj novih razjed na prstih in so potrebovali dlje, da so razvili vsako naslednjo razjedo kot bolniki, zdravljeni s placebom.
English: For children aged 1 year and older, treatment with STAYVEER 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 STAYVEER običajno začne z 2 mg na kg telesne mase dvakrat dnevno (zjutraj in zvečer).
English: Your liver and blood values will be monitored during treatment with STAYVEER (see section 2).
Slovenian: Med zdravljenjem z zdravilom STAYVEER bodo spremljali vaše jetrne in krvne vrednosti (glejte poglavje 2).
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.
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 STAYVEER.
English: Patients with suboptimal response to inhaled nitric oxide (iNO) despite at least 4 hours of continuous treatment were treated with bosentan dispersible tablets at 2 mg/kg twice daily (N = 13) or placebo (N = 8) via nasogastric tube as add-on therapy on top of iNO until complete weaning of iNO or until treatment failure (defined as need for extra-corporeal membrane oxygenation [ECMO] or initiation of alternative pulmonary vasodilator), and for a maximum of 14 days.
Slovenian: Bolniki s suboptimalnim odzivom na vdihavanje dušikovega oksida (iNO) kljub vsaj 4 ure trajajoči neprekinjeni terapiji so prejemali disperzibilne tablete bosentana 2 mg/kg dvakrat dnevno (N = 13) ali placebo (N = 8) po nazogastrični sondi kot dodatno terapijo poleg iNO do popolne ukinitve iNO ali do neuspeha zdravljenja (opredeljen kot potreba po izventelesni membranski oksigenaciji [ECMO] ali uvedba alternativnega pljučnega vazodilatatorja), in to največ 14 dni.
English: STAYVEER is used to treat:
Slovenian: Zdravilo STAYVEER uporabljamo za zdravljenje:
English: The Kaplan-Meier event-free estimate for worsening of PAH (death, lung transplantation, or hospitalisation for PAH worsening) at 2 years was 78.9%.
Slovenian: Po Kaplan-Meierjevem izračunu je bilo po 2 letih brez dogodkov poslabšanja PAH (smrt, presaditev pljuč ali hospitalizacija zaradi poslabšanja PAH) 78,9 % bolnikov.
English: When treatment with STAYVEER is initiated in patients who require ritonavir-boosted protease inhibitors, the patient's tolerability of STAYVEER 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 STAYVEER uvede pri bolnikih, ki potrebujejo zaviralce proteaze, pospešene z ritonavirjem, je treba prenašanje zdravila STAYVEER pri teh bolnikih skrbno nadzirati s posebno pozornostjo na začetku faze uvajanja v zvezi s tveganjem hipotenzije in preiskavami delovanja jeter.
English: • Gastrooesophageal reflux disease (acid reflux)
Slovenian: • gastroezofagealna refluksna bolezen (refluks kisline)
English: Bosentan has been shown to be teratogenic in rats at plasma levels higher than 1.5 times the plasma concentrations achieved at the therapeutic dose in humans.
Slovenian: Za bosentan so ugotovili, da je teratogen pri podganah pri plazemskih koncentracijah, več kot 1,5-krat višjih od plazemskih koncentracij, doseženih pri ljudeh po terapevtskih odmerkih.
English: Development of testicular tubular atrophy and impaired fertility has been linked with chronic administration of endothelin receptor antagonists in rodents.
Slovenian: Razvoj tubularne atrofije testisov in zmanjšana plodnost sta bila pri glodavcih povezana s kroničnim dajanjem antagonistov endotelinskih receptorjev.
English: If you forget to take STAYVEER
Slovenian: Če ste pozabili vzeti zdravilo STAYVEER
English: Both glibenclamide and bosentan inhibit the bile salt export pump, which could explain the elevated aminotransferases.
Slovenian: Tako glibenklamid kot bosentan zavirata črpalko žolčnih soli, kar bi lahko razložilo povišanje aminotransferaz.
English: The effect of bosentan on reduction of the number of new digital ulcers was more pronounced in patients with multiple digital ulcers.
Slovenian: Učinek bosentana na zmanjšanje števila novih razjed prstov je bil jasnejši pri bolnikih z več razjedami.
English: STAYVEER can be taken with or without food.
Slovenian: Zdravilo STAYVEER lahko jemljete s hrano ali brez nje.
English: Dyspnoea measurement during walk tests showed an improvement in bosentan-treated patients.
Slovenian: Meritve dispneje med preskusi s hojo so pokazale izboljšanje pri bolnikih, ki so jemali bosentan.
English: After an increase in dose, an additional test will be done after 2 weeks.
Slovenian: Po zvišanju odmerka zdravila bo po 2 tednih opravljena še ena dodatna preiskava.
English: Appropriate precautions must be taken for women of childbearing potential (see sections 4.3, 4.4 and 4.6).
Slovenian: Pri ženskah v rodni dobi moramo upoštevati ustrezne varnostne ukrepe (glejte poglavja 4.3, 4.4 in 4.6).
English: • hormonal contraceptives, which are not effective as the sole method of contraception when you take STAYVEER.
Slovenian: • hormonsko kontracepcijo, ki kot edini način preprečevanja zanositve ni učinkovit, če jemljete zdravilo STAYVEER.
English: In patients with mildly impaired liver function (Child-Pugh class A) no relevant changes in the pharmacokinetics have been observed.
Slovenian: Okvarjeno delovanje jeter Pri bolnikih z blago okvarjenim delovanjem jeter (Child-Pugh razred A) niso opazili kakih pomembnih sprememb v farmakokinetiki.
English: • Monthly pregnancy tests are recommended during treatment to allow early detection of pregnancy
Slovenian: • se med zdravljenjem zaradi zgodnjega ugotavljanja nosečnosti priporočajo mesečni testi nosečnosti.
English: If you stop taking STAYVEER
Slovenian: Če ste prenehali jemati zdravilo STAYVEER
English: Control was placebo plus current therapy.
Slovenian: Kontrolna skupina je prejemala placebo in redno terapijo.
English: A careful benefit/risk assessment should be made, taking into consideration the liver toxicity of bosentan (see sections 4.4 and 4.8).
Slovenian: Skrbno moramo oceniti razmerje med koristjo in tveganjem, pri čemer upoštevamo toksičen vpliv bosentana za jetra (glejte poglavji 4.4 in 4.8).
English: Similar effects would be expected with other ritonavir-boosted protease inhibitors (see section 4.4).
Slovenian: Podobni učinki se pričakujejo z drugimi zaviralci proteaze, ki jih okrepi ritonavir (glejte poglavje 4.4).
English: Fluconazole and other inhibitors of both CYP2C9 and CYP3A4: Co-administration with fluconazole, which inhibits mainly CYP2C9, but to some extent also CYP3A4, could lead to large increases in plasma concentrations of bosentan.
Slovenian: Flukonazol in drugi zaviralci CYP2C9 in CYP3A4: Sočasno dajanje s flukonazolom, ki zavira predvsem CYP2C9, do določene mere pa tudi CYP3A4, lahko povzroči do veliko povišanje plazemskih koncentracij bosentana.
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).
Slovenian: 33 od teh bolnikov je nadaljevalo zdravljenje z disperzibilnimi tabletami bosentana v odmerku 4 mg/kg dvakrat dnevno v nenadzorovani podaljšani fazi študije FUTURE 2, kjer je skupno mediano trajanje zdravljenja znašalo 2,3 leta (razpon: 0,2 do 5,0 let).
English: In this study, fluid retention was manifested by early weight gain, decreased haemoglobin concentration and increased incidence of leg oedema.
Slovenian: V tej študiji se je zadrževanje tekočine pokazalo kot zgodnje povečanje telesne mase, znižanje koncentracije hemoglobina in povečanje števila primerov edemov nog.
English: There are no studies to demonstrate beneficial effects of STAYVEER treatment on survival.
Slovenian: Raziskav, s katerimi bi pokazali koristne učinke zdravljenja z zdravilom STAYVEER na preživetje bolnikov, ni.
English: Teratogenic effects, including malformations of the head and face and of the major vessels, were dose dependent.
Slovenian: kot so malformacije glave, obraza in velikih žil, so bili odvisni od odmerka.
English: Blood tests for anaemia
Slovenian: Krvne preiskave za anemijo
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.
Slovenian: V študiji AC-052-373 (FUTURE 3) z disperzibilnimi tabletami je bila izpostavljenost bosentanu pri bolnikih, zdravljenih z 2 mg/kg dvakrat dnevno, primerljiva s tisto v študiji FUTURE 1.
English: Do not take a double dose to make up for forgotten tablets.
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnjega.
English: White high-density polyethylene bottles with a silica gel desiccant containing 56 film-coated tablets.
Slovenian: Bele plastenke iz polietilena visoke gostote s silikagelnim sušilom, ki vsebujejo 56 filmsko obloženih tablet.
English: • Elevated liver function tests with hepatitis (inflammation of the liver) including possible exacerbation of underlying hepatitis and/or jaundice (yellowing of the skin or the whites of the eyes)
Slovenian: • zvišani izsledki preiskav delovanja jeter s hepatitisom (vnetjem jeter), vključno z možnim poslabšanjem obstoječega hepatitisa, in/ali zlatenica (porumenelost kože ali beločnice v očeh)
English: For further details please refer to section 4.5.
Slovenian: Za podrobnosti glejte poglavje 4.5.
English: 4 years For white high-density polyethylene bottles, use within 30 days after the first opening.
Slovenian: 4 leta Vsebino belih plastenk iz polietilena visoke gostote porabite v 30 dneh po prvem odprtju.
English: Should this occur, starting treatment with diuretics is recommended, or the dose of existing diuretics should be increased.
Slovenian: Če pride do tega, priporočamo uvedbo zdravljenja z diuretiki ali povišanje odmerka diuretika, ki ga bolnik že uporablja.
English: However, STAYVEER may induce hypotension, with symptoms of dizziness, blurred vision or syncope that could affect the ability to drive or use machines.
Slovenian: Zdravilo STAYVEER lahko povzroči hipotenzijo s simptomi omotice, zamegljenega vida ali sinkope, ki bi lahko vplivala na sposobnost vožnje in upravljanja strojev.