FrancophonIA/ELRC3.0 huggingface dataset:
English: In the event of associated clinical symptoms of liver injury, i.e., nausea, vomiting, fever, abdominal pain, jaundice, unusual lethargy or fatigue, flu-like syndrome (arthralgia, myalgia, fever), treatment must be stopped and re-introduction of STAYVEER is not to be considered.
Slovenian: V primeru kliničnih simptomov, povezanih z okvarjenim delovanjem jeter, npr. slabost, bruhanje, povišana telesna temperatura, bolečine v trebuhu, zlatenica, nenavadna letargija ali utrujenost, gripi podobni simptomi (bolečine v sklepih, bolečine v mišicah, povišana telesna temperatura), moramo zdravljenje prekiniti in ponovna uvedba zdravljenja z zdravilom STAYVEER ni dovoljena.
English: In the post-marketing period, cases of anaemia requiring red blood cell transfusion have been reported (see section 4.8).
Slovenian: V obdobju po uvedbi zdravila na trg so poročali o primerih anemije, zaradi katere je bila potrebna transfuzija eritrocitov (glejte poglavje 4.8).
English: Oral use Read the package leaflet before use
Slovenian: Peroralna uporaba Pred uporabo preberite priloženo navodilo!
English: The most frequent adverse events in the bosentan- and placebo-treated patients were, respectively, anaemia or haemoglobin decrease (7 and 2 patients), generalised oedema (3 and 0 patients), and vomiting (2 and 0 patients).
Slovenian: Najpogostejši neželeni učinki pri bolnikih, zdravljenih z bosentanom oziroma placebom, so bili v navedenem zaporedju: anemija ali znižanje vrednosti hemoglobina (7 oz. 2 bolnika), generalizirani edem (3 oz. 0 bolnikov) in bruhanje (2 oz. 0 bolnikov).
English: • jaundice (yellowing of your skin or the whites of your eyes)
Slovenian: • zlatenico (porumenelost kože ali beločnice v očeh)
English: Liver aminotransferase levels must be measured prior to initiation of treatment and subsequently at monthly intervals for the duration of treatment with STAYVEER.
Slovenian: Ravni jetrnih aminotransferaz moramo izmeriti pred začetkom zdravljenja in nato redno enkrat na mesec ves čas zdravljenja z zdravilom STAYVEER.
English: STAYVEER has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo STAYVEER nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Birth control based on hormones - such as oral contraceptives or birth control pills, hormone injections, implants, or birth control skin patches don't reliably prevent pregnancy in women who are taking STAYVEER.
Slovenian: Hormonske kontracepcijske metode, kot so peroralni kontraceptivi ali kontracepcijske tabletke, hormonske injekcije, vsadki ali kožni obliži nosečnosti ne preprečujejo zanesljivo pri ženskah, ki jemljejo zdravilo STAYVEER.
English: The study was primarily designed as a pharmacokinetic study (see section 5.2), and efficacy endpoints were only exploratory.
Slovenian: Študija je bila zasnovana predvsem kot farmakokinetična študija (glejte poglavje 5.2) in opazovani dogodki so bili zgolj raziskovalni.
English: Anaemia may occasionally require blood transfusion
Slovenian: Zaradi anemije je treba bolnike včasih zdraviti s krvno transfuzijo.
English: STAYVEER 62.5 mg film-coated tablets EU/1/13/832/001
Slovenian: STAYVEER 62,5 mg filmsko obložene tablete EU/1/13/832/001
English: Patients were divided into three body-weight groups and dosed with bosentan at approximately 2 mg/kg twice daily for 12 weeks.
Slovenian: Bolnike so razvrstili v tri skupine glede na telesno maso in jim določili odmerek bosentana približno 2 mg/kg dvakrat dnevno, ki so ga prejemali 12 tednov.
English: Adverse events of liver abnormalities and anaemia/haemoglobin decrease occurred in 9% and 5% of patients, respectively.
Slovenian: Neželeni učinki v obliki nenormalnih jetrnih testov in anemije/znižane vrednosti hemoglobina so se pojavili pri 9 % oziroma 5 % bolnikov.
English: • if you are taking cyclosporine A (a medicine used after a transplant or to treat psoriasis)
Slovenian: • če jemljete ciklosporin A (zdravilo, ki se uporablja po presaditvi ali za zdravljenje luskavice).
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).
Slovenian: Mediana trajanja zdravljenja z bosentanom in placebom je bila 4,5 dni (razpon 0,5-10,0 dni) oziroma 4,0 dni (razpon 2,5-6,5 dni).
English: This metabolite is mainly excreted unchanged via the bile.
Slovenian: Ta presnovek se večinoma izloči v nespremenjeni obliki z žolčem.
English: OUTER CARTON/BLISTERS NAME OF THE MEDICINAL PRODUCT
Slovenian: ZUNANJA ŠKATLA/PRETISNI OMOT IME ZDRAVILA
English: The possibility of altered efficacy of medicinal products metabolised by these isoenzymes should be considered.
Slovenian: Upoštevajte možnost spremenjene učinkovitosti zdravil, ki jih presnavljajo ti izoencimi.
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).
Slovenian: V študiji AC-052-331 so bile ustrezne številke med 24-tedensko dvojno slepo terapijo 1,9 proti 2,7 novih razjed prstov v enakem zaporedju (p = 0,0351).
English: years to 11 years old, 15 (23.4%) were between 1 and 2 years old, and 6 (9.4%) were between 3 months and 1 year old.
Slovenian: 43 otrok (67,2 %) je bilo starih od ≥ 2 leti do 11 let, 15 (23,4 %) je bilo starih od 1 do 2 leti, 6 (9,4 %) pa je bilo starih od 3 mesece do 1 leta.
English: Bosentan was negative in tests for genotoxicity.
Slovenian: Test genotoksičnosti bosentana je bil negativen.
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.
Slovenian: V študiji FUTURE-4 se je pri 6 od 13 novorojenčkov s PPHN, zdravljenih z bosentanom, hemoglobin med zdravljenjem znižal od vrednosti znotraj referenčnega razpona ob izhodišču do vrednosti pod spodnjo mejo normale.
English: In the pooled analysis of 100 PAH children from uncontrolled paediatric studies FUTURE 1/2 and FUTURE 3/Extension, a decrease in haemoglobin concentration from baseline to below 10 g/dL was reported in 10.0% of patients.
Slovenian: V skupni analizi 100 otrok s PAH iz nenadzorovanih pediatričnih študij FUTURE 1/2 in FUTURE 3/podaljšanje, so o znižanih koncentracijah hemoglobina od izhodiščne vrednosti do manj kot 10 g/dl poročali pri 10,0 % bolnikov.
English: The PAH for which STAYVEER is indicated can be:
Slovenian: PAH, zaradi katere je zdravilo STAYVEER predpisano, je lahko:
English: At baseline in FUTURE 1, 9 patients were taking epoprostenol.
Slovenian: FUTURE 1 9 bolnikov jemalo epoprostenol.
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.
Slovenian: V študiji AC-052-331 so bolniki morali imeti vsaj eno razjedo na prstih, ki je nastopila nedavno in v obeh študijah je 85% bolnikov imelo nastajajoče razjede prstov.
English: The steady-state AUC of bosentan was 9% higher and the AUC of the active metabolite, Ro 48-5033, was 33% higher in patients with mild hepatic impairment than in healthy volunteers.
Slovenian: V stanju dinamičnega ravnovesja je bila vrednost AUCτ bosentana za 9 % večja in vrednost AUCτ za aktivni presnovek, Ro 48-5033, za 33 % večja pri bolnikih z blago okvarjenim delovanjem jeter kot pri zdravih prostovoljcih.
English: At steady state, AUCτ was 6,165 ng·h/mL (CV: 133%, n = 7), which is similar to the exposure observed in adult PAH patients receiving 125 mg twice daily and taking into account a blood/plasma distribution ratio of 0.6.
Slovenian: 6.165 ng·h/ml (CV: 133 %, n = 7), kar je podobno izpostavljenosti, ki so jo opazili pri odraslih bolnikih s PAH, ki so prejemali 125 mg dvakrat dnevno, in upoštevaje razmerje porazdelitve v krvi/plazmi 0,6.
English: In a study investigating the effects of bosentan on testicular function in male PAH patients, 8 out of 24 patients showed a decreased sperm concentration from baseline of at least 42% after 3 or 6 months of treatment with bosentan.
Slovenian: V študiji, ki je preučevala učinke bosentana na funkcijo testisov pri moških bolnikih s PAH, so po 3 ali 6 mesecih zdravljenja z bosentanom pri 8 od 24 bolnikov ugotovili zmanjšano koncentracijo sperme za najmanj 42 % od izhodiščne vrednosti.
English: The same recommendations apply to re-introduction of STAYVEER after treatment interruption (see section
Slovenian: Enaka priporočila veljajo ob ponovni uvedbi zdravila STAYVEER po prekinitvi zdravljenja (glejte poglavje
English: Inhibition by ritonavir of transport protein-mediated uptake into hepatocytes and of CYP3A4, thereby reducing the clearance of bosentan, most likely causes this interaction.
Slovenian: Zaviranje privzema s transportnimi beljakovinami v hepatocite in CYP3A4, ki ga povzroči ritonavir, kar zmanjša očistek bosentana, najverjetneje povzroči to medsebojno delovanje.
English: 3 Headache was reported in 11.5% of patients on bosentan and 9.8% of patients on placebo.
Slovenian: 3 O glavobolu so poročali pri 11,5 % bolnikov na bosentanu in 9,8 % bolnikov na placebu.
English: - The other ingredients in the tablet core are maize starch, pregelatinised starch, sodium starch glycolate (Type A), povidone, glycerol dibehenate and magnesium stearate.
Slovenian: - Druge sestavine v jedru tablete so koruzni škrob, predgelirani škrob, natrijev karboksimetilškrob (vrsta A), povidon, glicerildibehenat in magnezijev stearat.
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).
Slovenian: Odmerjanje bosentana 2 mg/kg trikrat dnevno ni povečalo izpostavljenosti, dnevna izpostavljenost je bila 7.275·ng/ml (CV: 83 %, n = 27).
English: • Anaphylaxis (general allergic reaction), angioedema (swelling, most commonly around the eyes,
Slovenian: • anafilaksa (splošna alergijska reakcija), angioedem (oteklost, običajno okoli oči, ustnic, jezika ali grla)
English: In healthy subjects, bosentan displays dose- and time-dependent pharmacokinetics.
Slovenian: Pri zdravih osebah je farmakokinetika bosentana odvisna od odmerka in časa.
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.
Slovenian: V kombinaciji z zaviralcem CYP3A4 obstaja pri bolnikih, ki slabo presnavljajo s CYP2C9, tveganje še večjega povišanja plazemske koncentracije bosentana, kar lahko povzroči potencialno škodljive neželene dogodke.
English: There is limited clinical study experience with the use of STAYVEER in patients with PAH associated with HIV infection, treated with antiretroviral medicinal products (see section 5.1).
Slovenian: O uporabi zdravila STAYVEER pri bolnikih s PAH, povezanim z okužbo s HIV, ki se zdravijo s protiretrovirusnimi zdravili, imamo omejene izkušnje iz kliničnih študij (glejte poglavje 5.1).
English: Your monthly liver blood test schedule:
Slovenian: Urnik mesečnih preiskav krvi za oceno delovanja jeter:
English: • cyclosporine A (a medicine used after transplants and to treat psoriasis), which must not be used together with STAYVEER.
Slovenian: • ciklosporin A (zdravilo, ki se uporablja po presaditvah in za zdravljenje luskavice), ki ga ne smete uporabljati skupaj z zdravilom STAYVEER,
English: The efficacy of STAYVEER has not been established in patients with severe PAH.
Slovenian: Učinkovitost zdravila STAYVEER pri bolnikih s hudo PAH ni bila ugotovljena.
English: STAYVEER is contraindicated in patients with moderate to severe hepatic impairment, i.e., Child-Pugh class B or C (see section 4.3).
Slovenian: Zdravilo STAYVEER je kontraindicirano pri bolnikih z zmerno do hudo okvaro jeter, tj. razreda B ali C po klasifikaciji Child-Pugh (glejte poglavje 4.3).
English: The co-primary endpoints were percentage change from baseline in pulmonary vascular resistance (PVR) and change from baseline in 6-minute walk distance to Month 6 versus placebo.
Slovenian: Dodatni primarni opazovani dogodki so bile spremembe od izhodiščne vrednosti pri pljučno-žilnem uporu (PŽU) in sprememba prehojene razdalje v 6 minutah hoje od izhodiščne vrednosti do 6. meseca proti placebu.
English: Tell your doctor immediately if you are breast-feeding.
Slovenian: Svojemu zdravniku takoj povejte, če dojite.
English: Elevations to ≥ 8 × ULN were seen in 3.6% of the bosentan-treated patients and 0.4% of the placebo-treated patients.
Slovenian: Zvišanja do ≥ 8 × ZMN so opazili pri 3,6 % bolnikov, ki so jemali bosentan, in 0,4 % bolnikov, ki so prejemali placebo.
English: In adult patients, the exposure to the active metabolite is greater than in healthy subjects.
Slovenian: Odrasli bolniki so bolj izpostavljeni aktivnemu presnovku kot zdrave osebe.
English: Treatment with bosentan resulted in fewer new digital ulcers for the duration of therapy, compared with placebo.
Slovenian: Zdravljenje z bosentanom je v primerjavi s placebom pripeljalo do manj novih razjed prstov med trajanjem terapije.
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.
Slovenian: Za bolnike, ki so se odzvali na zdravljenje, je kasnejša retrospektivna analiza na podlagi spremembe prehojene razdalje, funkcijskega razreda po klasifikaciji SZO in dispneje pri 95 bolnikih, ki so v randomiziranih s placebom nadzorovanih preskušanjih jemali bosentan v odmerku 125 mg dvakrat na dan, pokazala, da je po 8 tednih pri 66 bolnikih prišlo do izboljšanja stanja, pri 22 bolnikih je bilo stanje stabilno, pri 7 bolnikih pa je prišlo do poslabšanja.
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).
Slovenian: V s placebom nadzorovani študiji pri odraslih so poročali o znižanju koncentracije hemoglobina na manj kot 10 g/dl od izhodiščne vrednosti za 8,0 % bolnikov, ki so jemali bosentan, in 3,9 % bolnikov, ki so prejemali placebo (glejte poglavje 4.4).
English: No dose adjustment of STAYVEER is considered necessary.
Slovenian: Prilagoditev odmerka zdravila STAYVEER ni potrebna.
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.
Slovenian: Na podlagi izsledkov študij BREATHE-3, FUTURE 1 in FUTURE-3 kaže, da doseže izpostavljenost bosentanu vrhunec pri pediatričnih bolnikih z nižjimi odmerki kot pri odraslih in da odmerki, višji od 2 mg/kg dvakrat na dan (4 mg/kg dvakrat dnevno ali 2 mg/kg trikrat dnevno) pri pediatričnih bolnikih ne bodo povzročili večje izpostavljenosti bosentanu.
English: • Pulmonary arterial hypertension secondary to scleroderma without significant interstitial pulmonary disease
Slovenian: • pljučni arterijski hipertenziji, ki je posledica skleroderme brez resne intersticijske pljučne bolezni,
English: The most frequent adverse reactions are headache (11.5%), oedema / fluid retention (13.2%), abnormal liver function test (10.9%) and anaemia / haemoglobin decrease (9.9%).
Slovenian: (11,5 %), edem/zastajanje vode (13,2 %), nenormalne vrednosti preiskav delovanja jeter (10,9 %) in anemija/zmanjšanje ravni hemoglobina (9,9 %).
English: STAYVEER is not recommended in paediatric patients with systemic sclerosis and ongoing digital ulcer disease.
Slovenian: Uporaba zdravila STAYVEER se ne priporoča pri pediatričnih bolnikih s sistemsko sklerozo in napredujočo boleznijo razjed prstov.
English: However, STAYVEER can induce hypotension (decrease of your blood pressure) which can make you feel dizzy, affect your vision and affect your ability to drive and use machines.
Slovenian: Zdravilo STAYVEER lahko povzroči hipotenzijo (znižanje krvnega tlaka), zaradi česar ste lahko omotični, ali poslabšanje vida, kar lahko vpliva na vašo sposobnost vožnje ali uporabe strojev.
English: Slightly increased incidence of testicular tubular atrophy was observed in rats given bosentan orally at doses as low as 125 mg/kg/day (about 4 times the maximum recommended human dose [MRHD] and the lowest doses tested) for two years but not at doses as high as 1,500 mg/kg/day (about 50 times the MRHD) for 6 months.
Slovenian: Rahlo povečano pojavnost tubularne atrofije testisov so opazili pri podganah, ki so jim dve leti dajali bosentan peroralno v odmerkih, ki niso presegali 125 mg/kg/dan (približno 4-kratni najvišji priporočeni odmerek pri ljudeh [MRHD] in najnižji preskušani odmerek), ne pa tudi pri tako visokih odmerkih kot je 1500 mg/kg/dan (približno 50-krat MRHD), ki so jih dajali 6 mesecev.
English: The ‘class' reflects the seriousness of the disease: ‘class III' involves marked limitation of physical activity.
Slovenian: ‘Razred' odraža resnost bolezni: ‘III.
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.
Slovenian: Ob naslednjem obisku zdravnika ali ginekologa vzemite to kartico s seboj, da vam bo lahko svetoval/a glede potrebe po dodatni ali drugi kontracepcijski metodi.
English: In the post-marketing period rare cases of liver cirrhosis and liver failure have been reported.
Slovenian: V obdobju trženja so poročali o redkih primerih jetrne ciroze in jetrne odpovedi.
English: STAYVEER contains sodium
Slovenian: STAYVEER vsebuje natrij
English: When administered concomitantly with lopinavir+ritonavir, or other ritonavir-boosted protease inhibitors, the patient's tolerability of STAYVEER should be monitored.
Slovenian: Pri sočasnem dajanju lopinavirja in ritonavirja ali drugih zaviralcev proteaze, ki jih okrepi ritonavir, je treba nadzirati prenašanje zdravila STAYVEER pri bolniku.
English: 2 Hypersensitivity reactions were reported in 9.9% of patients on bosentan and 9.1% of patients on placebo.
Slovenian: 2 O preobčutljivostni reakciji so poročali pri 9,9 % bolnikov na bosentanu in 9,1 % bolnikov na placebu.
English: After a single intravenous dose of 250 mg, the clearance was 8.2 L/h.
Slovenian: Biotransformacija in izločanje Po enkratnem intravenskem odmerku 250 mg je bil očistek 8,2 l/h.
English: Pharmacokinetic data are not available for STAYVEER in young children with this disease.
Slovenian: STAYVEER pri majhnih otrocih s to boleznijo niso na voljo.
English: For white high-density polyethylene bottles, use within 30 days after the first opening.
Slovenian: Vsebino belih plastenk iz polietilena visoke gostote porabite v 30 dneh po prvem odprtju.
English: Treatment with diuretics should be considered in patients with evidence of fluid retention before the start of treatment with STAYVEER.
Slovenian: O zdravljenju z diuretiki razmislimo pri bolnikih z znaki zadrževanja tekočine že pred začetkom zdravljenja z zdravilom STAYVEER.
English: Digoxin: Co-administration for 7 days of bosentan 500 mg twice daily with digoxin decreased the AUC, Cmax and Cmin of digoxin by 12%, 9% and 23%, respectively.
Slovenian: Digoksin: Pri 7-dnevni sočasni uporabi bosentana v odmerku 500 mg dvakrat na dan z digoksinom so se znižale vrednosti AUCτ, Cmax in Cmin digoksina za 12 %, 9 % oziroma 23 %.
English: Of the 7 patients who deteriorated at week 8, 3 improved at week 12/16 and 4 deteriorated compared with baseline.
Slovenian: Od 7 bolnikov s poslabšanjem stanja v 8. tednu se je pri 3 bolnikih stanje izboljšalo v 12./16.
English: An open-label, non-comparative study (AC-052-362 [BREATHE-4]) was performed in 16 patients with WHO functional class III PAH associated with HIV infection.
Slovenian: V odprti, neprimerjalni študiji (AC-052-362 [BREATHE-4]) je sodelovalo šestnajst bolnikov s PAH III. razreda po klasifikaciji SZO, povezanim z okužbo HIV.
English: If the aminotransferase levels return to pre-treatment values continuing or re-introducing STAYVEER according to the conditions described below should be considered.
Slovenian: Če se ravni aminotransferaz vrnejo na vrednosti pred zdravljenjem, je treba presoditi o nadaljevanju ali ponovni uvedbi zdravljenja z zdravilom STAYVEER v skladu s spodaj opisanimi pogoji.
English: Neutropenia, leukopenia1
Slovenian: občasni nevtropenija, levkopenija1
English: Name and address of the manufacturer responsible for batch release
Slovenian: PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov proizvajalca, odgovornega za sproščanje serij
English: Concomitant administration of both a CYP3A4 inhibitor and a CYP2C9 inhibitor with STAYVEER should be avoided (see section 4.5).
Slovenian: Izogibati se moramo sočasni uporabi zaviralcev CYP3A4 in CYP2C9 z zdravilom STAYVEER (glejte poglavje 4.5).
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%).
Slovenian: Pri celotni populaciji (n = 31) z odmerkom 2 mg/kg dvakrat dnevno je bila dnevna izpostavljenost 8.535 ng·h/ml, AUCτ pa 4.268 ng·h/ml (CV: 61 %).
English: In study AC-052-365 (FUTURE 1), dispersible tablets were administered in 36 PAH children aged from 2 to 11 years.
Slovenian: V študiji AC-052-365 (FUTURE 1) je 36 otrok s PAH, starih 2-11 let prejemalo disperzibilne tablete.
English: An interaction study between bosentan and lopinavir+ritonavir in healthy subjects showed increased plasma concentrations of bosentan, with the maximum level during the first 4 days of treatment (see section 4.5).
Slovenian: Študija medsebojnega delovanja med bosentanom in lopinavirjem in ritonavirjem pri zdravih prostovoljcih je pokazala zvišane koncentracije bosentana v plazmi z največjo ravnijo v prvih 4 dneh zdravljenja
English: Consequently, should signs of pulmonary oedema occur when STAYVEER is administered in patients with PAH, the possibility of associated venoocclusive disease should be considered.
Slovenian: Zato moramo v primeru, da se pri bolnikih s PAH, ko prejemajo zdravilo STAYVEER, pojavijo znaki pljučnega edema, pomisliti na možnost sočasne venookluzivne bolezni.
English: The Kaplan-Meier event-free estimate for worsening of PAH (death, lung transplantation, or hospitalisation for PAH worsening) at 24 weeks was 96.9% and 96.7% in the twice daily and three times daily groups, respectively.
Slovenian: Po Kaplan-Meierjevem izračunu je bilo po 24 tednih brez dogodkov poslabšanja PAH (smrt, presaditev pljuč ali hospitalizacija zaradi poslabšanja PAH) 96,9 % bolnikov izmed tistih, ki so prejemali zdravilo dvakrat dnevno, in 96,7 % tistih, ki so prejemali zdravilo trikrat dnevno.
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.
Slovenian: AC-052-355 je bila randomizirana multicentrična dvojno slepa študija, v kateri so s pomočjo vzporedne skupine primerjali bosentan s placebom pri 33 bolnikih s hudo PAH, ki so sočasno prejemali epoprostenol.
English: A volume of distribution (Vss) of about 18 litres was determined after an intravenous dose of 250 mg.
Slovenian: Po intravenskem odmerku 250 mg je bil ugotovljeni volumen porazdelitve (Vss) približno 18 litrov.
English: • Headache • Oedema (swelling of the legs and ankles or other signs of fluid retention)
Slovenian: • edem (otekanje nog in gležnjev in drugi znaki zastajanja tekočine)
English: Because STAYVEER may make hormonal contraception (e.g., oral, injection, implant, or skin patches) ineffective, this method on its own is not reliable.
Slovenian: Ker lahko zdravilo STAYVEER povzroči neučinkovitost hormonske kontracepcije (npr. peroralne oblike, oblike za injiciranje, vsadki ali kožni obliži), ta način sam ni zanesljiv.