FrancophonIA/ELRC3.0 huggingface dataset:
English: Remember to have your liver blood test every month.
Slovenian: Vsak mesec opravite preiskavo krvi za oceno delovanja jeter.
English: Patients and prescribers must be aware that due to potential pharmacokinetic interactions, STAYVEER may render hormonal contraceptives ineffective (see section 4.5).
Slovenian: Bolnica in zdravnik, ki zdravilo predpiše, se morata zavedati, da lahko zaradi možnih farmakokinetičnih interakcij zdravilo STAYVEER povzroči neučinkovitost hormonske kontracepcije
English: A 2-year carcinogenicity study in mice showed an increased combined incidence of hepatocellular adenomas and carcinomas in males, but not in females, at plasma concentrations about 2 to 4 times the plasma concentrations achieved at the therapeutic dose in humans.
Slovenian: 5.3 Predklinični podatki o varnosti Dvoletna študija kancerogenosti pri miših je pokazala povečanje incidence hepatocelularnih adenomov in karcinomov pri samcih, ne pa pri samicah, pri plazemskih koncentracijah, približno 2do 4-krat višjih od plazemskih koncentracij, doseženih pri ljudeh po terapevtskih odmerkih.
English: The dosage of these products may need to be adjusted after initiation, dose change or discontinuation of concomitant STAYVEER treatment.
Slovenian: Morebiti bo po uvedbi zdravljenja, spremembi odmerka ali prekinitvi zdravljenja z zdravilom STAYVEER treba odmerke teh zdravil prilagoditi.
English: • a blood test to check for anaemia (low haemoglobin)
Slovenian: • preiskava krvi za oceno delovanja jeter • preiskava krvi za ugotavljanje slabokrvnosti (nizek hemoglobin)
English: Cartons contain 56 or 112 film-coated tablets.
Slovenian: Škatle vsebujejo 56 ali 112 filmsko obloženih tablet.
English: Skin and subcutaneous disorders Common
Slovenian: Bolezni kože in podkožja pogosti eritem
English: 5 Oedema or fluid retention was reported in 13.2% of patients on bosentan and 10.9% of patients on placebo.
Slovenian: 5 O edemu ali zastajanju tekočine so poročali pri 13,2 % bolnikov na bosentanu in pri 10,9 %
English: Caution is recommended in the case of co-administration.
Slovenian: V primeru sočasnega dajanja je potrebna previdnost.
English: STAYVEER 125 mg film-coated tablets PVC/PE/PVDC/aluminium-blisters containing 14 film-coated tablets.
Slovenian: STAYVEER 125 mg filmsko obložene tablete Pretisni omot iz PVC/PE/PVDC/aluminija s 14 filmsko obloženimi tabletami.
English: CARTON WITH 56 TABLETS
Slovenian: ŠKATLA S 56 TABLETAMI
English: • Cirrhosis (scarring) of the liver, liver failure (serious disturbance of liver function)
Slovenian: • ciroza (brazgotinjenje) jeter, odpoved jeter (huda motnja delovanja jeter)
English: Rifampicin: Co-administration in 9 healthy subjects for 7 days of bosentan 125 mg twice daily with rifampicin, a potent inducer of CYP2C9 and CYP3A4, decreased the plasma concentrations of bosentan by 58%, and this decrease could achieve almost 90% in an individual case.
Slovenian: Rifampicin: 7-dnevno sočasno dajanje bosentana 125 mg dvakrat na dan in rifampicina, močnega induktorja CYP2C9 in CYP3A4, 9 zdravim osebam je zmanjšalo plazemske koncentracije bosentana za 58 %, v enem primeru je to zmanjšanje doseglo 90 %.
English: OUTER CARTON & BOTTLE LABEL/ BOTTLES
Slovenian: NALEPKA ZUNANJE ŠKATLE IN PLASTENKE/ PLASTENKE
English: Cases of pulmonary oedema have been reported with vasodilators (mainly prostacyclins) when used in patients with pulmonary veno-occlusive disease.
Slovenian: Pri uporabi vazodilatatorjev (zlasti prostaciklinov) pri bolnikih s pljučno venookluzivno boleznijo so poročali o primerih pljučnega edema.
English: Fertility
Slovenian: etilceluloza
English: Intensified monitoring is recommended during the discontinuation period.
Slovenian: V obdobju nižanja odmerka zdravila priporočamo skrbnejše spremljanje.
English: Study AC-052-356 (BREATHE-3) evaluated the pharmacokinetics of single and multiple oral doses of the film-coated tablet formulation of bosentan in 19 children aged from 3 to 15 years with PAH who were dosed on the basis of body weight with 2 mg/kg twice daily.
Slovenian: V študiji AC-052-356 (BREATHE-3) so ocenjevali farmakokinetiko enkratnega in večkratnih peroralnih odmerkov bosentana v obliki filmsko obloženih tablet pri 19 otrocih, starih od 3 do 15 let, s
English: No dose adjustment is needed in patients with mild hepatic impairment (i.e., Child-Pugh class A) (see section 5.2).
Slovenian: Prilagajanje odmerka pri bolnikih z blago okvarjenim delovanjem jeter (po klasifikaciji Child-Pugh razred A) ni potrebno (glejte poglavje 5.2).
English: In a prospective, multi-centre, randomised, double-blind, placebo-controlled study (AC-052-405 [BREATHE-5]), patients with PAH WHO functional class III and Eisenmenger physiology associated with congenital heart disease received bosentan 62.5 mg twice daily for 4 weeks, then 125 mg twice daily for a further 12 weeks (n = 37, of whom 31 had a predominantly right to left, bidirectional shunt).
Slovenian: 405 [BREATHE-5]) so bolniki s PAH III. razreda po klasifikaciji SZO in Eisenmengerjevo fiziologijo, povezano s kongenitalno srčno boleznijo, 4 tedne prejemali bosentan 2,5 mg dvakrat na dan, nato pa nadaljnjih 12 tednov 125 mg dvakrat na dan (n = 37, med katerimi jih je imelo 31 pretežno desno-levi dvosmerni šant).
English: STAYVEER 125 mg film-coated tablets are orange-white, oval film-coated tablets with “125” on one side.
Slovenian: STAYVEER 125 mg filmsko obložene tablete so oranžno-bele ovalne filmsko obložene tablete z napisom „125“ na eni strani.
English: After 4 weeks of bosentan 62.5 mg twice daily, the maintenance dose studied in both these studies was 125 mg twice daily.
Slovenian: 4 tednih jemanja bosentana v odmerku 62,5 mg dvakrat na dan je bil vzdrževalni odmerek, preučevan v teh študijah, 125 mg dvakrat na dan.
English: There was evidence of a mild thyroid hormonal imbalance induced by bosentan in rats.
Slovenian: Pri podganah so dokazali, da bosentan povzroča blago hormonsko neravnovesje v ščitnici.
English: In this study there was an increasedincidence of hospitalisation due to CHF during the first 4-8 weeks of treatment with bosentan, which could have been the result of fluid retention.
Slovenian: V tej študiji je bilo število primerov hospitalizacije zaradi CHF v prvih 4-8
English: The mean increase from baseline in cardiac index was 0.5 L/min/m2, the mean decrease in mean pulmonary arterial pressure was 8 mmHg, and the mean decrease in PVR was 389 dyn·sec·cm-5.
Slovenian: Povprečno povečanje srčnega indeksa od izhodiščne vrednosti je bilo 0,5 l/min/m2, povprečno znižanje povprečnega pljučnega arterijskega tlaka je bilo
English: • Pulmonary arterial hypertension associated with congenital systemic-to-pulmonary shunts and
Slovenian: • pljučni arterijski hipertenziji, povezani s kongenitalnimi sistemsko-pulmonalnimi šanti in Eisenmengerjevo fiziologijo.
English: Recommended dose Adult
Slovenian: Priporočeni odmerek
English: In addition, an increased incidence of elevated aminotransferases was observed in patients receiving concomitant therapy.
Slovenian: Poleg tega so pri bolnikih, ki so sočasno jemali obe zdravili, opazili povečanje incidence povišanih koncentracij aminotransferaz.
English: Nasal congestion1
Slovenian: občasni trombocitopenija1
English: Pharmacokinetics were studied in paediatric patients in 4 clinical studies (BREATHE-3, FUTURE 1, FUTURE-3 and FUTURE-4; see section 5.1).
Slovenian: Farmakokinetiko pri pediatričnih bolnikih so preučevali v 4 kliničnih študijah (BREATHE-3,
English: Bosentan is metabolised by CYP2C9 and CYP3A4.
Slovenian: Bosentan presnavljata CYP2C9 in CYP3A4.
English: When co-administered, initial trough concentrations of bosentan were approximately 30-fold higher than those measured after bosentan alone.
Slovenian: Kadar so ju uporabljali sočasno, so bile ob začetku odmerjanja koncentracije bosentana tik pred naslednjim odmerkom približno 30-krat višje kot koncentracije,
English: Glibenclamide: Co-administration of bosentan 125 mg twice daily for 5 days decreased the plasma concentrations of glibenclamide (a CYP3A4 substrate) by 40%, with potential significant decrease of the hypoglycaemic effect.
Slovenian: Glibenklamid: Pri sočasni uporabi bosentana v odmerku 125 mg dvakrat na dan 5 dni se je plazemska koncentracija glibenklamida (substrat CYP3A4) znižala za 40 % in potencialno pomembno zmanjšala hipoglikemični učinek.
English: How to take STAYVEER.
Slovenian: Kako jemati zdravilo STAYVEER
English: These haemodynamic improvements from baseline were similar with or without co-administration of epoprostenol.
Slovenian: Ta izboljšanja hemodinamskih kazalcev glede na izhodiščno vrednost so bila podobna, ne glede na to, ali so bolniki sočasno prejemali epoprostenol ali ne.
English: After 4 weeks of bosentan 62.5 mg twice daily, the maintenance doses studied in these studies were 125 mg twice daily in AC-052-351, and 125 mg twice daily and 250 mg twice daily in AC-052-352.
Slovenian: 125 mg dvakrat na dan v AC-052-351 ter odmerek 125 mg dvakrat na dan in 250 mg dvakrat na dan v AC-052-352.
English: The NOAEL was 21 times (at Day 21 post partum) and 2.3 times (Day 69 post partum) the human therapeutic exposure, respectively.
Slovenian: Raven brez neželenih učinkov (NOAEL) je bila na 21. dan po skotitvi 21-krat višja, na 69. dan po skotitvi pa 2,3-krat višja od terapevtske izpostavljenosti pri ljudeh.
English: Data on other CYP3A4 inducers, e.g., carbamazepine, phenobarbital, phenytoin and St. John's wort are lacking, but their concomitant administration is expected to lead to reduced systemic exposure to bosentan.
Slovenian: fenobarbitalu, fenitoinu in šentjanževki, so pomanjkljivi, pričakujemo pa, da njihovo sočasno dajanje povzroči zmanjšano sistemsko izpostavljenost bosentanu.
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.
Slovenian: Srednja vrednost AUCτ (CV %) bosentana pri pediatričnih bolnikih, ki so prejemali 31,25 mg bosentana dvakrat na dan, je bila 3.496 (49) ng·h/ml, pri 62,5 mg dvakrat na dan 5.428 (79) ng·h/ml ter pri 125 mg dvakrat na dan 6.124 (27) ng·h/ml.
English: The safety profile in the first paediatric uncontrolled study performed with the film-coated tablet (BREATHE-3: n = 19, median age 10 years [range 3-15 years], open-label bosentan 2 mg/kg twice daily; treatment duration 12 weeks) was similar to that observed in the pivotal trials in adult patients with PAH.
Slovenian: 3: n = 19, mediana starosti 10 let [razpon 3-15 let], odprta študija z bosentanom 2 mg/kg dvakrat na dan; trajanje zdravljenja 12 tednov) je bil podoben kot v ključnih študijah pri odraslih bolnikih s PAH.
English: ((Back cover))
Slovenian: ((Zadnja stran))
English: Aminotransferase elevations associated with hepatitis (including possible exacerbation of underlying hepatitis) and/or jaundice1 (see section 4.4)
Slovenian: (vključno z možnim poslabšanjem osnovnega hepatitisa) in/ali zlatenico1 (glejte poglavje 4.4)
English: No dose adjustment is needed for warfarin and similar oral anticoagulant agents when bosentan is initiated, but intensified monitoring of INR is recommended, especially during bosentan initiation and the up-titration period.
Slovenian: Za varfarin in podobne peroralne antikoagulante ob začetku zdravljenja z bosentanom prilagajanje odmerka ni potrebno, priporočamo pa pogostejše spremljanje
English: Blood tests for liver function
Slovenian: Krvne preiskave za delovanje jeter
English: • a pregnancy test if you are a woman of childbearing potential
Slovenian: • testi nosečnosti za ženske v rodni dobi
English: No dose adjustment is required in patients with renal impairment.
Slovenian: Prilaganje odmerka pri bolnikih z okvarjenim delovanjem ledvic ni potrebno.
English: There is limited experience with abrupt discontinuation of STAYVEER in patients with PAH.
Slovenian: Z nenadno prekinitvijo zdravljenja z zdravilom STAYVEER pri bolnikih s PAH je le malo izkušenj.
English: There was no relevant difference in adverse event frequencies between patients above and below the age of 2 years; however, this is based on only 21 children less than 2 years, including 6 patients between 3 months to 1 year of age.
Slovenian: vendar ta ugotovitev temelji le na 21 bolnikih, mlajših od 2 let, vključno s 6 bolniki, starimi od 3
English: Systemic sclerosis with digital ulcer disease
Slovenian: Sistemska skleroza z boleznijo razjed prstov
English: Simvastatin: Co-administration of bosentan 125 mg twice daily for 5 days decreased the plasma concentrations of simvastatin (a CYP3A4 substrate) and its active β-hydroxy acid metabolite by 34% and 46%, respectively.
Slovenian: Simvastatin: Pri sočasni uporabi bosentana v odmerku 125 mg dvakrat na dan 5 dni se je plazemska koncentracija simvastatina (substrat CYP3A4) znižala za 34 %, plazemska koncentracija njegovega aktivnega presnovka beta-hidroksi kisline pa za 46 %.
English: Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172) Ethylcellulose
Slovenian: Filmska obloga: hipromeloza gliceriltriacetat smukec titanov dioksid (E171) rumeni železov oksid (E172)
English: STAYVEER 62.5 mg film-coated tablets STAYVEER 125 mg film-coated tablets
Slovenian: STAYVEER 62,5 mg filmsko obložene tablete STAYVEER 125 mg filmsko obložene tablete
English: • Some patients taking STAYVEER have been found to have abnormal liver function tests and anaemia (low haemoglobin).
Slovenian: Pri nekaterih bolnikih, ki so uporabljali zdravilo STAYVEER, so ugotovili nenormalne vrednosti testov delovanja jeter in anemijo (nizek hemoglobin).
English: Epoprostenol: Limited data obtained from a study (AC-052-356 [BREATHE-3]) in which 10 paediatric patients received the combination of bosentan and epoprostenol indicate that after both single- and multiple-dose administration, the Cmax and AUC values of bosentan were similar in patients with or without continuous infusion of epoprostenol (see section 5.1).
Slovenian: pediatričnih bolnikov prejemalo kombinacijo bosentana in epoprostenola, kažejo, da sta bili, tako po enkratnem kot tudi po večkratnem odmerjanju, vrednosti Cmax in AUCτ za bosentan podobni pri bolnikih s kontinuirano infuzijo epoprostenola ali brez nje (glejte poglavje 5.1).
English: Bosentan has been administered as a single dose of up to 2,400 mg to healthy subjects and up to 2,000 mg/day for 2 months in patients with a disease other than pulmonary hypertension.
Slovenian: Bosentan so dajali v enkratnem odmerku do 2.400 mg zdravim osebam in do 2.000 mg na dan
English: The plasma concentrations of bosentan were not affected by concomitant simvastatin.
Slovenian: Sočasna uporaba simvastatina ni vplivala na plazemske koncentracije bosentana.
English: At the end of this study, there was no difference in overall hospitalisations for heart failure nor in mortality between bosentan- and placebo-treated patients.
Slovenian: ki so jemali bosentan, in bolniki, ki so prejemali placebo, ni bilo razlike niti v skupnem številu hospitalizacij zaradi srčnega popuščanja niti v umrljivosti.
English: Warfarin: Co-administration of bosentan 500 mg twice daily for 6 days decreased the plasma concentrations of both S-warfarin (a CYP2C9 substrate) and R-warfarin (a CYP3A4 substrate) by 29% and 38%, respectively.
Slovenian: Varfarin: Pri sočasni uporabi bosentana v odmerku 500 mg dvakrat na dan 6 dni se je plazemska koncentracija S-varfarina (substrat CYP2C9) znižala za 29 % in plazemska koncentracija R-varfarina
English: The most serious side effects with STAYVEER are
Slovenian: Najpogostejši neželeni učinki pri uporabi zdravila STAYVEER so:
English: In adult patients, STAYVEER treatment should be initiated at a dose of 62.5 mg twice daily for 4 weeks and then increased to the maintenance dose of 125 mg twice daily.
Slovenian: Pri odraslih bolnikih začnemo zdravljenje z zdravilom STAYVEER z odmerkom 62,5 mg dvakrat na dan štiri tedne, nato pa odmerek povišamo na vzdrževalnega 125 mg dvakrat na dan.
English: At steady state, the systemic exposures in paediatric patients weighing 10-20 kg, 20-40 kg and > 40 kg were 43%, 67% and 75%, respectively, of the adult systemic exposure.
Slovenian: Te vrednosti so bile nižje kot vrednost 8.149 (47) ng·h/ml, izmerjena pri odraslih bolnikih s PAH, ki so jemali 125 mg dvakrat na dan. Sistemska izpostavljenost pri pediatričnih bolnikih, ki so tehtali 10-20 kg, 20-40 kg in > 40 kg, je bila v stanju dinamičnega ravnovesja 43 %, 67 % oziroma 75 % sistemske izpostavljenosti pri odraslih.
English: Patients were in WHO functional class I (n = 19, 29 %), class II (n = 27, 42%) or class III (n = 18, 28%) at start of study treatment.
Slovenian: razredu (n = 27, 42 %) ali III. razredu (n = 18, 28 %).
English: The number of new digital ulcers from baseline to study endpoint was a primary endpoint in both studies.
Slovenian: Primarni opazovani dogodek obeh študij je bila število novih razjed prstov od izhodišča do konca študije.
English: Adverse reactions observed in 20 placebo-controlled studies and post-marketing experience with bosentan are ranked according to frequency using the following convention: very common (≥ 1/10); common (≥1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Slovenian: (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki
English: Cartons contain 56 film-coated tablets.
Slovenian: Škatle, ki vsebujejo 56 filmsko obloženih tablet.
English: Treatment with bosentan was associated with a significant reduction in the rate of clinical worsening compared with placebo at 28 weeks (10.7% vs 37.1%, respectively; p = 0.0015).
Slovenian: (10,7 % pri bosentanu proti 37,1 % pri placebu, p = 0,0015).
English: STAYVEER 62.5 mg film-coated tablets are orange-white, round film-coated tablets with “62,5” on one side.
Slovenian: STAYVEER 62,5 mg filmsko obložene tablete so oranžno-bele okrogle filmsko obložene tablete z napisom „62,5“ na eni strani.
English: STAYVEER 125 mg tablets bosentan
Slovenian: STAYVEER 125 mg tablete bosentan
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]).
Slovenian: Je pa v s placebom nadzorovani študiji (študija AC-052-301/302 [ENABLE 1 & 2]) s povprečnim trajanjem zdravljenja 1,5 let sodelovalo 1611 bolnikov (804 bolniki so jemali bosentan, 807 bolnikov je prejemalo placebo) s hudim kroničnim srčnim popuščanjem (CHF
English: No evidence for acute rebound has been observed.
Slovenian: Kakih znakov ponovnega pojava akutnega bolezenskega stanja niso opažali.
English: - STAYVEER 125 mg film-coated tablets: The active substance is bosentan as monohydrate.
Slovenian: - STAYVEER 125 mg filmsko obložene tablete: učinkovina je bosentan v obliki monohidrata.
English: STAYVEER 62.5 mg tablets bosentan
Slovenian: STAYVEER 62,5 mg tablete bosentan
English: STAYVEER is contraindicated in pregnancy (see section 4.3).
Slovenian: STAYVEER (glejte poglavje 4.4).
English: Transfer to a therapy that is recommended at the severe stage of the disease (e.g., epoprostenol) should be considered if the clinical condition deteriorates (see section 4.2).
Slovenian: Če pride do poslabšanja kliničnega stanja (glejte poglavje 4.2), premislite o prevedbi na zdravljenje, priporočeno za hudo obliko bolezni (denimo, epoprostenol).
English: - STAYVEER 62.5 mg film-coated tablets: The active substance is bosentan as monohydrate.
Slovenian: - STAYVEER 62,5 mg filmsko obložene tablete: učinkovina je bosentan v obliki monohidrata.
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.
Slovenian: 125 mg dvakrat na dan skupaj z lopinavirjem 400 mg, ter ritonavirjem 100 mg dvakrat na dan, ki je trajalo 9,5 dni, je pri zdravih prostovoljcih na začetku odmerjanja povzročilo koncentracije bosentana v plazmi tik pred naslednjim odmerkom, ki so bile približno 48-krat višje od koncentracij, izmerjenih pri zdravljenju samo z bosentanom.
English: • if you are allergic to bosentan or any of the other ingredients of this medicine (listed in section 6)
Slovenian: • če ste alergični na bosentan ali katero koli sestavino tablet (navedeno v poglavju 6), • če imate težave z jetri (vprašajte zdravnika),
English: STAYVEER 62.5 mg film-coated tablets Each film-coated tablet contains 62.5 mg bosentan (as monohydrate).
Slovenian: STAYVEER 62,5 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 62,5 mg bosentana v obliki bosentana monohidrata.
English: Treatment and monitoring recommendations
Slovenian: OZNAČEVANJE IN NAVODILO ZA UPORABO
English: In study AC-052-401, during 16 weeks of double-blind therapy, patients in the bosentan group developed a mean of 1.4 new digital ulcers vs 2.7 new digital ulcers in the placebo group (p = 0.0042).
Slovenian: 16-tedensko dvojno slepo terapijo razvili povprečno 1,4 nove razjede na prstih nasproti 2,7 novim razjedam v skupini, zdravljeni s placebom (p = 0,0042).
English: Monthly pregnancy tests are recommended while you are taking STAYVEER and are of childbearing age.
Slovenian: V času jemanja zdravila STAYVEER se priporočajo mesečni testi nosečnosti, če ste v rodni dobi.
English: STAYVEER treatment should be initiated at a dose of 62.5 mg twice daily for 4 weeks and then increased to the maintenance dose of 125 mg twice daily.
Slovenian: Zdravljenje z zdravilom STAYVEER začnemo z odmerkom 62,5 mg dvakrat na dan štiri tedne, nato pa odmerek povišamo na vzdrževalnega 125 mg dvakrat na dan.
English: Patients were treated with bosentan 62.5 mg twice daily for 4 weeks followed by 125 mg twice daily for a further 12 weeks.
Slovenian: Štiri tedne so prejemali bosentan 62,5 mg dvakrat na dan, nato pa nadaljnjih 12 tednov 125 mg dvakrat na dan.
English: Palpitations1, 4
Slovenian: Srčne bolezni pogosti palpitacije1, 4
English: Consequently, plasma concentrations of substances metabolised by these isoenzymes will be decreased when STAYVEER is co-administered.
Slovenian: Zaradi tega se ob sočasni uporabi zdravila STAYVEER v plazmi znižajo koncentracije snovi, ki jih presnavljajo ti izoencimi.
English: In PAH and heart failure, in the absence of endothelin receptor antagonism, elevated ET-1 concentrations are strongly correlated with the severity and prognosis of these diseases.
Slovenian: so povišane koncentracije ET-1 močno povezane z resnostjo in prognozo teh bolezni.
English: STAYVEER 125 mg film-coated tablets Each film-coated tablet contains 125 mg bosentan (as monohydrate).
Slovenian: STAYVEER 125 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 125 mg bosentana v obliki bosentana monohidrata.
English: Change from BL; mean (SD)
Slovenian: srednja vrednost (SD) Sprememba od IV;
English: Treatment should only be initiated and monitored by a physician experienced in the treatment of systemic sclerosis.
Slovenian: Sistemska skleroza z nastajajočimi razjedami prstov Zdravljenje naj začne in vodi zdravnik z izkušnjami z zdravljenjem sistemske skleroze.
English: In fertility studies in male and female rats, no effects on sperm count, motility and viability, or on mating performance or fertility were observed at exposures that were 21 and 43 times the expected therapeutic level in humans, respectively; nor was there any adverse effect on the development of the pre-implantation embryo or on implantation.
Slovenian: 21-krat in 43-krat višje od pričakovane terapevtske ravni pri ljudeh, niti ni bilo nobenega neželenega učinka na razvoj zarodka pred ugnezditvijo ali na ugnezditev samo.
English: • The median time to complete weaning from iNO was 3.7 days (95% confidence limits [CLs] 1.17, 6.95) on bosentan and 2.9 days (95% CLs 1.26, 4.23) on placebo (p = 0.34).
Slovenian: 1,17, 6,95), pri placebu pa 2,9 dni (95-% meje zaupanja [MZ] 1,26; 4,23) (p = 0,34).