natgillin/translations-raw huggingface dataset:
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.
fenobarbitalu, fenitoinu in šentjanževki, so pomanjkljivi, pričakujemo pa, da njihovo sočasno dajanje povzroči zmanjšano sistemsko izpostavljenost bosentanu.
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.
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.
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.
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.
((Back cover))
((Zadnja stran))
Aminotransferase elevations associated with hepatitis (including possible exacerbation of underlying hepatitis) and/or jaundice1 (see section 4.4)
(vključno z možnim poslabšanjem osnovnega hepatitisa) in/ali zlatenico1 (glejte poglavje 4.4)
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.
Za varfarin in podobne peroralne antikoagulante ob začetku zdravljenja z bosentanom prilagajanje odmerka ni potrebno, priporočamo pa pogostejše spremljanje
Blood tests for liver function
Krvne preiskave za delovanje jeter
• a pregnancy test if you are a woman of childbearing potential
• testi nosečnosti za ženske v rodni dobi
No dose adjustment is required in patients with renal impairment.
Prilaganje odmerka pri bolnikih z okvarjenim delovanjem ledvic ni potrebno.
There is limited experience with abrupt discontinuation of STAYVEER in patients with PAH.
Z nenadno prekinitvijo zdravljenja z zdravilom STAYVEER pri bolnikih s PAH je le malo izkušenj.
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.
vendar ta ugotovitev temelji le na 21 bolnikih, mlajših od 2 let, vključno s 6 bolniki, starimi od 3
Systemic sclerosis with digital ulcer disease
Sistemska skleroza z boleznijo razjed prstov
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.
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 %.
Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172) Ethylcellulose
Filmska obloga: hipromeloza gliceriltriacetat smukec titanov dioksid (E171) rumeni železov oksid (E172)
STAYVEER 62.5 mg film-coated tablets STAYVEER 125 mg film-coated tablets
STAYVEER 62,5 mg filmsko obložene tablete STAYVEER 125 mg filmsko obložene tablete
• Some patients taking STAYVEER have been found to have abnormal liver function tests and anaemia (low haemoglobin).
Pri nekaterih bolnikih, ki so uporabljali zdravilo STAYVEER, so ugotovili nenormalne vrednosti testov delovanja jeter in anemijo (nizek hemoglobin).
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).
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).
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.
Bosentan so dajali v enkratnem odmerku do 2.400 mg zdravim osebam in do 2.000 mg na dan
The plasma concentrations of bosentan were not affected by concomitant simvastatin.
Sočasna uporaba simvastatina ni vplivala na plazemske koncentracije bosentana.
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.
ki so jemali bosentan, in bolniki, ki so prejemali placebo, ni bilo razlike niti v skupnem številu hospitalizacij zaradi srčnega popuščanja niti v umrljivosti.
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.
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
The most serious side effects with STAYVEER are
Najpogostejši neželeni učinki pri uporabi zdravila STAYVEER so:
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.
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.
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.
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.
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.
razredu (n = 27, 42 %) ali III. razredu (n = 18, 28 %).
The number of new digital ulcers from baseline to study endpoint was a primary endpoint in both studies.
Primarni opazovani dogodek obeh študij je bila število novih razjed prstov od izhodišča do konca študije.
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).
(≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki
Cartons contain 56 film-coated tablets.
Škatle, ki vsebujejo 56 filmsko obloženih tablet.
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).
(10,7 % pri bosentanu proti 37,1 % pri placebu, p = 0,0015).
STAYVEER 62.5 mg film-coated tablets are orange-white, round film-coated tablets with “62,5” on one side.
STAYVEER 62,5 mg filmsko obložene tablete so oranžno-bele okrogle filmsko obložene tablete z napisom „62,5“ na eni strani.
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]).
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
No evidence for acute rebound has been observed.
Kakih znakov ponovnega pojava akutnega bolezenskega stanja niso opažali.
- STAYVEER 125 mg film-coated tablets: The active substance is bosentan as monohydrate.
- STAYVEER 125 mg filmsko obložene tablete: učinkovina je bosentan v obliki monohidrata.
STAYVEER is contraindicated in pregnancy (see section 4.3).
STAYVEER (glejte poglavje 4.4).
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).
Če pride do poslabšanja kliničnega stanja (glejte poglavje 4.2), premislite o prevedbi na zdravljenje, priporočeno za hudo obliko bolezni (denimo, epoprostenol).
- STAYVEER 62.5 mg film-coated tablets: The active substance is bosentan as monohydrate.
- STAYVEER 62,5 mg filmsko obložene tablete: učinkovina je bosentan v obliki monohidrata.
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.
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.
• if you are allergic to bosentan or any of the other ingredients of this medicine (listed in section 6)
• če ste alergični na bosentan ali katero koli sestavino tablet (navedeno v poglavju 6), • če imate težave z jetri (vprašajte zdravnika),
STAYVEER 62.5 mg film-coated tablets Each film-coated tablet contains 62.5 mg bosentan (as monohydrate).
STAYVEER 62,5 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 62,5 mg bosentana v obliki bosentana monohidrata.
Treatment and monitoring recommendations
OZNAČEVANJE IN NAVODILO ZA UPORABO
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).
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).
Monthly pregnancy tests are recommended while you are taking STAYVEER and are of childbearing age.
V času jemanja zdravila STAYVEER se priporočajo mesečni testi nosečnosti, če ste v rodni dobi.
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.
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.
Patients were treated with bosentan 62.5 mg twice daily for 4 weeks followed by 125 mg twice daily for a further 12 weeks.
Štiri tedne so prejemali bosentan 62,5 mg dvakrat na dan, nato pa nadaljnjih 12 tednov 125 mg dvakrat na dan.
Palpitations1, 4
Srčne bolezni pogosti palpitacije1, 4
Consequently, plasma concentrations of substances metabolised by these isoenzymes will be decreased when STAYVEER is co-administered.
Zaradi tega se ob sočasni uporabi zdravila STAYVEER v plazmi znižajo koncentracije snovi, ki jih presnavljajo ti izoencimi.
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.
so povišane koncentracije ET-1 močno povezane z resnostjo in prognozo teh bolezni.
STAYVEER 125 mg film-coated tablets Each film-coated tablet contains 125 mg bosentan (as monohydrate).
STAYVEER 125 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 125 mg bosentana v obliki bosentana monohidrata.
Change from BL; mean (SD)
srednja vrednost (SD) Sprememba od IV;
Treatment should only be initiated and monitored by a physician experienced in the treatment of systemic sclerosis.
Sistemska skleroza z nastajajočimi razjedami prstov Zdravljenje naj začne in vodi zdravnik z izkušnjami z zdravljenjem sistemske skleroze.
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.
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.
• 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).
1,17, 6,95), pri placebu pa 2,9 dni (95-% meje zaupanja [MZ] 1,26; 4,23) (p = 0,34).
Blood Test for Liver Function
Preiskave krvi za oceno delovanja jeter
In the patients with Child-Pugh class B liver impairment, the mean (95% CI) steady-state AUC of bosentan was 360 (212613) ng⋅h/mL, i.e., 4.7 times higher, and the mean (95% CI) AUC of the active metabolite Ro 48-5033 was 106 (58.4-192) ng⋅h/mL, i.e., 12.4 times higher than in the patients with normal liver function (bosentan: mean [95% CI] AUC: 76.1 [9.07-638] ng⋅h/mL; Ro 48-5033: mean [95% CI] AUC 8.57 [1.28-57.2] ng⋅h/ml).
(95-% IZ) AUCτ v stanju dinamičnega ravnovesja za bosentan 360 (212-613) ng·h/ml, tj., 4,7-krat višji, povprečni (95-% IZ) AUCτ aktivnega presnovka Ro 48-5033 pa je bil 106 (58,4-192) ng·h/ml,
Cartons contain 56 film-coated tablets (STAYVEER 125 mg film-coated tablets).
Škatle vsebujejo 56 filmsko obloženih tablet (zdravilo STAYVEER 125 mg filmsko obložene tablete).
Inside your pack of STAYVEER tablets you will find a Patient Alert Card which you should read carefully.
Znotraj škatle s tabletami STAYVEER je Opozorilna kartica za bolnika.
Pulmonary arterial hypertension
• Pljučne arterijske hipertenzije (PAH).
What STAYVEER looks like and contents of the pack
Izgled zdravila STAYVEER in vsebina pakiranja
Concomitant use of STAYVEER and cyclosporine A is contraindicated (see sections 4.3 and 4.5).
Sočasna uporaba zdravila STAYVEER in ciklosporina A je kontraindicirana (glejte poglavji 4.3 in
Each tablet contains 62.5 mg of bosentan (as monohydrate).
Ena tableta vsebuje 62,5 mg bosentana (v obliki monohidrata).
Safety and tolerability of bosentan was investigated in an exploratory, uncontrolled 12-week study in 11 patients with pulmonary hypertension secondary to severe COPD (stage III of GOLD classification).
Varnost in prenašanje bosentana so raziskali v raziskovalni, nekontrolirani 12-tedenski študiji z 11
Kaplan-Meier estimates of survival were 90% and 85% at 3 and 4 years after the start of treatment, respectively.
Ocena preživetja po metodi Kaplan-Meier je bila 90 % 3 leta in
Each tablet contains 125 mg of bosentan (as monohydrate).
Ena tableta vsebuje 125 mg bosentana (v obliki monohidrata).
After oral administration, the systemic exposure is proportional to dose up to 500 mg. At higher oral doses, Cmax and AUC increase less than proportionally to the dose.
Pri višjih peroralnih odmerkih se Cmax in AUCτ povečujeta manj kot bi bilo sorazmerno odmerku.
Very common (may affect more than one in 10 people):
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): • glavobol
Bosentan
Dojenje
• Thrombocytopenia (low number of blood platelets)
• trombocitopenija (nizko število trombocitov)
Liver cirrhosis, liver failure1
redki ciroza jeter, jetrna odpoved1
Twenty-six patients continued to receive bosentan in the 24-week open-label extension phase (AC-052-409) of the BREATHE-5 study (mean duration of treatment = 24.4 ± 2.0 weeks) and, in general, efficacy was maintained.
V fazi odprtega podaljška je šestindvajset bolnikov še naprej prejemalo bosentan v nadaljnjem 24-tedenskem obdobju zdravljenja (AC-052-409) študije
No dose proportionality was observed, as steady-state bosentan plasma concentrations and AUCs were similar at oral doses of 2 and 4 mg/kg (AUCτ: 3,577 ng·h/mL and 3,371 ng·h/mL for 2 mg/kg twice daily and 4 mg/kg twice daily, respectively).
Sorazmernosti odmerka niso opazili, saj so bile koncentracije bosentana v plazmi v stanju dinamičnega ravnovesja in AUCτ pri peroralnih odmerkih 2 in 4 mg/kg podobne (AUCτ:
In a randomised, double-blind, multi-centre, placebo-controlled study (AC-052-364 [EARLY]), 185 PAH patients in WHO functional class II (mean baseline 6-minute walk distance of 435 metres) received bosentan 62.5 mg twice daily for 4 weeks followed by 125 mg twice daily (n = 93), or placebo (n = 92) for 6 months.
funkcijskega razreda po SZO (srednja izhodiščna vrednost 435 metrov prehojenih v 6 minutah) prejemalo bosentan 62,5 mg dvakrat na dan 4 tedne in nato 125 mg dvakrat na teden (n = 93), ali placebo (n = 92) 6 mesecev.
Cartons contain 56 or 112 film coated tablets (STAYVEER 125 mg film-coated tablets).
56 ali 112 filmsko obloženih tablet (STAYVEER 125 mg filmsko obložene tablete).
STAYVEER 125 mg film-coated tablets bosentan
STAYVEER 125 mg filmsko obložene tablete bosentan
Bosentan is an inducer of the cytochrome P450 (CYP) isoenzymes CYP2C9 and CYP3A4.
Bosentan je induktor izoencimov CYP2C9 in CYP3A4 citokroma P450 (CYP).
If the aminotransferase levels return to pre-treatment values reintroducing STAYVEER according to the conditions described below should be considered.
je treba presoditi o ponovni uvedbi zdravljenja z zdravilom STAYVEER v skladu s spodaj opisanimi pogoji.
Therefore, hormonebased contraceptives alone, regardless of the route of administration (i.e., oral, injectable, transdermal or implantable forms), are not considered as reliable methods of contraception (see sections 4.4 and
Zato kontracepcija, ki temelji samo na hormonih, ni zanesljiv način kontracepcije, ne glede na način apliciranja (npr. peroralno, parenteralno,
Cartons contain 56 or 112 film coated tablets (STAYVEER 62.5 mg film-coated tablets).
56 ali 112 filmsko obloženih tablet (STAYVEER 62,5 mg filmsko obložene tablete).
• flu-like syndrome (joint and muscle pain with fever)
• letargijo ali utrujenost (nenavadna utrujenost ali izčrpanost) • gripi podobni sindromi (bolečine sklepov in mišic z zvišano telesno temperaturo)
BREATHE-3 (AC-052-356)
in AC-052-356 (BREATHE-3).
In a randomised placebo-controlled study, conducted in PPHN patients (FUTURE-4), a total of 13 neonates were treated with the bosentan dispersible tablet formulation at a dose of 2 mg/kg twice daily (8 patients were on placebo).
13 novorojenčkov zdravljenih z bosentanom v obliki disperzibilnih tablet v odmerku 2 mg/kg dvakrat dnevno (8 bolnikov je dobivalo placebo).
Treatment with STAYVEER should only be started and monitored by a doctor who has experience in the treatment of PAH or systemic sclerosis.
Zdravljenje z zdravilom STAYVEER mora uvesti in nadzirati zdravnik z izkušnjami v zdravljenju
> 3 and ≤ 5 × ULN The result should be confirmed by a second liver test; if confirmed, a decision should be made on an individual basis to continue STAYVEER, possibly at a reduced dose, or to stop STAYVEER administration (see section 4.2).
se za vsakega posameznega bolnika odločite, ali boste z zdravljenjem z zdravilom STAYVEER nadaljevali, morebiti znižali odmerek ali dajanje zdravila STAYVEER prekinili (glejte poglavje 4.2).
• Pregnancy (see sections 4.4 and 4.6)
• sočasna uporaba ciklosporina A (glejte poglavje 4.5) • nosečnost (glejte poglavji 4.4 in 4.6)
Jul ______
Jan ______ Maj ______ Sep _____ Feb ______ Jun ______ Okt _____ Mar ______ Jul ______ Nov _____ Apr ______ Avg ______ Dec _____
However, long-term vital status was recorded for all 235 patients who were treated with bosentan in the two pivotal placebo-controlled studies (AC-052-351 and AC-052-352) and/or their two uncontrolled, open-label extensions.
Vendar so v dveh ključnih s placebom nadzorovanih študijah (AC-052-351 in AC-052
STAYVEER 62.5 mg film-coated tablets bosentan
STAYVEER 62,5 mg filmsko obložene tablete bosentan
Treatment with bosentan was associated with a reduction in the rate of clinical worsening, defined as a composite of symptomatic progression, hospitalisation for PAH and death, compared with placebo (proportional risk reduction 77%, 95% confidence interval [CI] 20-94%, p = 0.0114).
Zdravljenje z bosentanom so povezali z zmanjšanjem stopnje kliničnega poslabšanja, opredeljeno kot sklop simptomatičnega napredovanja, hospitalizacije zaradi PAH in smrti v primerjavi s placebom
You need to use a barrier form of birth control - like a condom, diaphragm or vaginal sponge - in addition to any of these kinds of hormonal birth control.
Poleg katerekoli oblike hormonske kontracepcije morate uporabiti pregradno metodo, kot so kondom, diafragma ali kontracepcijska spužva.
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 • Moderate to severe hepatic impairment, i.e., Child-Pugh class B or C (see section 5.2)
• srednje do hudo okvarjeno delovanje jeter, tj. razred B ali C po Child-Pughu (glejte poglavje
• facilitate patients' awareness of the need for regular blood tests for liver function.
Namen opozorilne kartice za bolnika, ki je sestavni del pakiranja zdravila, je: • olajšati ozaveščanje bolnika o potrebi rednih krvnih preiskav zaradi preverjanja delovanja jeter.
Some improvements have also been shown in patients with pulmonary arterial hypertension WHO functional class II (see section 5.1).
Določena izboljšanja so se pokazala tudi pri bolnikih s pljučno arterijsko hipertenzijo II.
Pregelatinised starch Sodium starch glycolate (Type A) Povidone
Jedro tablete: koruzni škrob predgeliran škrob natrijev karboksimetilškrob (vrsta A) povidon glicerildibehenat magnezijev stearat
Please see also section 3.
(glejte tudi poglavje 4.4).
For the same reason, concomitant administration of both a potent CYP3A4 inhibitor (such as ketoconazole, itraconazole or ritonavir) and a CYP2C9 inhibitor (such as voriconazole) with STAYVEER is not recommended.
itrakonazolom ali ritonavirjem) in tudi zaviralcem CYP2C9 (denimo, vorikonazolom).
STATEMENT OF ACTIVE SUBSTANCE(S)
Izhodiščna vrednost (IV);
Cartons contain 56 film-coated tablets (STAYVEER 62.5 mg film-coated tablets).
Škatle vsebujejo 56 filmsko obloženih tablet (zdravilo STAYVEER 62,5 mg filmsko obložene tablete).
Patients had primary pulmonary hypertension (10 patients) or PAH related to congenital heart diseases (9 patients) and were in WHO functional class II (n = 15, 79%) or class III (n = 4, 21%) at baseline.
(10 bolnikov) ali PAH, povezano s prirojenimi boleznimi srca (9 bolnikov) in so bili po klasifikaciji
Cardiac disorders
Chronic Heart Failure).
Efficacy in adult patients with pulmonary arterial hypertension Two randomised, double-blind, multi-centre, placebo-controlled studies have been conducted in 32 (study AC-052-351) and 213 (study AC-052-352 [BREATHE-1]) adult patients with WHO functional class III-IV PAH (primary pulmonary hypertension or pulmonary hypertension secondary mainly to scleroderma).
32 (študija AC-052-351) in 213 (študija AC-052-352 [BREATHE-1]) odraslih bolnikih s PAH III. do
Each film-coated tablet contains 62.5 mg bosentan (as monohydrate)
Ena filmsko obložena tableta vsebuje 62,5 mg bosentana v obliki bosentana monohidrata