FrancophonIA/ELRC3.0 huggingface dataset:
English: If it is possible that you could become pregnant, use a reliable form of birth control (contraception) while you are taking STAYVEER.
Slovak: Pokiaľ počas liečby STAYVEERom môžete otehotnieť, používajte spoľahlivé metódy kontroly počatia (antikoncepciu).
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).
Slovak: V 28. týždni bola liečba bosentanom spojená so signifikantným znížením podielu klinického zhoršenia v porovnaní s placebom (10,7
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.
Slovak: U dospelých pacientov sa má liečba STAYVEERom začať dávkou 62,5 mg dvakrát denne počas štyroch týždňov a potom zvýšiť na udržiavaciu dávku 125 mg dvakrát denne.
English: • The median time to complete weaning from mechanical ventilation was 10.8 days (95% CLs 3.21, 12.21 days) on bosentan and 8.6 days (95% CLs 3.71, 9.66 days) on placebo (p = 0.24).
Slovak: • medián času do úplného vysadenia mechanickej ventilácie bol 10,8 dňa (95 % CLs 3,21; 12,21
English: At baseline in FUTURE 1, 9 patients were taking epoprostenol.
Slovak: užívalo 9 pacientov epoprostenol.
English: STAYVEER 62.5 mg film-coated tablets Each film-coated tablet contains 62.5 mg bosentan (as monohydrate).
Slovak: STAYVEER 62,5 mg filmom obalené tablety Každá filmom obalená tableta obsahuje 62,5 mg bosentanu (vo forme monohydrátu).
English: 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).
Slovak: Uskutočnili sa dve randomizované, dvojito zaslepené, multicentrické, placebom kontrolované štúdie s 32 (štúdia AC-052-351) a 213 (štúdia AC-052-352 [BREATHE-1]) dospelými pacientmi s PAH
English: Treatment should only be initiated and monitored by a physician experienced in the treatment of systemic sclerosis.
Slovak: Systémová skleróza s pokračujúcou vredovou chorobou prstov Liečbu má začať a monitorovať iba lekár so skúsenosťami s liečbou systémovej sklerózy.
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.
Slovak: Boli pozorované zvýšenie minútovej ventilácie a pokles saturácie kyslíkom.
English: • a blood test to check your liver function
Slovak: • krvný test na stanovenie funkcie pečene
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.
Slovak: Súbežné podávanie bosentanu 125 mg dvakrát denne a lopinaviru + ritonaviru 400 + 100 mg dvakrát denne počas 9,5 dňa zdravým dobrovoľníkom viedlo k zvýšeniu plazmatickej hladiny bosentanu, ktorá bola 48násobne vyššia ako pri podaní samotného bosentanu.
English: Pulmonary arterial hypertension
Slovak: pľúcna (arteriálna) hypertenzia (20
English: Recommended dose Adult
Slovak: Odporúčaná dávka
English: • One patient in the bosentan group had treatment failure (need for ECMO as per protocol definition), which was declared based on increasing Oxygenation Index values within 8 h after the first study drug dose.
Slovak: podľa definície podľa protokolu), ktoré sa prejavilo na základe zvyšujúcich sa hodnôt oxygenačného indexu v priebehu 8 hodín po prvej dávke hodnoteného liečiva.
English: STAYVEER”
Slovak: STAYVEERom
English: Cartons contain 56 film-coated tablets.
Slovak: Balenia obsahujúce 56 filmom obalených tabliet.
English: Liver test abnormalities
Slovak: Abnormality pečeňových testov
English: STAYVEER 62.5 mg film-coated tablets STAYVEER 125 mg film-coated tablets
Slovak: STAYVEER 62,5 mg filmom obalené tablety STAYVEER 125 mg filmom obalené tablety
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).
Slovak: 1,17; 6,95) pri bosentane a 2,9 dňa (95 % CLs 1,26; 4,23) pri placebe (p =
English: 40.6% (26/64) remained on bosentan monotherapy during the 24 weeks of study treatment without experiencing PAH worsening.
Slovak: % [29/64]) nekombinovaným s ďalšími liekmi proti PAH. 40,6 % (26/64) ostalo počas 24 týždňov hodnotenej liečby na monoterapii bosentanom.
English: Based on these findings and preclinical data, it cannot be excluded that bosentan may have a detrimental effect on spermatogenesis in men.
Slovak: že bosentan môže mať u mužov škodlivý účinok na spermatogenézu.
English: Elevations to ≥ 8 × ULN were seen in 3.6% of the bosentan-treated patients and 0.4% of the placebo-treated patients.
Slovak: HHN bolo zaznamenané u 3,6 % bosentanom liečených pacientov a 0,4
English: Patients could receive additional PAH treatment as required in the open-label extension.
Slovak: Počas predĺženia otvorenej štúdie pacienti s PAH mohli užívať doplnkovú liečbu.
English: Development of testicular tubular atrophy and impaired fertility has been linked with chronic administration of endothelin receptor antagonists in rodents.
Slovak: S chronickým podávaním antagonistov endotelínového receptora hlodavcom sa spája rozvoj testikulárnej tubulárnej atrofie a zhoršenie fertility.
English: - STAYVEER 125 mg film-coated tablets: The active substance is bosentan as monohydrate.
Slovak: - STAYVEER 125 mg filmom obalené tablety: liečivo je bosentan vo forme monohydrátu.
English: No specific study has been performed in patients with pulmonary hypertension and concomitant left ventricular dysfunction.
Slovak: U pacientov s pľúcnou artériovou hypertenziou a súčasnou dysfunkciou ľavej komory nebola uskutočnená žiadna špeciálna štúdia.
English: Of the 7 patients who deteriorated at week 8, 3 improved at week 12/16 and 4 deteriorated compared with baseline.
Slovak: 8. týždeň, sa u 3 v týždňoch 12/16 výkon zlepšil a u 4 nastalo zhoršenie v porovnaní so vstupným meraním.
English: Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH.
Slovak: Pľúcna artériová hypertenzia Liečbu má začať a monitorovať iba lekár so skúsenosťami s liečbou PAH.
English: Treatment must be stopped and re-introduction of STAYVEER is not to be considered.
Slovak: svalov, horúčka), musí byť liečba ukončená a opätovné nasadenie STAYVEERu nie je možné.
English: The median exposure to study treatment was 4.5 (range: 0.5-10.0) days in the bosentan group and 4.0 (range: 2.5-6.5) days in the placebo group.
Slovak: Medián expozície hodnotenej liečbe bol 4,5 (rozpätie 0,5 až 10,0) dňa v skupine liečených bosentanom
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.
Slovak: Súbežné podávanie s flukonazolom, ktorý inhibuje najmä CYP2C9 a do určitej miery aj CYP3A4, môže viesť k výraznému zvýšeniu plazmatických hladín bosentanu, a preto sa táto kombinácia neodporúča.
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.
Slovak: Súbežné podávanie bosentanu 125 mg dvakrát denne počas 7 dní s rifampicínom, potentným induktorom CYP2C9 a CYP3A4, 9 zdravým osobám znížilo plazmatické hladiny bosentanu o 58 %, pričom tento pokles dosahoval u jednotlivcov až 90 %. Ako výsledok možno preto pri súbežnom podávaní bosentanu s rifampicínom očakávať významné zníženie účinku bosentanu.
English: Aminotransferase elevations associated with hepatitis (including possible exacerbation of underlying hepatitis) and/or jaundice1 (see section 4.4)
Slovak: Zvýšenie hladiny aminotransferáz spojené s hepatitídou (vrátane možného zhoršenia skrytej hepatitídy)
English: MARKETING AUTHORISATION NUMBER(S)
Slovak: Hladina štatistickej významnosti - p
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.
Slovak: 7), čo sa podobá expozícii pozorovanej u dospelých pacientov s PAH liečených 125 mg dvakrát denne, pričom sa berie do úvahy distribučný pomer krv/plazma 0,6.
English: 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.
Slovak: EARLY]) dostávalo 185 pacientov s PAH funkčnej triedy II podľa WHO (s priemernou vzdialenosťou v 6-minútovom teste chôdze 435 metrov) najskôr 62,5 mg bosentanu dvakrát denne počas 4 týždňov a následne počas 6 mesiacov buď 125 mg bosentanu dvakrát denne (n =
English: Dec _____
Slovak: Nie ______
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.
Slovak: Preto je nutné zvážiť prítomnosť súčasnej venookluzívnej choroby, ak sa pri podávaní STAYVEERu pacientom s PAH objavia príznaky pľúcneho edému.
English: Bosentan is eliminated by biliary excretion following metabolism in the liver by the cytochrome P450 isoenzymes, CYP2C9 and CYP3A4.
Slovak: Bosentan je eliminovaný žlčou po metabolizácii v pečeni izoenzýmami CYP2C9 a CYP3A4
English: Treatment with diuretics should be considered in patients with evidence of fluid retention before the start of treatment with STAYVEER.
Slovak: U pacientov so známkami retencie tekutín pred začiatkom liečby STAYVEERom je potrebné zvážiť liečbu diuretikami.
English: Nasal congestion1
Slovak: Upchatý nos1
English: In the patients above 2 years (n = 22) the daily exposure was 8,820 ng·h/mL; AUCτ was 4,410 ng·h/mL (CV: 58%).
Slovak: 22) bola denná expozícia 8820 ng·h/ml; AUCτ bola 4410 ng·h/ml (CV: 58 %).
English: STAYVEER 125 mg film-coated tablets are orange-white, oval film-coated tablets with “125” on one side.
Slovak: STAYVEER 125 mg, filmom obalené tablety sú oranžovobiele, oválne, filmom obalené tablety s vystupujúcim popisom “125” na jednej strane.
English: Liver cirrhosis, liver failure1
Slovak: Cirhóza pečene, zlyhanie pečene1
English: - STAYVEER 62.5 mg film-coated tablets: The active substance is bosentan as monohydrate.
Slovak: - STAYVEER 62,5 mg filmom obalené tablety: liečivo je bosentan vo forme monohydrátu.
English: Yes
Slovak: ALEBO
English: Eisenmenger's physiology
Slovak: Eisenmengorovho syndrómu (13
English: STAYVEER 62.5 mg film-coated tablets are orange-white, round film-coated tablets with “62,5” on one side.
Slovak: STAYVEER 62,5 mg, filmom obalené tablety sú oranžovobiele, okrúhle, filmom obalené tablety s vystupujúcim popisom “62,5” na jednej strane.
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.
Slovak: Digoxín: Súbežné podávanie bosentanu 500 mg dvakrát denne počas 7 dní s digoxínom znížilo AUC
English: 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.
Slovak: súvisiacu s kongenitálnym ochorením srdca (9 pacientov) a na začiatku sledovania boli v II. (n =
English: In BREATHE-3, the most frequent adverse reactions were flushing (21%), headache, and abnormal liver function test (each 16%).
Slovak: V štúdii BREATHE-3 boli najčastejšími nežiaducimi reakciami sčervenanie (21
English: Cartons contain 56 film-coated tablets (STAYVEER 125 mg film-coated tablets).
Slovak: Škatuľka obsahuje 56 filmom obalených tabliet (STAYVEER 125 mg filmom obalené tablety).
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.
Slovak: 8) podávaným nazogastrickou sondou ako prídavná liečba k iNO do kompletného vysadenia iNO alebo do zlyhania liečby (definovaného ako potreba extrakorporálnej membránovej oxygenácie [ECMO] alebo nasadenia alternatívneho pľúcneho vazodilatátora) počas maximálne 14 dní.
English: These will be done every month for the duration of treatment with STAYVEER.
Slovak: Krvné testy pečeňových funkcií Tieto testy sa robia každý mesiac počas celej liečby STAYVEERom.
English: STAYVEER 125 mg film-coated tablets bosentan
Slovak: STAYVEER 125 mg filmom obalené tablety bosentan
English: Each tablet contains 62.5 mg of bosentan (as monohydrate).
Slovak: Každá tableta obsahuje 62,5 mg bosentanu (vo forme monohydrátu).
English: However, no effects on general development, growth, sensory, cognitive function and reproductive performance were detected at 7 (males) and 19 (females) times the human therapeutic exposure at Day 21 post partum.
Slovak: 21 dní po vrhu neboli po 7-násobku (samci) a 19-násobku (samice) ľudskej terapeutickej expozície zistené žiadne účinky na celkový vývoj, rast a kognitívne funkcie, reprodukčné schopnosti.
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.
Slovak: Warfarín: Súbežné podávanie bosentanu 500 mg dvakrát denne počas 6 dní znížilo plazmatické hladiny S-warfarínu (substrát CYP2C9) o 29 % a R-warfarínu (substrát CYP3A4) o 38 %. Počas klinických štúdií u pacientov s PAH, ktorým boli súbežne podávané bosentan a warfarín, neboli pozorované žiadne klinicky relevantné zmeny INR (International Normalized Ratio) ani dávky warfarínu (porovnanie vstupných hodnôt s hodnotami na konci klinických štúdií).
English: Cartons contain 56 film-coated tablets (STAYVEER 62.5 mg film-coated tablets).
Slovak: Škatuľka obsahuje 56 filmom obalených tabliet (STAYVEER 62,5 mg filmom obalené tablety).
English: 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).
Slovak: (95 % CI) aktívneho metabolitu Ro 48-5033 bola 106 (58,4-192) ng⋅h/ml, t.j. 12,4krát vyššia ako u pacientov s normálnou funkciou pečene (bosentan: priemerná AUC
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.
Slovak: 3), používajúcej dispergovateľné tablety, bola expozícia bosentanu u pacientov liečených dávkou 2 mg/kg dvakrát denne porovnateľná s expozíciou v štúdii FUTURE
English: STAYVEER 62.5 mg film-coated tablets bosentan
Slovak: STAYVEER 62,5 mg filmom obalené tablety bosentan
English: Each tablet contains 125 mg of bosentan (as monohydrate).
Slovak: Každá tableta obsahuje 125 mg bosentanu (vo forme monohydrátu).
English: In patients between 3 months and 1 year (n = 2) AUCτ was 5,914 ng·h/mL (CV: 85%), and in patients between 1 and 2 years (n = 7) AUCτ was 3,507 ng·h/mL (CV: 70%).
Slovak: 2) bola AUCτ 5914 ng·h/ml (CV: 85 %) a u pacientov vo veku medzi 1 rokom a 2 rokmi (n =
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).
Slovak: týždňov dvojito zaslepenej liečby boli zhodné údaje pre nové vredy na prstoch 1,9, resp. 2,7 (p =
English: • Pulmonary arterial hypertension associated with congenital systemic-to-pulmonary shunts and
Slovak: • pľúcnej artériovej hypertenzii spojenej s vrodeným ľavo-pravým skratom a Eisenmengerovým syndrómom
English: • Hypersensitivity reactions (including skin inflammation, itching and rash)
Slovak: • sčervenanie alebo sčervenanie kože • precitlivenosť (zahŕňajúca zápal na koži, svrbenie, červený výsev na koži)
English: Each film-coated tablet contains 62.5 mg bosentan (as monohydrate)
Slovak: Každá filmom obalená tableta obsahuje 62,5 mg bosentanu (vo forme monohydrátu).
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.
Slovak: Táto interakcia je spôsobená pravdepodobne inhibíciou vychytávania bosentanu do hepatocytov, ktoré je sprostredkované transportným proteínom a inhibíciou CYP3A4 ritonavirom a redukciou klírens bosentanu.
English: Consequently, plasma concentrations of substances metabolised by these isoenzymes will be decreased when STAYVEER is co-administered.
Slovak: V prípade súbežného podávania STAYVEERu sa plazmatické hladiny liečiv metabolizovaných týmito izoenzýmami znížia.
English: • nausea (urge to vomit)
Slovak: • nevoľnosť (pocit na vracanie)
English: Each film-coated tablet contains 125 mg bosentan (as monohydrate)
Slovak: Každá filmom obalená tableta obsahuje 125 mg bosentanu (vo forme monohydrátu).
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.
Slovak: 19, 29 %), v II. triede (n =
English: 3 Headache was reported in 11.5% of patients on bosentan and 9.8% of patients on placebo.
Slovak: % pacientov liečených bosentanom a 9,8
English: STAYVEER 125 mg film-coated tablets Orange-white, oval, biconvex, film-coated tablets, embossed with “125” on one side.
Slovak: Oranžovobiele, oválne, bikonvexné, filmom obalené tablety s vystupujúcim popisom “125” na jednej strane.
English: Pregelatinised starch Sodium starch glycolate (Type A) Povidone
Slovak: Povidón Glyceroldibehenát
English: Kaplan-Meier estimates of survival were 90% and 85% at 3 and 4 years after the start of treatment, respectively.
Slovak: V treťom roku prežilo 90 % a v štvrtom roku 85 % pacientov podľa Kaplan Majerovej krivky mortality.
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.
Slovak: FUTURE 3/predĺženie bol u 10,0 % pacientov hlásený pokles hladiny hemoglobínu zo začiatočnej hodnoty na hodnotu menej ako 10 g/dl.
English: No effect of bosentan on time to healing of digital ulcers was observed in either study.
Slovak: Ani v jednej z obidvoch štúdií sa nepozoroval žiadny účinok bosentanu na rýchlosť vyhojenia vredov na prstoch.
English: • dark-coloured urine
Slovak: • tmavo zafarbený moč
English: Cartons contain 56 or 112 film coated tablets (STAYVEER 62.5 mg film-coated tablets).
Slovak: alebo 112 filmom obalených tabliet (STAYVEER 62,5 mg filmom obalené tablety).
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.
Slovak: 2 mg/kg dvakrát denne; dĺžka liečby 12 týždňov) bol podobný s bezpečnostným profilom pozorovaným v pivotných štúdiách u dospelých pacientov s PAH.
English: Uncommon (may affect up to one in 100 people):
Slovak: Menej časté (môžu postihovať menej ako 1 zo 100 osôb):
English: Common (may affect up to one in 10 people):
Slovak: Časté (môžu postihovať menej ako 1 z 10 osôb):
English: Sildenafil: Co-administration of bosentan 125 mg twice daily (steady state) with sildenafil 80 mg three times a day (at steady state) concomitantly administered during 6 days in healthy volunteers resulted in a 63% decrease in the sildenafil AUC and a 50% increase in the bosentan AUC.
Slovak: 80 mg trikrát denne (rovnovážny stav) počas šiestich dní u zdravých dobrovoľníkov viedlo k 63%
English: The majority of patients were diagnosed as primary pulmonary hypertension (72%) and were in WHO functional class III (84%).
Slovak: Väčšina z nich mala diagnostikovanú primárnu pľúcnu hypertenziu (72
English: In study AC-052-365 (FUTURE 1), dispersible tablets were administered in 36 PAH children aged from 2 to 11 years.
Slovak: 1) boli podávané dispergovateľné tablety u 36 detí s PAH vo veku 211 rokov.
English: STAYVEER 62.5 mg film-coated tablets Orange-white, round, biconvex, film-coated tablets, embossed with “62,5” on one side.
Slovak: Oranžovobiele, okrúhle, bikonvexné, filmom obalené tablety s vystupujúcim popisom “62,5” na jednej strane.
English: Bosentan is an inducer of the cytochrome P450 (CYP) isoenzymes CYP2C9 and CYP3A4.
Slovak: P 450 (CYP) izoenzýmov CYP2C9 a CYP3A4.
English: Ask your pharmacist how to throw away any medicines you no longer use.
Slovak: Nepoužitý liek vráťte do lekárne.
English: • caused by congenital (inborn) heart defects with shunts (abnormal passageways) causing abnormal flow of blood through the heart and lungs.
Slovak: ktorá spôsobuje vysoký krvný tlak v cievach (pľúcnych tepnách), ktoré transportujú krv zo srdca do pľúc.
English: Cartons contain 56 or 112 film coated tablets (STAYVEER 125 mg film-coated tablets).
Slovak: alebo 112 filmom obalených tabliet (STAYVEER 125 mg filmom obalené tablety).
English: How to take STAYVEER
Slovak: Neužívajte STAYVEER
English: STAYVEER with food and drink
Slovak: STAYVEER a jedlo a nápoje
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.
Slovak: 052-405 [BREATHE-5]) dostávali pacienti s PAH III. triedy podľa funkčnej klasifikácie WHO a
English: STAYVEER is contraindicated in patients with moderate to severe hepatic impairment, i.e., Child-Pugh class B or C (see section 4.3).
Slovak: STAYVEER je kontraindikovaný u pacientov s miernou a závažnou poruchou funkcie pečene t. j.
English: The placebo-corrected increases in walk distance compared with baseline were 76 metres (p = 0.02; t-test) and 44 metres (p = 0.0002; Mann-Whitney U test) at the primary endpoint of each study, respectively.
Slovak: Placebom korigované predĺženie vzdialenosti chôdze oproti vstupným hodnotám v zmysle primárneho kritéria hodnotenia každej štúdie bolo 76 metrov (p =
English: Flushing
Slovak: Hypromelóza
English: Gastrooesophageal reflux disease Diarrhoea
Slovak: Refluxná choroba pažeráka,
English: After 16 weeks, the mean oxygen saturation was increased in the bosentan group by 1.0% (95% CI -0.7%-2.8%) as compared to the placebo group (n = 17), showing that bosentan did not worsen hypoxaemia.
Slovak: Po 16 týždňoch sa priemerná saturácia kyslíkom u skupiny liečenej bosentanom zvýšila o 1,0
English: 164 ng·h/mL, n = 11).
Slovak: 31) alebo 4 mg/kg dvakrát denne (n =
English: Less than 3% of an administered oral dose is recovered in urine.
Slovak: cytochrómu P450. Menej než 3 % perorálne aplikovanej dávky sa nachádzajú v moči.
English: • Concomitant use of cyclosporine A (see section 4.5)
Slovak: A (pozri časť 4.5)
English: Appropriate precautions must be taken for women of childbearing potential (see sections 4.3, 4.4 and 4.6).
Slovak: A je kontraindikované (pozri časti 4.3 a 4.5).