natgillin/translations-raw huggingface dataset:
Bosentan film-coated tablets were evaluated in an open-label uncontrolled study in 19 paediatric patients with PAH aged 3 to 15 years.
Bosentan u obliku filmom obloženih tableta procijenjen je u otvorenoj nekontroliranoj studiji na 19 pedijatrijskih bolesnika s PAH-om u dobi od 3 do 15 godina.
This combination should not be used.
Stoga se ta kombinacija lijekova ne smije uzimati.
Elevations in aminotransferases were associated with elevated bilirubin (≥ 2 × ULN) without evidence of biliary obstruction in 0.2% (5 patients) on bosentan and 0.3% (6 patients) on placebo.
Povećanje aminotransferaza bilo je povezano s povećanjem bilirubina (≥ 2 × GGN) bez dokaza opstrukcije žuči u 0,2% (5 bolesnika) koji su dobivali bosentan i 0,3% (6 bolesnika) koji su dobivali placebo.
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.
Uočena je lagano povećana incidencija tubularne atrofije testisa u štakora koji su primali bosentan peroralno u niskim dozama od 125 mg/kg/dan (otprilike 4 puta više od maksimalne preporučene doze za ljude [MRHD, engl. maximum recommended human dose] i najniža ispitivana doza) tijekom dvije godine, ali ne i pri visokim dozama od 1500 mg/kg/dan (otprilike 50 puta više od MRHD)
Appropriate precautions must be taken for women of childbearing potential (see sections 4.3, 4.4 and 4.6).
U žena reproduktivne dobi treba poduzeti odgovarajuće mjere opreza (vidjeti dijelove 4.3, 4.4 i 4.6).
STAYVEER is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease (see section 5.1).
STAYVEER je također indiciran za smanjenje broja novih ulceracija na prstima kod bolesnika sa sistemskom sklerozom i aktivnom bolešću ulceracija prstiju (vidjeti dio 5.1).
Enrolled patients were PAH-treatment-naïve (n = 156) or on a stable dose of sildenafil (n = 29).
Uključeni bolesnici do tada nisu dobivali terapiju za PAH (n = 156) ili su dobivali stalnu dozu sildenafila (n = 29).
The treatment in adults is usually started for the first 4 weeks with 62.5 mg twice daily (morning and evening), from then your doctor will usually advise you to take a 125 mg tablet twice daily, depending on how you react to STAYVEER.
Liječenje odraslih bolesnika obično započinje tijekom prva 4 tjedna dozom od 62,5 mg dva puta dnevno (ujutro i navečer), a potom će Vam liječnik vjerojatno savjetovati da uzimate 125 mg dva puta dnevno, ovisno o Vašoj reakciji na STAYVEER.
Therefore, if you use hormonal contraceptives you must also use a barrier method (e.g., female condom, diaphragm, contraceptive sponge, or your partner must also use a condom).
Stoga, ako koristite hormonsku kontracepciju, ujedno morate koristiti i metodu barijere (npr. ženski kondom, dijafragmu, kontracepcijsku spužvu ili
At baseline in FUTURE 1, 9 patients were taking epoprostenol.
Na početku FUTURE 1 studije, 9 bolesnika je uzimalo epoprostenol.
In the post-marketing period rare cases of unexplained hepatic cirrhosis were reported after prolonged therapy with STAYVEER in patients with multiple co-morbidities and therapies with medicinal products.
U postmarketinškom razdoblju prijavljeni su rijetki slučajevi neobjašnjive ciroze jetre nakon produljene terapije STAYVEEROM u bolesnika s višestrukim istodobnim pobolijevanjima i terapijama lijekovima.
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.
Sigurnosni profil u prvoj nekontroliranoj pedijatrijskoj studiji provedenoj s filmom obloženom tabletom (BREATHE-3: n = 19, medijan dobi 10 godina [raspon 3-15 godina], otvoreno davanje bosentana 2 mg/kg dvaput dnevno; trajanje liječenja 12 tjedana) bio je sličan kao kod pivotalnih studija odraslih bolesnika s PAH-om.
The mean pulmonary vascular resistance was significantly reduced in the bosentan group (with a predominant effect observed in the subgroup of patients with bidirectional intracardiac shunt).
Srednji plućni krvožilni otpor bio je značajno manji u skupini koja je dobivala bosentan (najveći učinak primijećen je u podskupini bolesnika koji su imali dvosmjerni unutarsrčani šant).
At baseline, patients had idiopathic (31 patients [86%]) or familial (5 patients [14%]) PAH, and were in WHO functional class II (n = 23, 64%) or class III (n = 13, 36%).
Na početku studije, bolesnici su imali idiopatski (31 bolesnik [86%]) ili obiteljski (5 bolesnika [14%]) PAH i bili su funkcionalnog stupnja II (n = 23, 64%) ili III (n = 13, 36%) prema WHO.
He had symptoms of nausea, vomiting, hypotension, dizziness, sweating and blurred vision.
Imao je simptome mučnine, povraćanja, hipotenzije, vrtoglavice,
• Pulmonary arterial hypertension associated with congenital systemic-to-pulmonary shunts and
• Plućne arterijske hipertenzije povezane s kongenitalnim sistemsko-plućnim šantom i
STAYVEER 62.5 mg film-coated tablets EU/1/13/832/001
STAYVEER 62,5 mg filmom obložene tablete EU/1/13/832/001
It is important that you have these tests as ordered by your doctor.
Važno je da provodite sve pretrage prema uputama liječnika.
Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172) Ethylcellulose
Film ovojnica: hipromeloza gliceroltriacetat talk titanijev dioksid (E171) željezov oksid žuti (E172) željezov oksid crveni (E172) etilceluloza
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 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
If you forget to take STAYVEER
Ako ste zaboravili uzeti STAYVEER
When treatment with STAYVEER is initiated in patients who require ritonavir-boosted protease inhibitors, the patient's tolerability of STAYVEER should be closely monitored with special attention, at the beginning of the initiation phase, to the risk of hypotension and to liver function tests.
Kada je terapija STAYVEEROM započeta kod bolesnika koji zahtijevaju liječenje ritonavirom - inhibitorom proteaze, bolesnikovu podnošljivost STAYVEERA treba pomno pratiti s posebnom pažnjom na početku faze uvođenja, s obzirom na rizik od hipotenzije i nalaze funkcije jetre.
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.
43 (67,2%) ih je bilo ≥ 2 do 11 godina starosti, 15 (23,4%) ih je bilo između 1 i 2 godine starosti te njih 6 (9,4%) bilo je staro između 3 mjeseca i 1 godine.
In this study, fluid retention was manifested by early weight gain, decreased haemoglobin concentration and increased incidence of leg oedema.
U toj studiji zadržavanje tekućine odrazilo se putem ranog povećanja tjelesne težine, smanjenja koncentracije hemoglobina i povećane učestalosti edema nogu.
Bosentan decreases both pulmonary and systemic vascular resistance resulting in increased cardiac output without increasing heart rate.
Bosentan smanjuje plućni i sistemski krvožilni otpor te tako povećava minutni volumen srca bez povećanja srčane frekvencije.
Blood tests for anaemia
Krvne pretrage za anemiju
Pulmonary hypertension secondary to chronic obstructive pulmonary disease (COPD)
Plućna hipertenzija kao posljedica kronične opstruktivne plućne bolesti (KOPB)
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).
Najčešći štetni događaji u bolesnika koji su primali bosentan i placebo bili su: anemija ili smanjenje razine hemoglobina (u 7 odnosno 2 bolesnika), generalizirani edem (u 3 odnosno 0 bolesnika) i povraćanje (u 2 odnosno 0 bolesnika).
STAYVEER may harm the development of the foetus.
Lijek STAYVEER može naškoditi razvoju fetusa.
The mechanism of this interaction is most likely inhibition of transport protein-mediated uptake of bosentan into hepatocytes by cyclosporine.
Najvjerojatnije je mehanizam te interakcije inhibicija ciklosporinom transportnog proteina kojim se bosentan unosi u hepatocite.
Gastrooesophageal reflux disease Diarrhoea
Gastroezofagealna refluksna bolest
Paediatric pharmacokinetic data have shown that bosentan plasma concentrations in children with PAH aged from 1 year to 15 years were on average lower than in adult patients and were not increased by increasing the dose of STAYVEER above 2 mg/kg body weight or by increasing the dosing frequency from twice daily to three times daily (see section 5.2).
Pedijatrijski farmakokinetički podaci pokazali su da su koncentracije bosentana u plazmi kod djece s PAH-om u dobi od 1 do 15 godina u prosjeku bile niže nego kod odraslih bolesnika i nisu se povećale povećanjem doze STAYVEERA iznad 2 mg/kg tjelesne težine ili povećanjem učestalosti doziranja s dvaput dnevno na triput dnevno (vidjeti dio 5.2).
Before the initiation of STAYVEER treatment in women of childbearing potential, the absence of pregnancy should be checked, appropriate advice on reliable methods of contraception provided, and reliable contraception initiated.
Prije početka liječenja STAYVEEROM žena reproduktivne dobi treba provjeriti da nisu trudne, dati im odgovarajuće savjete o pouzdanim metodama kontracepcije i inicirati pouzdanu kontracepciju.
Adverse reactions were defined as events occurring in at least 1% of patients on bosentan and at a frequency at least 0.5% more than on placebo.
Nuspojave su definirane kao reakcije koje su se pojavile kod najmanje 1% bolesnika koji su dobivali bosentan i s učestalošću od najmanje 0,5% više nego kod onih koji su dobivali placebo.
• Pulmonary arterial hypertension secondary to scleroderma without significant interstitial pulmonary disease
• Plućne arterijske hipertenzije koja se javlja kao posljedica sklerodermije bez značajne intersticijske plućne bolesti
STAYVEER contains sodium
STAYVEER sadrži natrij
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.
Studija AC-052-356 (BREATHE-3) procijenila je farmakokinetiku pojedinačnih i višekratnih oralnih doza bosentana u obliku filmom obloženih tableta u 19 djece u dobi od 3 do 15 godina s PAH-om koji su dobivali dozu na temelju njihove tjelesne težine od 2 mg/kg dvaput dnevno.
Blurred vision1
Zamagljen vid1
Survival estimates were lower in the subgroup of patients with PAH secondary to systemic sclerosis.
Procjena preživljenja bila je niža u podskupini bolesnika koji su imali PAH usporedno sa sistemskom sklerozom.
There was one hospitalisation related to PAH worsening in the bosentan group and three hospitalisations in the placebo group.
U skupini koja je dobivala bosentan došlo je do jedne hospitalizacije zbog pogoršanja PAH-a te do tri hospitalizacije u skupini koja je dobivala placebo.
• cyclosporine A (a medicine used after transplants and to treat psoriasis), which must not be used together with STAYVEER.
• ciklosporin A (lijek koji se uzima nakon transplantacije i za liječenje psorijaze) koji se ne smije koristiti zajedno sa STAYVEEROM
The treatment effect was driven by improvement in the component symptomatic progression.
Učinkovitost liječenja zasnivala se ponajviše na smanjenju napredovanja simptoma.
• 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).
• Medijan vremena do potpunog odvikavanja od iNO bio je 3,7 dana (95% granice sigurnosti [CL] 1,17; 6,95) uz bosentan i 2,9 dana (95% CL 1,26; 4,23) uz placebo (p = 0,34).
The pharmacokinetics of bosentan have not been studied in patients with Child-Pugh class C hepatic impairment.
Farmakokinetika bosentana nije ispitivana u bolesnika sa smanjenjem jetrene funkcije Child-Pugh stadij C.
The number of new digital ulcers from baseline to study endpoint was a primary endpoint in both studies.
Broj novih ulceracija prstiju na kraju liječenja u odnosu na početak liječenja bio je primarna mjera ishoda za obje studije.
Clinical experience with concomitant administration of bosentan with warfarin in patients with PAH did not result in clinically relevant changes in International Normalized Ratio (INR) or warfarin dose (baseline versus end of the clinical studies).
Tijekom kliničkih studija istodobne primjene bosentana i varfarina u bolesnika s PAH-om nije došlo do klinički značajnih promjena internacionalnog normaliziranog omjera (INR) ili doze varfarina (između početne i krajnje vrijednosti u kliničkim studijama).
There are no studies to demonstrate beneficial effects of STAYVEER treatment on survival.
Ne postoje studije koje bi pokazale povoljno djelovanje liječenja STAYVEEROM na preživljenje bolesnika.
STAYVEER is not recommended in paediatric patients with systemic sclerosis and ongoing digital ulcer disease.
STAYVEER se ne preporučuje pedijatrijskim bolesnicima sa sistemskom sklerozom i prisutnim ulceracijama na prstima.
Blood and lymphatic system disorders
Poremećaji krvi i limfnog sustava Često
Therefore, you must not take STAYVEER if you are pregnant and you must also not become pregnant while taking STAYVEER.
Zbog toga ne smijete uzimati STAYVEER ako ste trudni te ne smijete zatrudnjeti tijekom uzimanja STAYVEERA.
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.
Međutim, kada se kombinira sa inhibitorima CYP3A4, u bolesnika sa smanjenim djelovanjem CYP2C9 postoji rizik od većih povećanja koncentracije bosentana u plazmi, koja mogu uzrokovati štetne događaje.
• At the request of the European Medicines Agency.
Ažurirani RMP treba dostaviti: • na zahtjev Europske agencije za lijekove
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).
U placebom kontroliranim studijama na odraslima, smanjenje koncentracije hemoglobina ispod 10 g/dl od početne vrijednosti prijavljeno je kod 8,0% bolesnika koji su dobivali bosentan i 3,9% bolesnika koji su dobivali placebo (vidjeti dio 4.4).
STAYVEER has not been shown to have a beneficial effect on the healing of existing digital ulcers.
Za STAYVEER nije pokazano da je učinkovit u zacjeljivanju postojećih ulceracija prstiju.
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).
U studiji AC-052-331 tijekom 24 tjedna dvostruko slijepe terapije pojavilo se 1,9, odnosno 2,7 novih ulceracija prstiju (p = 0,0351).
Dosing bosentan 2 mg/kg three times daily did not increase exposure; daily exposure was 7,275 ng·h/mL (CV: 83%, n = 27).
Doziranje bosentana od 2 mg/kg triput dnevno nije povećalo izloženost; dnevna izloženost bila je 7275 ng•h/mL (CV: 83%, n = 27).
The overall goal of the Patient Alert Card is to educate patients on important safety information that they need to be aware of before and during treatment with STAYVEER.
Općeniti je cilj Kartice s upozorenjima za bolesnika upoznati bolesnike s važnim sigurnosnim informacijama kojih moraju biti svjesni prije i tijekom liječenja lijekom STAYVEER.
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.
funkcionalnog stupnja i dispneje, na 95 bolesnika koji su dobivali bosentan 125 mg dvaput dnevno u randomiziranoj, placebom kontroliranoj studiji, pronađeno je da je nakon 8 tjedana u 66 bolesnika stanje bilo poboljšano, u 22 stabilno, a u 7 pogoršano.
Upon multiple dosing, plasma concentrations of bosentan decrease gradually to 50-65% of those seen after single dose administration.
Nakon višestrukog doziranja, koncentracije bosentana u plazmi postupno se smanjuju do 50-65%
After an increase in dose, an additional test will be done after 2 weeks.
Nakon povećanja doze trebat će napraviti nove pretrage nakon 2 tjedna.
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).
Medijan trajanja liječenja bosentanom bio je 4,5 dana (raspon 0,5-10,0 dana), a placebom 4,0 dana (raspon 2,5-6,5 dana).
The majority of patients were diagnosed as primary pulmonary hypertension (72%) and were in WHO functional class III (84%).
Većina bolesnika imala je dijagnozu primarne plućne hipertenzije (72%) te su bili u skupini III prema WHO
• Digital ulcers: (sores on the fingers and toes) in adult patients with a condition called scleroderma.
• ulceracija na prstima (rane na prstima ruku i nogu) koje se javljaju kod odraslih oboljelih od sklerodermije.
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.
Srednje AUC (CV%) vrijednosti bosentana u pedijatrijskih bolesnika koji su dobivali 31,25, 62,5 ili 125 mg dvaput dnevno bile su 3496 (49), 5428 (79), odnosno 6124 (27) ng•h/ml te su bile niže od vrijednosti 8149 (47) ng•h/ml uočene kod odraslih bolesnika s PAH-om koji su dobivali 125 mg dvaput dnevno.
Hormonal contraceptives: Co-administration of bosentan 125 mg twice daily for 7 days with a single dose of oral contraceptive containing norethisterone 1 mg + ethinyl estradiol 35 mcg decreased the AUC of norethisterone and ethinyl estradiol by 14% and 31%, respectively.
Hormonski kontraceptivi: istodobna primjena bosentana 125 mg dvaput dnevno tijekom 7 dana s jednokratnom dozom oralnog kontraceptiva koji sadrži noretisteron 1 mg i etinilestradiol 35 μg, smanjila je AUC noretisterona i etinilestradiola za 14%, odnosno 31%.
The effect of bosentan on mitochondrial function is unknown.
Nije poznat utjecaj bosentana na funkciju mitohondrija.
Concomitant administration of both a CYP3A4 inhibitor and a CYP2C9 inhibitor with STAYVEER should be avoided (see section 4.5).
Treba izbjegavati istodobnu primjenu inhibitora CYP3A4 i CYP2C9 sa STAYVEEROM (vidjeti dio 4.5).
Should this occur, starting treatment with diuretics is recommended, or the dose of existing diuretics should be increased.
Pojave li se znakovi zadržavanja tekućine, preporučuje se započeti liječenje diureticima ili povećati dozu diuretika koje bolesnici već uzimaju.
Rare (may affect up to one in 1000 people):
Rijetke (mogu se pojaviti u do 1 na 1000 osoba):
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.
U studiji AC-052-331 bolesnici su imali barem jednu nedavnu pojavu ulceracije prstiju, a u dvije studije zajedno 85% bolesnika imalo je ulceraciju prstiju na početku.
PATIENT ALERT CARD
KARTICA S UPOZORENJIMA ZA BOLESNIKA
• sirolimus or tacrolimus, which are medicines used after transplants, as these are not recommended to be used together with STAYVEER.
• sirolimus ili takrolimus, lijekovi koji se uzimaju nakon transplantacije, budući da nije preporučljivo uzimati ih zajedno sa STAYVEEROM
In the AC-052-352 study, 92% of the 213 patients were classified at baseline as WHO functional class III and 8% as class IV.
U studiji AC-052352, 92% od 213 bolesnika imalo je prije liječenja WHO funkcionalni stupanj III, a 8% stupnaj IV.
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%).
U sveukupnoj populaciji (n = 31) primjena doze od 2 mg/kg dvaput dnevno rezultirala je dnevnom izloženošću od 8535 ng•h/mL; AUCτ je bila 4268 ng•h/mL (CV: 61%).
In the 20 integrated placebo-controlled studies, elevations in liver aminotransferases ≥ 3 ×ULN were observed in 11.2% of the bosentan-treated patients as compared to 2.4% of the placebo-treated patients.
U 20 integriranih placebom kontroliranih studija povišenje jetrenih aminotransferaza ≥ 3 × u odnosu na GGN primijećeno je u 11,2% bolesnika koji su dobivali bosentan u odnosu na 2,4% bolesnika koji su dobivali placebo.
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.
Na osnovi nalaza u studijama BREATHE-3, FUTURE 1 i FUTURE-3 pokazalo se da izloženost bosentanu doseže plato kod nižih doza u pedijatrijskih bolesnika nego u odraslih te da doze više od 2 mg/kg dvaput dnevno (4 mg/kg dvaput dnevno ili 2 mg/kg triput dnevno) neće rezultirati povećanom izloženosti bosentanu kod pedijatrijskih bolesnika.
Changes in exercise test parameters at week 12 from baseline were highly variable and none were significant.
Promjene u testu fizičkog opterećenja nakon 12 tjedana bile su jako varijabilne te nisu bile statistički značajne.
If the aminotransferase levels return to pre-treatment values reintroducing STAYVEER according to the conditions described below should be considered.
Ako se vrijednosti aminotransferaza vrate na vrijednosti prije liječenja, treba razmotriti ponovno liječenje STAYVEEROM u skladu s dolje navedenim uvjetima.
FUTURE 1 was an open-label, uncontrolled study that was conducted with the dispersible tablet formulation of bosentan administered at a maintenance dose of 4 mg/kg twice daily to 36 patients from 2 to 11 years of age.
FUTURE 1 bila je otvorena nekontrolirana studija provedena s bosentanom u obliku tablete za oralnu suspenziju primijenjenim u dozi održavanja od 4 mg/kg dvaput dnevno na 36 bolesnika u dobi od 2 do 11 godina.
Remember to have your liver blood test every month.
Sjetite se svaki mjesec napraviti nalaze funkcije jetre.
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.
U studiji AC-052-373 (FUTURE 3) uz primjenu tableta za oralnu suspenziju, izloženost bolesnika liječenih s 2 mg/kg bosentana dvaput dnevno bila je usporediva onoj u studiji FUTURE 1.
There is limited experience with abrupt discontinuation of STAYVEER in patients with PAH.
Postoji ograničeno iskustvo s naglim prekidom primjene STAYVEERA u bolesnika s PAH-om.
Treatment effects
Učinci liječenja
The efficacy of STAYVEER has not been established in patients with severe PAH.
Djelotvornost STAYVEERA nije utvrđena u bolesnika s teškim PAH-om.
In addition, an increased incidence of elevated aminotransferases was observed in patients receiving concomitant therapy.
Primijećena je i povećana učestalost povišenih vrijednosti aminotransferaza u bolesnika koji su istodobno dobivali ta dva lijeka.
Tadalafil: Bosentan (125 mg twice daily) reduced tadalafil (40 mg once per day) systemic exposure by 42% and Cmax by 27% following multiple dose co-administration.
Tadalafil: bosentan (125 mg dva puta dnevno) smanjio je sistemsko izlaganje tadalafila (40 mg jednom na dan) za 42% te vrijednost Cmax za 27% nakon istodobne primjene višestruke doze.