natgillin/translations-raw huggingface dataset:
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.
U toj studiji učestalost hospitalizacije zbog kroničnog zatajenja srca tijekom prvih 4-8 tjedana liječenja bosentanom bila je povećana, što je možda bio rezultat zadržavanja tekućine.
At adult age (Day 69 post partum), no effects of bosentan were detected at 1.3 (males) and 2.6 (females) times the therapeutic exposure in children with PAH.
U odrasloj dobi (69. postpartalni dan) nisu zabilježeni učinci bosentana pri izloženosti 1,3 puta (mužjaci) i 2,6 puta (ženke) većoj od terapijske izloženosti u djece s PAH-om.
In adult patients, the exposure to the active metabolite is greater than in healthy subjects.
Izloženost aktivnom metabolitu veća je kod odraslih bolesnika nego kod zdravih osoba.
An increased long-term risk of hepatic toxicity and haematological adverse events cannot be excluded when bosentan is used in combination with antiretroviral medicinal products.
Povećan dugoročan rizik od hepatotoksičnosti i hematoloških nuspojava ne može se isključiti kod istodobne primjene bosentana i antiretrovirusnih lijekova.
Elevations in liver aminotransferases, i.e., aspartate and alanine aminotransferases (AST and/or ALT), associated with bosentan are dose dependent.
Povišenje razine jetrenih aminotransferaza, tj. aspartat- i alanin-aminotransferaze (AST i/ili ALT) ovisno je o dozi bosentana.
No specific studies have been conducted to assess the direct effect of STAYVEER on the ability to drive and use machines.
Nisu provedene specifične studije za procjenu direktnog utjecaja STAYVEERA na sposobnost upravljanja vozilima i rada sa strojevima.
Because of possible hormonal contraception failure during STAYVEER treatment, and also bearing in mind the risk that pulmonary hypertension severely deteriorates with pregnancy, monthly pregnancy tests during treatment with STAYVEER are recommended to allow early detection of pregnancy.
Zbog mogućeg zatajenja hormonske kontracepcije tijekom liječenja STAYVEEROM te uzimajući u obzir da u trudnoći dolazi do teškog pogoršanja plućne hipertenzije, preporučuju se mjesečni testovi na trudnoću tijekom liječenja STAYVEEROM kako bi se trudnoća rano otkrila.
If you stop taking STAYVEER
Ako prestanete uzimati STAYVEER
An interaction study between bosentan and lopinavir+ritonavir in healthy subjects showed increased plasma concentrations of bosentan, with the maximum level during the first 4 days of treatment (see section 4.5).
Studija interakcije između bosentana i lopinavira te ritonavira na zdravim dobrovoljcima je pokazala povišene koncentracije bosentana u plazmi s maksimalnom razinom tijekom prva 4 dana terapije (vidjeti dio 4.5).
Consequently, bosentan is not expected to increase the plasma concentrations of medicinal products metabolised by these isoenzymes.
Stoga se ne očekuje da bosentan povećava koncentracije u plazmi lijekova koje metaboliziraju ti izoenzimi.
After co-administration of bosentan for 9.5 days, the plasma exposures to lopinavir and ritonavir decreased to a clinically non-significant extent (by approximately 14% and 17%, respectively).
Nakon istodobne primjene bosentana kroz 9,5 dana, izloženost lopinaviru i ritonaviru u plazmi se smanjila u klinički neznačajnom opsegu (približno 14% odnosno 17%).
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.
Iz istog razloga ne preporučuje se istodobna primjena jakog inhibitora CYP3A4 (poput ketokonazola, itrakonazola ili ritonavira) i inhibitora CYP2C9 (poput vorikonazola) sa STAYVEEROM.
These effects are mediated by endothelin binding to ETA and ETB receptors located in the endothelium and vascular smooth muscle cells.
Do tih učinaka dolazi uslijed vezanja endotelina za receptore ETA i ETB koji se nalaze u endotelu i glatkim mišićnim stanicama krvnih žila.
This is most likely due to induction of CYP3A4 by bosentan.
To je najvjerojatnije posljedica indukcije CYP3A4 uz pomoć bosentana.
Plasma concentrations of bosentan metabolites increased about 2-fold in these patients as compared with subjects with normal renal function.
Koncentracije metabolita bosentana u plazmi povećale su se otprilike dvostruko u tih bolesnika u odnosu na bolesnike s normalnom bubrežnom funkcijom.
In the event of associated clinical symptoms of liver injury, i.e., nausea, vomiting, fever, abdominal pain, jaundice, unusual lethargy or fatigue, flu-like syndrome (arthralgia, myalgia, fever), treatment must be stopped and re-introduction of STAYVEER is not to be considered.
U slučaju drugih kliničkih simptoma oštećenja jetre, tj. mučnine, povraćanja, vrućice, bolova u abdomenu, žutice, neuobičajene slabosti ili umora, simptoma sličnih gripi (artralgija, mialgija, vrućica), liječenje treba prekinuti bez razmatranja ponovnog liječenja STAYVEEROM.
At study start, less than half of the patients included (45.3% [29/64]) had bosentan treatment alone not combined with other PAH medication.
Na početku studije manje od polovice uključenih bolesnika (45,3% [29/64]) liječeno je bosentanom u monoterapiji, bez kombinacije s drugim lijekovima za PAH.
Treatment with bosentan led to a WHO functional class improvement in 42.4% of patients (placebo 30.4%).
Liječenje bosentanom dovelo je do poboljšanja WHO funkcionalnog stupnja u 42,4% bolesnika (i u 30,4% bolesnika koji su dobivali placebo).
• Elevated liver function tests with hepatitis (inflammation of the liver) including possible exacerbation of underlying hepatitis and/or jaundice (yellowing of the skin or the whites of the eyes)
• Povišene vrijednosti testova jetrene funkcije s hepatitisom (upala jetre), uključujući i moguće pogoršanje podležećeg hepatitisa, i/ili žuticom (žutilo kože ili bjeloočnica)
There is no specific clinical experience in patients undergoing dialysis.
Nema kliničkog iskustva za bolesnike na dijalizi.
Concomitant use of STAYVEER with glibenclamide, fluconazole and rifampicin is not recommended.
Istodobna primjena STAYVEERA s glibenklamidom, flukonazolom i rifampicinom se ne preporučuje.
These will be done every month for the duration of treatment with STAYVEER.
Ove pretrage provodit će se svakog mjeseca tijekom liječenja STAYVEEROM.
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.
Prilagođavanje doze varfarina i sličnih oralnih antikoagulansa nije potrebno u početku primjene bosentana, no ipak se preporuča intenzivno praćenje INR-a, osobito u početku liječenja bosentanom i kod povećanja doze.
The study was primarily designed as a pharmacokinetic study (see section 5.2), and efficacy endpoints were only exploratory.
Studija je prvenstveno zamišljena kao farmakokinetička studija (vidjeti dio 5.2) i mjere ishoda djelotvornosti bile su samo eksploratorne.
For white high-density polyethylene bottles:
Za bijele boce od polietilena visoke gustoće:
During treatment with STAYVEER, your doctor will arrange for regular blood tests to check for changes in your liver function.
Tijekom liječenja STAYVEEROM liječnik će zakazati redovite krvne pretrage kako bi provjerio promjene u funkciji jetre.
((Inside 2))
((Unutarnja str. 2))
The same recommendations apply to reintroduction of STAYVEER after treatment interruption (see section 4.4).
Iste preporuke vrijede i pri ponovnom uvođenju liječenja STAYVEEROM nakon prekida terapije (vidjeti dio 4.4).
STAYVEER 125 mg film-coated tablets EU/1/13/832/002
STAYVEER 125 mg filmom obložene tablete EU/1/13/832/002
The film-coat contains hypromellose, glycerol triacetate, talc, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172) and ethylcellulose.
Film ovojnica sadrži hipromelozu, gliceroltriacetat, talk, titanijev diokisid (E171), željezov oksid žuti (E172), željezov oksid crveni (E172) i etilcelulozu.
When administered concomitantly with lopinavir+ritonavir, or other ritonavir-boosted protease inhibitors, the patient's tolerability of STAYVEER should be monitored.
Kada se STAYVEER primjenjuje u kombinaciji sa lopinavirom + ritonavirom ili nekim drugim inhibitorima proteaza pojačanih ritonavirom, treba pratiti bolesnikovu podnošljivost
In a study investigating the effects of bosentan on testicular function in male PAH patients, 8 out of 24 patients showed a decreased sperm concentration from baseline of at least 42% after 3 or 6 months of treatment with bosentan.
U ispitivanju koje je istraživalo učinke bosentana na funkciju testisa muških bolesnika s PAH-om, u 8 od 24 bolesnika zabilježeno je smanjenje koncentracije spermija od početne vrijednosti od najmanje 42% nakon 3 ili 6 mjeseci liječenja bosentanom.
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.
Bolesnici su prema WHO funkcionalnom stupnju klasificirani u stupanj I (n = 19, 29%), stupanj II (n = 27, 42%) ili stupanj III (n = 18, 28%) na početku ispitivanog liječenja.
However, STAYVEER can induce hypotension (decrease of your blood pressure) which can make you feel dizzy, affect your vision and affect your ability to drive and use machines.
Ipak, STAYVEER može uzrokovati hipotenziju (pad krvnog tlaka) što može uzrokovati osjećaj omaglice, utjecati na vaš vid i utjecati na vašu sposobnost upravljanja vozilima i rada sa strojevima.
In animal models of pulmonary hypertension, chronic oral administration of bosentan reduced pulmonary vascular resistance and reversed pulmonary vascular and right ventricular hypertrophy.
Na životinjskim modelima plućne hipertenzije, kronična oralna primjena bosentana smanjila je plućni krvožilni otpor i zaustavila hipertrofiju plućnih žila i desnog ventrikula.
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).
Epoprostenol: ograničeni podaci dobiveni iz studije (AC-052-356 [BREATHE-3]) u kojoj je 10 pedijatrijskih bolesnika dobilo kombinaciju bosentana i epoprostenola pokazuju da su i nakon primjene jednokratnih i višekratnih doza vrijednosti Cmax i AUC bosentana bile slične u bolesnika sa ili bez kontinuirane infuzije epoprostenola (vidjeti dio 5.1).
Dyspnoea measurement during walk tests showed an improvement in bosentan-treated patients.
Mjerenje dispneje tijekom testova hodanja pokazalo je poboljšanje u bolesnika koji su dobivali bosentan.
In study AC-052-391 (FUTURE 4) conducted in neonates, bosentan concentrations increased slowly and continuously over the first dosing interval, resulting in low exposure (AUC0-12 in whole blood:
U studiji AC-052-391 (FUTURE 4) provedenoj na novorođenčadi, koncentracije bosentana rasle su polako i neprekidno tijekom prvog intervala doziranja dovodeći do niske izloženosti (AUC0-12 u punoj krvi: 164 ng•h/mL, n = 11).
Abnormal liver function test (see section 4.4)
Poremećaj nalaza funkcije jetre (vidjeti dio 4.4)
• hormonal contraceptives, which are not effective as the sole method of contraception when you take STAYVEER.
• hormonske kontraceptive koji nisu učinkoviti kao jedina metoda kontracepcije kod uzimanja STAYVEERA.
((Inside 1))
((Unutarnja str. 1))
Aminotransferase elevations associated with hepatitis (including possible exacerbation of underlying hepatitis) and/or jaundice1 (see section 4.4)
Povišene razine aminotransferaze povezane s hepatitisom (uključujući moguću egzacerbaciju podležećeg hepatitisa) i/ili žuticom1 (vidjeti dio 4.4)
The average exposure to bosentan in these paediatric patients was about half the exposure in adult patients at the 125 mg twice daily maintenance dose but showed a large overlap with the exposures in adults.
Prosječna izloženost bosentanu ovih pedijatrijskih bolesnika iznosila je oko polovicu izloženosti odraslih bolesnika koji su dobivali dozu održavanja od 125 mg dvaput dnevno te je pokazalo veliko preklapanje sa izloženostima u odraslih.
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.
Dugoročna vitalnost zabilježena je za svih 235 bolesnika koji su dobivali bosentan u sklopu dvije placebom kontrolirane studije (AC-052-351 i AC-052-352) i/ili njihova dva nekontrolirana, otvorena produženja.
Liver dysfunction risk may also be increased when medicinal products that are inhibitors of the bile salt export pump, e.g., rifampicin, glibenclamide and cyclosporine A (see sections 4.3 and 4.5), are co-administered with bosentan, but limited data are available.
Rizik od poremećaja funkcije jetre može biti povećan kod istodobne primjene inhibitora crpke za izlučivanje žučnih soli, poput rifampicina, glibenklamida i ciklosporina A (vidjeti dijelove 4.3 i 4.5), s tim da su dostupni samo ograničeni podaci.
Treatment must be stopped and re-introduction of STAYVEER is not to be considered.
Liječenje treba prekinuti bez razmatranja ponovnog liječenja
A careful benefit/risk assessment should be made, taking into consideration that the liver toxicity is dose dependent (see sections 4.4 and 5.1).
Potrebno je pažljivo procijeniti omjer koristi i rizika, uzimajući u obzir da je toksično djelovanje na jetru ovisno o dozi (vidjeti dijelove 4.4 i 5.1).
Pregnancy tests
Testovi na trudnoću
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 je primijenjen jednokratno u dozi do 2400 mg u zdravih osoba te do 2000 mg dnevno tijekom 2 mjeseca u bolesnika s bolešću izuzev plućne hipertenzije.
However, STAYVEER may induce hypotension, with symptoms of dizziness, blurred vision or syncope that could affect the ability to drive or use machines.
Ipak, STAYVEER može uzrokovati hipotenziju sa simptomima omaglice, zamagljenog vida ili sinkope koji mogu utjecati na sposobnost upravljanja vozilima ili rada sa strojevima.
In the post-marketing period rare cases of liver cirrhosis and liver failure have been reported.
Tijekom postmarketinškog razdoblja zabilježeni su rijetki slučajevi ciroze jetre i zatajenja jetre.
The similarities of the pattern of malformations observed with other ET receptor antagonists and in ET knock-out mice indicate a class effect.
Sličnost u malformacijama koje su primijećene u drugih antagonista ET-receptora i u miševa bez ET-receptora (knock-out) ukazuje da je riječ o učinku iste klase.
The effect of bosentan on reduction of the number of new digital ulcers was more pronounced in patients with multiple digital ulcers.
Učinak bosentana na smanjenje broja novih ulceracija prstiju bio je više izražen u bolesnika s brojnim ulceracijama prstiju.
No evidence for acute rebound has been observed.
Nije primijećena pojava akutnog pogoršanja (rebounda).
Tell your doctor immediately if you are breast-feeding.
Odmah recite svom liječniku ako dojite.
The most serious side effects with STAYVEER are
Najozbiljnije nuspojave STAYVEERA su:
If a clinically relevant decrease in haemoglobin concentration occurs, further evaluation and investigation should be undertaken to determine the cause and need for specific treatment.
Ako dođe do klinički značajnog smanjenja koncentracije hemoglobina, treba odrediti njegov uzrok te potrebu za specifičnim liječenjem.
Do not use this medicine after the expiry date which is stated on the carton and on the blister after “EXP”.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji ili blisteru iza oznake „EXP“”.
Some patients not responding well to 125 mg twice daily of STAYVEER may slightly improve their exercise capacity when the dose is increased to 250 mg twice daily.
Kod nekih bolesnika koji ne reagiraju dobro na 125 mg STAYVEERA dvaput dnevno, može doći do blagog poboljšanja kapaciteta fizičkog opterećenja kada se doza poveća na 250 mg dvaput dnevno.
Tablets should be taken (morning and evening), swallowed with water.
Tablete treba uzeti ujutro i navečer s vodom.
Patients were divided into three body-weight groups and dosed with bosentan at approximately 2 mg/kg twice daily for 12 weeks.
Bolesnici su podijeljeni u tri skupine s obzirom na tjelesnu težinu i dobivali su bosentan u dozi od otprilike 2 mg/kg dvaput dnevno tijekom 12 tjedana.
The Kaplan-Meier event-free estimate for worsening of PAH (death, lung transplantation, or hospitalisation for PAH worsening) at 24 weeks was 96.9% and 96.7% in the twice daily and three times daily groups, respectively.
KaplanMeierova procjena preživljenja bez događaja pogoršanja PAH-a (smrt, transplantacija pluća ili hospitalizacija zbog pogoršanja PAH-a) nakon 24 tjedna bila je 96,9% u skupini koja je lijek primala dvaput dnevno i 96,7% u skupini koja je lijek primala triput dnevno.
Both glibenclamide and bosentan inhibit the bile salt export pump, which could explain the elevated aminotransferases.
Oba lijeka, glibenklamid i bosentan inhibiraju crpku za izlučivanje žučnih soli, što može objasniti povišene aminotransferaze.
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
Stoga se sami hormonski kontraceptivi, neovisno o putu primjene (tj. u oralnom, injekcijskom, transdermalnom ili implantacijskom obliku) ne smatraju pouzdanom metodom kontracepcije (vidjeti dijelove 4.4 i 4.6).
Bosentan has been shown to be teratogenic in rats at plasma levels higher than 1.5 times the plasma concentrations achieved at the therapeutic dose in humans.
Bosentan je teratogen u štakora kod koncentracija u plazmi koje su 1,5 puta veće od onih koje se postižu kod terapijskih doza u ljudi.
OUTER CARTON & BOTTLE LABEL/ BOTTLES
KUTIJA I NALJEPNICA BOCE/BOCE
No dose adjustment is required in patients undergoing dialysis (see section 5.2).
Prilagođavanje doze nije potrebno kod pacijenata na dijalizi (vidjeti dio 5.2).
Concomitant use of rifampicin and STAYVEER is not recommended.
Istodobna primjena rifampicina i STAYVEERA nije preporučljiva.
Studies in animals have shown reproductive toxicity (teratogenicity, embryotoxicity; see section 5.3).
Ispitivanja na životinjama pokazala su reproduktivnu toksičnost (teratogenost, embriotoksičnost;
• Baseline values of liver aminotransferases, i.e., aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT), greater than 3 × the upper limit of normal (ULN; see section 4.4)
• Početne vrijednosti jetrenih aminotransferaza, tj. aspartat-aminotransferaze (AST) i/ili alanin-aminotransferaze (ALT), 3 × veće od gornje granice normalnih vrijednosti (GGN; vidjeti dio 4.4) • Istovremena primjena ciklosporina A (vidjeti dio 4.5)
The combination should be used with caution.
Kod istodobne primjene potreban je oprez.
Treatment with bosentan led to a significant increase in cardiac index associated with a significant reduction in pulmonary artery pressure, pulmonary vascular resistance and mean right atrial pressure.
Liječenje bosentanom dovelo je do značajnog povećanja srčanog indeksa sa značajnim smanjenjem plućnog arterijskog tlaka, plućnog krvožilnog otpora i srednjeg tlaka u desnom atriju.
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.
Nakon 4 tjedna uzimanja bosentana 62,5 mg dvaput dnevno doze održavanja u tim studijama bile su 125 mg dvaput dnevno u AC-052-351, 125 mg dvaput dnevno i 250 mg dvaput dnevno u AC-052-352.
Syncope1, 4
Sinkopa1,4
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).
Sigurnost i podnošljivost bosentana ispitana je u eksploratornoj, nekontroliranoj 12-tjednoj studiji na 11 bolesnika s plućnom hipertenzijom kao posljedicom teške kronične opstruktivne plućne bolesti (stadij III prema klasifikaciji GOLD).
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.
Bolesnici sa suboptimalnim odgovorom na udisanje dušikovog (II) oksida (engl. inhaled nitric oxide, iNO) unatoč najmanje 4 sata neprekinutog liječenja, liječeni su bosentanom u obliku tableta za oralnu suspenziju u dozi od 2 mg/kg dvaput dnevno (N = 13) ili placebom (N = 8) putem nazogastrične sonde kao dodatnom terapijom uz iNO sve do potpunog odvikavanja od iNO ili do terapijskog neuspjeha (definiranog kao potreba za ekstrakorporalnom membranskom oksigenacijom [ECMO] ili uvođenjem alternativnog pulmonalnog vazodilatatora) i to najdulje 14 dana.
• Headache • Oedema (swelling of the legs and ankles or other signs of fluid retention)
• Edem (oticanje nogu i gležnjeva ili drugi znakovi zadržavanja tekućine)
AC-052-356 was an open-label, uncontrolled study; 10 of the 19 paediatric patients were on concomitant bosentan and epoprostenol therapy during the 12week study.
AC-052-356 bila je otvorena, nekontrolirana studija; 10 od 19 pedijatrijskih bolesnika istodobno su dobivali bosentan i epoprostenol tijekom 12 tjedana.
STAYVEER is contraindicated in patients with moderate to severe liver dysfunction (see sections 4.3, 4.4 and 5.2).
STAYVEER je kontraindiciran kod bolesnika s umjerenom do teškom disfunkcijom jetre (vidjeti dijelove 4.3, 4.4 i 5.2).
Controlled clinical study experience in this indication is limited to 6 months (see section 5.1).
Iskustvo vezano uz ovu indikaciju ograničeno je šestomjesečnim trajanjem kontrolirane kliničke studije (vidjeti dio 5.1).
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.
Prosječno povećanje srčanog indeksa u odnosu na početnu vrijednost bilo je 0,5 l/min/m2, prosječno smanjenje srednjeg plućnog arterijskog tlaka bilo je 8 mmHg, a prosječno smanjenje plućnog krvožilnog otpora bilo je 389 dyn•s•cm-5.
After 16 weeks' treatment, there were significant improvements from baseline in exercise capacity: the mean increase in 6-minute walk distance was 91.4 metres from 332.6 metres on average at baseline (p < 0.001).
Nakon 16 tjedana liječenja došlo je do znatnog poboljšanja fizičke sposobnosti u odnosu na početnu vrijednost: srednje povećanje tijekom 6-minutne postignute udaljenosti hodom bilo je 91,4 metra u odnosu na 332,6 metara koja čine prosječnu prijeđenu udaljenost prije liječenja (p<0,001).
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.
Flukonazol i drugi inhibitori i CYP2C9 i CYP3A4: istodobna primjena flukonazola, koji uglavnom inhibira CYP2C9, ali do neke mjere i CYP3A4, može dovesti do velikog povećanja koncentracije bosentana u plazmi.
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.
Otvorena, nekomparativna studija (AC-052-362 [BREATHE-4]) provedena je na 16 bolesnika s PAH-om WHO funkcionalnog stupnja III povezanim s HIV-infekcijom.
The blood concentrations of cyclosporine A (a CYP3A4 substrate) decreased by approximately 50%.
Koncentracije ciklosporina A u krvi (supstrat za CYP3A4) bile su smanjenje za približno 50%.