FrancophonIA/ELRC3.0 huggingface dataset:
English: Time to First Clinical Failure Event (Adjudicated) Clinical failure, no. (%)
Croatian: Vrijeme do prvog događaja kliničkog neuspjeha (ocijenjen događaj) Klinički neuspjeh, br. (%)
English: The usual dose of Volibris is one 5 mg tablet, once a day.
Croatian: Uobičajena doza lijeka Volibris je jedna tableta od 5 mg, jednom dnevno.
English: Always take this medicine exactly as your doctor or pharmacist has told you to.
Croatian: Kako uzimati Volibris Uvijek uzmite ovaj lijek točno onako kako Vam je rekao liječnik ili ljekarnik.
English: Due to the class primary pharmacologic effect, a large single dose of ambrisentan (i.e. an overdose) could lower arterial pressure and have the potential for causing hypotension and symptoms related to vasodilation.
Croatian: Obzirom na primarni farmakološki učinak skupine, jedna velika doza ambrisentana (tj. predoziranje), mogla bi sniziti arterijski tlak i prouzročiti hipotenziju i simptome vezane uz vazodilataciju.
English: Volibris widens the pulmonary arteries, making it easier for the heart to pump blood through them.
Croatian: Volibris proširuje plućne arterije što srcu olakšava pumpanje krvi kroz njih.
English: In healthy volunteers, single doses of 50 and 100 mg (5 to 10 times the maximum recommended dose) were associated with headache, flushing, dizziness, nausea and nasal congestion.
Croatian: U zdravih dobrovoljaca, primjena pojedinačne doze od 50 i 100 mg (5 i 10 puta više od maksimalne preporučene doze), bila je povezana s glavoboljom, crvenilom uz osjećaj vrućine, omaglicom,
English: Co. Durham DL12 8DT United Kingdom
Croatian: Durham DL12 8DT Ujedinjeno Kraljevstvo
English: PVC/PVDC/aluminium foil blisters.
Croatian: Blisteri od PVC/PVDC/aluminijske folije.
English: In the ARIES-E open label long term extension study, the 2 year risk of developing serum aminotransferase elevations >3xULN in patients treated with ambrisentan was 3.9%.
Croatian: U otvorenom dugoročnom produženom ispitivanju ARIES-E, dvogodišnji rizik od razvoja povećanih serumskih razina aminotransferaze >3xGGN u bolesnika liječenih ambrisentanom bio je 3,9%.
English: In both studies, ambrisentan was added to patients' supportive/background medication, which could have included a combination of digoxin, anticoagulants, diuretics, oxygen and vasodilators (calcium channel blockers, ACE inhibitors).
Croatian: U oba ispitivanja ambrisentan je pridodan suportivnim/postojećim lijekovima, koji su mogli uključivati kombinaciju digoksina, antikoagulansa, diuretika, kisika i vazodilatatora (blokatori kalcijskih kanala, ACE inhibitori).
English: Other medicines and Volibris Tell your doctor or pharmacist if you're taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: The primary endpoint was the time to first occurrence of a clinical failure event, defined as: - death, or - hospitalisation for worsening PAH, - disease progression; - unsatisfactory long-term clinical response.
Croatian: Primarna mjera ishoda bilo je vrijeme do prvog nastupa događaja kliničkog neuspjeha, koji se definirao kao: - smrt ili - hospitalizacija zbog pogoršanja PAH-a - progresija bolesti
English: A study of 492 patients (ambrisentan N=329, placebo N=163) with idiopathic pulmonary fibrosis (IPF), 11% of which had secondary pulmonary hypertension (WHO group 3), has been conducted, but was terminated early when it was determined that the primary efficacy endpoint could not be met (ARTEMIS-IPF study).
Croatian: Provođeno je ispitivanje na 492 bolesnika (ambrisentan N=329, placebo N=163) s idiopatskom plućnom fibrozom (IPF), od kojih je 11% imalo sekundarnu plućnu hipertenziju (SZO skupina 3), no isto je ranije prekinuto kada je utvrđeno da se primarni ishod djelotvornosti neće postići (ispitivanje
English: The safety of ambrisentan has been evaluated as monotherapy and/or in combination in clinical trials of more than 1200 patients with PAH (see section 5.1).
Croatian: Sigurnost ambrisentana ocjenjivala se u monoterapiji i/ili kombiniranoj terapiji u kliničkim ispitivanjima provedenima u više od 1200 bolesnika s PAH-om (vidjeti dio 5.1).
English: A statistically significant increase (3.41 ± 6.96) was observed for the combined dose group in the physical functioning scale of the SF-36 Health Survey compared with placebo (-0.20 ± 8.14, p=0.005).
Croatian: Statistički značajan porast (3,41 ± 6,96) za skupinu s kombiniranim dozama, u ljestvici tjelesne sposobnosti u 'SF-36 Health Survey', zabilježen je u odnosu na placebo (-0,20 ± 8,14, p=0,005).
English: Due to the mechanism of action, an overdose of ambrisentan could potentially result in hypotension (see section 5.3).
Croatian: Obzirom na mehanizam djelovanja, predoziranje ambrisentanom može potencijalno rezultirati i hipotenzijom (vidjeti dio 5.3).
English: Multiple doses of ambrisentan resulted in slight increases in digoxin AUC0-last and trough concentrations, and a 29% increase in digoxin Cmax.
Croatian: Višestruke doze ambrisentana rezultirale su blagim povećanjem AUC0-kraj i vršnih koncentracija te 29%-nim povećanjem Cmax za digoksin.
English: 1 See section ‘Description of selected adverse reactions'.
Croatian: NP - nije prijavljeno 1 vidjeti dio 'Opis odabranih nuspojava'
English: Uncommon3, 8
Croatian: manje često3, 8
English: • Patient reminder card
Croatian: • Kartica s podsjetnikom za bolesnika
English: Volibris tablets contain lactose.
Croatian: Volibris tablete sadrže laktozu.
English: Ambrisentan also undergoes oxidative metabolism mainly by CYP3A4 and to a lesser extent by CYP3A5 and CYP2C19 to form 4-hydroxymethyl ambrisentan (21%) which is further glucuronidated to 4-hydroxymethyl ambrisentan glucuronide (5%).
Croatian: Ambrisentan se također metabolizira oksidativnim metabolizmom uglavnom putem CYP3A4, a manje putem CYP3A5 i CYP2C19 do 4-hidroksimetil ambrisentana (21%), koji se potom metabolizira glukuronidacijom do 4hidroksimetil ambrisentan glukuronida (5%).
English: Information from longer term non-placebo controlled studies (ARIES-E and AMBITION (combination with tadalafil)) is also included below.
Croatian: U nastavku se navode i informacije iz dugoročnijih ispitivanja koja nisu bila kontrolirana placebom (ARIES-E i AMBITION [kombinacija s tadalafilom]).
English: Two randomised, double-blind, multi-centre, placebo controlled, Phase 3 pivotal studies were conducted (ARIES-1 and 2).
Croatian: Klinička djelotvornost i sigurnost Provedena su dva randomizirana, dvostruko slijepa, multicentrična, placebom kontrolirana ključna ispitivanja faze 3 (ARIES-1 i 2).
English: • if you have liver disease.
Croatian: • ako bolujete od bolesti jetre.
English: Adverse reaction frequency categories assigned based on clinical trial experience may not reflect the frequency of adverse events occurring during normal clinical practice.
Croatian: Učestalost štetnih događaja temeljenih na iskustvima kliničkih ispitivanja ne odražavaju nužno učestalost nuspojava koje se susreću tijekom uobičajene kliničke prakse.
English: In addition to the above, except abnormal blood test results for liver function:
Croatian: Dodatno uz gore navedene nuspojave (osim poremećenih nalaza krvnih pretraga za funkciju jetre):
English: Volibris tablets contain lecithin derived from soya.
Croatian: Volibris tablete sadrže lecitin koji se dobiva iz soje.
English: Patients enrolled had IPAH or PAH associated with connective tissue disease (PAH-CTD).
Croatian: Uključeni bolesnici su bolovali od IPAHa ili PAH-a povezanog s bolešću vezivnog tkiva (PAH-CTD).
English: 30x1 film-coated tablets.
Croatian: 30x1 filmom obložena tableta
English: If a patient is hypersensitive to soya, ambrisentan must not be used (see section 4.3).
Croatian: Ako je bolesnik preosjetljiv na soju, ambrisentan se ne smije primjenjivati (vidjeti dio 4.3).
English: In combination with tadalafil (another PAH medicine) In addition to the above:
Croatian: U kombinaciji s tadalafilom (još jednim lijekom za PAH)
English: Time to First Hospitalisation for Worsening PAH (Adjudicated) First hospitalisation, no.
Croatian: Vrijeme do prve hospitalizacije zbog pogoršanja PAH-a (ocijenjen događaj) Prva hospitalizacija, br. (%)
English: Treatment with ambrisentan led to a statistically significant improvement in Borg Dyspnea Index (BDI) at week 12 (placebo-adjusted BDI of -1.1 (95% CI: -1.8 to -0.4; p=0.019; combined dose group)).
Croatian: Liječenje ambrisentanom je dovelo do statistički značajnog poboljšanja u 'Borg Dyspnea Index' (BDI) u 12-tom tjednu (placebo prilagođen BDI -1,1 (95% CI: -1,8 do -0,4; p=0,019; skupina kombiniranih doza).
English: Immune system disorders Hypersensitivity reactions (e.g. angioedema, rash, pruritus)
Croatian: Poremećaji imunološkog sustava reakcije preosjetljivosti (npr. angioedem, osip, svrbež)
English: 3 Data derived from routine pharmacovigilance surveillance and frequencies based on placebocontrolled clinical trial experience.
Croatian: 3 podaci dobiveni tijekom rutinskog farmakovigilancijskog praćenja i učestalost temeljena na iskustvu iz placebom kontroliranog kliničkog ispitivanja
English: If a clinically significant decrease in haemoglobin or haematocrit is observed, and other causes have been excluded, dose reduction or discontinuation of treatment should be considered.
Croatian: Ukoliko se zapazi klinički značajno smanjenje koncentracija hemoglobina ili hematokrita, a drugi su uzroci isključeni, treba razmotriti smanjenje doze ili prekid liječenja.
English: Idiopathic or heritable PAH was the most common aetiology in the study population (56%), followed by PAH due to connective tissue disorders (37%), PAH associated with drugs and toxins (3%), corrected simple congenital heart disease (2%), and HIV (2%).
Croatian: (56%), a nakon njega su slijedili PAH povezan s bolešću vezivnog tkiva (37%), PAH povezan s lijekovima i toksinima (3%), korigirana jednostavna prirođena srčana bolest (2%) i HIV (2%).
English: PHARMACEUTICAL FORM AND CONTENTS 10x1 film-coated tablets.
Croatian: OBLIK I SADRŽAJ 10x1 filmom obložena tableta
English: Monotherapy Pooled (N=247)
Croatian: Objedinjene monoterapije (N=247)
English: This is a very common side effect that may affect more than one in 10 people
Croatian: Ovo je vrlo česta nuspojava koja se može javiti u više od 1 na 10 osoba.
English: Baseline values of hepatic aminotransferases (aspartate aminotransferases (AST) and/or alanine aminotransferases (ALT))>3xULN (see sections 4.2 and 4.4).
Croatian: Početna vrijednost jetrenih aminotransferaza (aspartat aminotransferaze (AST) i/ili alanin aminotransferaze (ALT)) >3 x GGN (vidjeti dijelove 4.2 i 4.4).
English: Manufacturer Aspen Bad Oldesloe GmbH Industriestrasse 32-36 D-23843 Bad Oldesloe Germany
Croatian: Aspen Bad Oldesloe GmbH Industriestrasse 32-36
English: → It is important that you have these regular blood tests for as long as you are taking Volibris.
Croatian: →Važno je da redovito provodite krvne pretrage za vrijeme liječenja lijekom Volibris.
English: There is no experience in PAH patients of ambrisentan at daily doses greater than 10 mg.
Croatian: Nema iskustava u bolesnika s PAH-om s primjenom doza ambrisentana viših od 10 mg dnevno.
English: A multicenter, double-blind, active comparator, event-driven, Phase 3 outcome study (AMB112565/AMBITION) was conducted to assess the efficacy of initial combination of ambrisentan and tadalafil vs. monotherapy of either ambrisentan or tadalafil alone, in 500 treatment naive PAH patients, randomised 2:1:1, respectively.
Croatian: Provedeno je multicentrično, dvostruko slijepo, aktivnim lijekom kontrolirano ispitivanje ishoda faze III vođeno događajima (AMB112565/AMBITION) radi ocjenjivanja djelotvornosti početne kombinirane terapije ambrisentom i tadalafilom u odnosu na monoterapiju ambrisentanom ili tadalafilom u 500 prethodno neliječenih bolesnika s PAH-om, koji su bili randomizirani u omjeru
English: • Ambrisentan blocks the ETA receptor subtype, localized predominantly on vascular smooth muscle cells and cardiac myocytes.
Croatian: • Ambrisentan blokira ETA podvrstu receptora, smještenu uglavnom na glatkim mišićnim stanicama krvnih žila i kardiomiocitima.
English: → Don't breast-feed while you're taking Volibris.
Croatian: Nemojte dojiti dijete dok uzimate Volibris.
English: In placebo controlled clinical trials of 12 weeks duration mean reduction in systolic and diastolic blood pressures from base line to end of treatment were 3mm Hg and 4.2 mm Hg respectively.
Croatian: U 12-tjednim placebom kontroliranim kliničkim ispitivanjima, srednja vrijednost smanjenja sistoličkog odnosno dijastoličkog krvnog tlaka od početnih vrijednosti pa do kraja terapije bila je 3 mmHg odnosno 4,2 mmHg.
English: The mean decreases in systolic and diastolic blood pressures persisted for up to 4 years of treatment with ambrisentan in the long term open label ARIES E study.
Croatian: Srednje vrijednosti smanjenja sistoličkog i dijastoličkog krvnog tlaka zadržane su do 4 godine liječenja ambrisentanom u dugoročnom otvorenom ispitivanju ARIES E.
English: ARIES-2 included 192 patients and compared ambrisentan 2.5 mg and 5 mg with placebo.
Croatian: ARIES-2 je provedeno na 192 bolesnika, a uspoređivan je ambrisentan od 2,5 mg i 5 mg s placebom.
English: Data derived from routine pharmacovigilance surveillance, frequencies based on statistical modelling of placebocontrolled clinical trial data.
Croatian: Podaci su dobiveni tijekom rutinskog farmakovigilancijskog praćenja, učestalost je temeljena na statističkom modeliranju podataka iz placebo kontroliranog kliničkog ispitivanja
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Croatian: nedostatka Lapp laktaze ili malapsorpcije glukoze-galaktoze, ne bi trebali upotrebljavati ovaj lijek.
English: The other ingredients are: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, talc (E553b), titanium dioxide (E171), macrogol 3350, lecithin (soya) (E322) and Allura red AC Aluminium Lake (E129).
Croatian: Drugi sastojci su: laktoza hidrat, mikrokristalična celuloza, umrežena karmelozanatrij, magnezijev stearat, poli(vinilni alkohol), talk (E553b), titanijev dioksid (E171), makrogol 3350, lecitin (soja) (E322) i boja Allura red AC Aluminium Lake (E129).
English: Volibris is supplied as 5 mg and 10 mg film-coated tablets in unit dose blister packs of 10x1 or 30x1 tablets.
Croatian: Volibris je dostupan u obliku filmom obloženih tableta od 5 mg i 10 mg u blister pakiranjima djeljivima na jedinične doze s 10x1 ili 30x1 tabletom.
English: • liver injury • inflammation of the liver caused by the body's own defences (autoimmune hepatitis)
Croatian: • upala jetre koju uzrokuje vlastiti imunološki sustav (autoimuni hepatitis).
English: In the post-marketing period, cases of anaemia requiring blood cell transfusion have been reported (see section 4.4).
Croatian: U razdoblju nakon stavljanja lijeka u promet, prijavljeni su slučajevi anemije koja je zahtijevala transfuziju krvnih stanica (vidjeti dio 4.4).
English: Peel back the outer layer: starting at the coloured corner, lift and peel over the pocket.
Croatian: Odlijepite vanjski sloj: počnite od obojanog kuta, podignite i odlijepite džep.
English: Women receiving ambrisentan must be advised of the risk of foetal harm and alternative therapy initiated if pregnancy occurs (see sections 4.3, 4.4 and 5.3).
Croatian: Žene koje primaju ambrisentan mora se upozoriti na rizik od fetalnih oštećenja, te se u slučaju trudnoće mora započeti s alternativnim oblicima liječenja (vidjeti dijelove 4.3, 4.4 i 5.3).
English: Across the 12 week placebo controlled Phase 3 clinical studies, mean haemoglobin concentrations decreased for patients in the ambrisentan groups and were detected as early as week 4 (decrease by 0.83 g/dL); mean changes from baseline appeared to stabilise over the subsequent 8 weeks.
Croatian: Tijekom 12 tjedana placebom kontrolirane faze 3 kliničkih ispitivanja, srednja vrijednost koncentracije hemoglobina za bolesnike u grupi na ambrisentanu se smanjila (smanjenje za 0,83 g/dl), a zamijećena je već u četvrtom tjednu ispitivanja; srednje vrijednosti odstupanja od osnovne vrijednosti su se stabilizirale tijekom sljedećih 8 tjedana.
English: Ambrisentan in combination with tadalafil When used in combination with tadalafil, Volibris should be titrated to 10 mg once daily.
Croatian: Kada se primjenjuje u kombinaciji s tadalafilom, dozu lijeka Volibris treba titrirati do 10 mg jednom na dan.
English: Co-administration of ambrisentan with a phosphodiesterase inhibitor, either sildenafil or tadalafil (both substrates of CYP3A4) in healthy volunteers did not significantly affect the pharmacokinetics of the phosphodiesterase inhibitor or ambrisentan (see section 5.2).
Croatian: Inhibitori fosfodiestraze Istovremena primjena ambrisentana i inhibitora fosfodiesteraze kao što su sildenafil ili tadalafil (oba supstrati CYP3A4) u zdravih dobrovoljaca nije značajno utjecala na farmakokinetiku inhibitora fosfodiesteraze ili ambrisentana (vidjeti dio 5.2).
English: In vitro data indicate that ambrisentan at 300 μM resulted in less than 50 % inhibition of UGT1A1, UGT1A6, UGT1A9, UGT2B7 (up to 30%) or of cytochrome P450 enzymes 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4 (up to 25%).
Croatian: In vitro podaci pokazuju da je ambrisentan u koncentraciji od 300 µM uzrokovao manje nego 50%-tnu inhibiciju UGT1A1, UGT1A6, UGT1A9, UGT2B7 (do 30%) te enzima citokroma P450: 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 i 3A4 (do 25%).
English: Idiopathic pulmonary fibrosis (IPF), with or without secondary pulmonary hypertension (see section
Croatian: Idiopatska plućna fibroza (IPF) sa ili bez sekundarne plućne hipertenzije (vidjeti dio 5.1).
English: (ARIES-C and post marketing)
Croatian: Ambrisentan (ARIES-C i nakon stavljanja lijeka u promet)
English: Patients should be monitored for signs of hepatic injury and monthly monitoring of ALT and AST is recommended.
Croatian: Potrebno je pratiti znakove oštećenja jetre kod bolesnika te se preporučuje određivanje AST i ALT
English: If patients develop sustained, unexplained, clinically significant ALT and/or AST elevation, or if ALT and/or AST elevation is accompanied by signs or symptoms of hepatic injury (e.g. jaundice), ambrisentan therapy should be discontinued.
Croatian: Ukoliko se zabilježi trajno, neobjašnjeno, klinički značajno povišenje AST i/ili ALT ili je ono praćeno kliničkim znakovima i simptomima jetrenog oštećenja (npr. žutica), terapiju ambrisentanom treba prekinuti.
English: Ambrisentan does not inhibit or induce phase I or II drug metabolising enzymes at clinically relevant concentrations in in vitro and in vivo non-clinical studies, suggesting a low potential for ambrisentan to alter the profile of medicinal products metabolised by these pathways.
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Ambrisentan ne inhibira niti inducira enzime faze I ili II metabolizma lijekova u klinički značajnim koncentracijama u in vitro i in vivo nekliničkim ispitivanjima, što sugerira malu sposobnost ambrisentana u mijenjanju svojstva lijekova koji se metaboliziraju na ovaj način.
English: Tadalafil monotherapy (N=121)
Croatian: Monoterapija tadalafilom (N=121)
English: 8 Cases of autoimmune hepatitis, including cases of exacerbation of autoimmune hepatitis, and hepatic injury have been reported during ambrisentan therapy.
Croatian: 8 prijavljeni su slučajevi autoimunog hepatitisa, uključujući slučajeve egzacerbacije autoimunog hepatitisa, i oštećenje jetre tijekom terapije ambrisentanom
English: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Magnesium stearate
Croatian: Jezgra tablete laktoza hidrat celuloza, mikrokristalična karmelozanatrij, umrežena magnezijev stearat
English: Tel.: + 48 (0)22 576 9000
Croatian: Services Sp. z o.o. Tel.: + 48 (0)22 576 9000
English: How much Volibris to take
Croatian: Koliko lijeka Volibris uzeti
English: Administration of ambrisentan to female rats from late-pregnancy through lactation caused adverse events on maternal behaviour, reduced pup survival and impairment of the reproductive capability of the offspring (with observation of small testes at necropsy), at exposure 3-fold the AUC at the maximum recommended human dose.
Croatian: Primjena ambrisentana na ženkama štakora tijekom kasne trudnoće i laktacije uzrokovala je štetne događaje u vidu promjena u ponašanju majke, smanjenja preživljenja mladunčadi i poremećaja reproduktivne sposobnosti potomstva (uz nalaz smanjenih testisa na nekropsiji), pri izloženosti kod
English: The primary endpoint defined for the Phase 3 studies was improvement in exercise capacity assessed by change from baseline in 6 minute walk distance (6MWD) at 12 weeks.
Croatian: Primarni ishod ispitivanja definiran za fazu 3 ispitivanja, bio je poboljšanje podnošenja napora procijenjeno nakon 12 tjedana testom šestominutnog hoda (6MWD; engl.
English: Volibris treatment must not be initiated in women of child-bearing potential unless the result of a pretreatment pregnancy test is negative and reliable contraception is practiced.
Croatian: Liječenje lijekom Volibris se ne smije započeti u žena reproduktivne dobi ukoliko rezultat prethodno učinjenog testa na trudnoću nije negativan i ukoliko žena ne koristi pouzdane metode kontracepcije.
English: Therefore hepatic aminotransferases (ALT and AST) should be evaluated prior to initiation of ambrisentan and treatment should not be initiated in patients with baseline values of ALT and/or AST >3xULN (see section 4.3).
Croatian: Stoga je potrebno prekontrolirati vrijednosti jetrenih aminotransferaza (AST i ALT) prije uvođenja ambrisentana te liječenje ne treba započinjati u bolesnika u kojih su početne vrijednosti ALT i/ili AST >3xGGN (vidjeti dio 4.3).
English: NT-proBNP (% reduction)
Croatian: Nterminal proBrain Natriuremic Peptide) (% smanjenja)
English: How to take Volibris
Croatian: Kako uzeti Volibris
English: However, multiple doses of ambrisentan had no clinically relevant effect on cyclosporine A exposure, and no dose adjustment of cyclosporine A is warranted.
Croatian: Međutim, višekratne doze ambrisentana nisu imale relevantan klinički značaj na izloženost ciklosporinu A, te nije sigurna potreba prilagodbe doze ciklosporina A.
English: Efficacy of combination therapy on the primary endpoint was consistent on the comparison to individual monotherapy and across the subgroups of age, ethnic origin, geographical region, aetiology (IPAH /hPAH and PAH-CTD).
Croatian: Djelotvornost kombinirane terapije s obzirom na primarnu mjeru ishoda bila je konzistentna kada se uspoređivala s pojedinom monoterapijom, kao i u podskupinama prema dobi, etničkom podrijetlu, geografskoj regiji i etiologiji
English: INFORMATION IN BRAILLE volibris 10 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU volibris 10 mg
English: In vitro, ambrisentan has no inhibitory effect on human transporters at clinically relevant concentrations, including the P-glycoprotein (Pgp), breast cancer resistance protein (BCRP), multidrug resistance related protein 2 (MRP2), bile salt export pump (BSEP), organic anion transporting polypeptides (OATP1B1 and OATP1B3) and the sodium-dependent taurocholate co-transporting polypeptide (NTCP).
Croatian: In vitro, ambrisentan u klinički značajnim koncentracijama nema inhibitorni učinak na humane prijenosnike, uključujući P-glikoprotein (Pgp), protein koji uzrokuje rezistenciju raka dojke na lijekove (BCRP, engl. breast cancer resistance protein), protein povezan s rezistencijom na više lijekova 2 (MRP2, engl. multi-drug resistance related protein 2), pumpu za izlučivanje žučnih soli (BSEP, engl. bile salt export pump), polipeptide koji transportiraju organske anione (OATP1B1 i OATP1B3, engl. organic anion transporting polypeptide) i o natriju ovisni kotransportni polipeptid za taurokolat (NTCP, engl. sodium-dependent taurocholate co-transporting polypeptide).