FrancophonIA/ELRC3.0 huggingface dataset:
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)).
Slovenian: Zdravljenje z ambrisentanom je v 12. tednu statistično pomembno izboljšalo indeks dispneje po Borgu (BDI-Borg Dyspnea Index) (na placebo prilagojeni BDI −1,1 (95-% interval zaupanja: od −1,8 do −0,4; p = 0,019; skupina s kombiniranim odmerkom)).
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2)
Slovenian: Izdaja zdravila je le na recept s posebnim režimom (glejte Priloga I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: Ninety events (27%) of IPF progression (including respiratory hospitalisations) or death were observed in the ambrisentan group compared to 28 events (17%) in the placebo group.
Slovenian: napredovanja IPF (vključno s hospitalizacijo zaradi dihalnih razlogov) ali smrti; v skupini, ki je prejemala placebo, pa so takšnih dogodkov zabeležili 28 (17 %).
English: No dose adjustment is required in patients over the age of 65 (see section 5.2).
Slovenian: Pri bolnikih, starejših od 65 let, odmerka ni treba prilagajati (glejte poglavje 5.2).
English: Co-administration of rifampicin (an inhibitor of Organic Anion Transporting Polypeptide [OATP], a strong inducer of CYP3A and 2C19, and inducer of P-gp and uridine-diphosphoglucuronosyltransferases [UGTs]) was associated with a transient (approximately 2-fold) increase in ambrisentan exposure following initial doses in healthy volunteers.
Slovenian: Sočasna uporaba rifampicina (zaviralec transportnega polipeptida organskih anionov [OATP], močan induktor CYP3A in 2C19 ter induktor P-gp in uridin-difosfo-glukuronoziltransferaz [UGT]) je bila pri zdravih prostovoljcih povezana s prehodnim (približno 2-kratnim) povečanjem izpostavljenosti ambrisentanu po prvih odmerkih.
English: Mean decreases from baseline (ranging from 0.9 to 1.2 g/dL) in haemoglobin concentrations persisted for up to 4 years of treatment with ambrisentan in the long-term open-label extension of the pivotal Phase 3 clinical studies.
Slovenian: Povprečno znižanje koncentracije hemoglobina (od 0,9 do 1,2 g/dl) v primerjavi z izhodiščem je v dolgotrajnem odprtem podaljšanju ključnih kliničnih študij 3. faze vztrajalo do 4 let zdravljenja z ambrisentanom.
English: Cmax and area under the plasma concentration-time curve (AUC) increase dose proportionally over the therapeutic dose range.
Slovenian: V območju terapevtskih odmerkov se Cmax in površina pod krivuljo plazemske koncentracije v odvisnosti od časa (AUC) povečujeta proporcionalno z odmerkom.
English: The higher dose (10 mg) was associated with a higher incidence of these adverse reactions, and peripheral oedema tended to be more severe in patients ≥65 years in short-term clinical studies (see section 4.4).
Slovenian: V kratkotrajnih kliničnih študijah je večji odmerek (10 mg) spremljala večja incidenca teh neželenih učinkov, periferni edemi pa so bili praviloma hujši pri bolnikih, starih ≥ 65 let (glejte poglavje 4.4).
English: Ambrisentan Mylan is supplied as 5 mg and 10 mg film-coated tablets in packs of 30 tablets and unit dose blister packs of 30x1 tablets.
Slovenian: Zdravilo Ambrisentan Mylan je na voljo kot 5 mg in 10 mg filmsko obložene tablete v pakiranjih po 30 tablet in v enoodmernih pretisnih omotih s 30 × 1 tableto.
English: The cumulative incidence of serum aminotransferase abnormalities >3xULN in all Phase 2 and 3 studies (including respective open label extensions) was 17 of 483 subjects over a mean exposure duration of 79.5 weeks.
Slovenian: Kumulativna pojavnost nenormalnih vrednosti serumske aminotransferaze > 3 × ZMN v vseh študijah 2. in 3. faze (vključno z zadevno odprto podaljšano fazo) je bila ugotovljena pri 17 od 483 oseb v srednjem času zdravljenja 79,5 tednov, kar pomeni 2,3 dogodka na 100 bolnikov-let („patient years“) izpostavljenosti ambrisentanu.
English: Ambrisentan is therefore contraindicated for patients with IPF with or without secondary pulmonary hypertension (see section 4.3).
Slovenian: Ambrisentan je zato kontraindiciran pri bolnikih z IPF s sekundarno pljučno hipertenzijo ali brez nje (glejte poglavje 4.3).
English: The increase in digoxin exposure observed in the presence of multiple doses of ambrisentan was not considered clinically relevant, and no dose adjustment of digoxin is warranted (see section 4.5).
Slovenian: Smatra se, da večja izpostavljenost digoksinu, opažena pri ponavljajočem se odmerku ambrisentana, ni klinično pomembna, zato odmerka digoksina ni treba prilagajati (glejte poglavje 4.5).
English: Ambrisentan is a substrate for Pgp-mediated efflux.
Slovenian: Ambrisentan je substrat iztoka, ki ga posreduje Pgp.
English: This leaflet was last revised in.
Slovenian: Navodilo je bilo nazadnje revidirano dne: {MM/LLLL}
English: →Don't stop taking Ambrisentan Mylan unless you have agreed this with your doctor.
Slovenian: Ne prenehajte z jemanjem zdravila Ambrisentan Mylan, razen če vam tako svetuje vaš zdravnik.
English: 22.75 m; 95% CI: 12.00, 33.50
Slovenian: 22,75 m; 95-% IZ: 12,00,
English: How to store Ambrisentan Mylan Contents of the pack and other information
Slovenian: Shranjevanje zdravila Ambrisentan Mylan Vsebina pakiranja in dodatne informacije
English: Patients with ALT and AST values >2xULN at baseline were also excluded.
Slovenian: Prav tako niso bili vključeni bolniki z izhodiščnimi vrednostmi ALT oz. AST > 2 × ZMN.
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.
Slovenian: Povprečno znižanje sistoličnega in diastoličnega krvnega tlaka se je v dolgotrajni odprti študiji ARIES-E ohranilo do 4 leta zdravljenja z ambrisentanom.
English: • liver problems
Slovenian: • težave z jetri,
English: Therefore, ambrisentan must not be initiated in patients with severe hepatic impairment, or clinically significant elevated hepatic aminotransferases (greater than 3 times the Upper Limit of Normal (>3xULN); see sections 4.3 and 4.4).
Slovenian: Zato se ambrisentana ne sme uvesti pri bolnikih s hudo okvaro jeter ali s klinično pomembnim zvišanjem jetrnih aminotransferaz (več kot 3-kratna vrednost zgornje meje normalne vrednosti (> 3 × ZMN); glejte poglavji 4.3 in 4.4).
English: → If you become pregnant or think that you may be pregnant while you're taking Ambrisentan Mylan, see your doctor immediately.
Slovenian: → Če med jemanjem zdravila Ambrisentan Mylan zanosite ali mislite, da ste zanosili, se nemudoma posvetujte s svojim zdravnikom.
English: In the post-marketing period, cases of anaemia requiring blood cell transfusion have been reported (see section 4.4).
Slovenian: V obdobju po prihodu zdravila na trg so bili opisani primeri anemije, ki so zahtevali transfuzijo krvnih celic (glejte poglavje 4.4).
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na tableto, kar v bistvu pomeni ‘brez natrija'.
English: → It is important that you have these regular blood tests for as long as you are taking Ambrisentan Mylan.
Slovenian: → Pomembno je, da se te krvne preiskave opravljajo redno ves čas zdravljenja z zdravilom Ambrisentan Mylan.
English: Severe hepatic impairment (with or without cirrhosis) (see section 4.2).
Slovenian: Huda okvara jeter (s cirozo ali brez nje) (glejte poglavje 4.2).
English: The magnitude of the decrease in oral clearance is modest (20-40%) in patients with moderate renal impairment and therefore is unlikely to be of any clinical relevance.
Slovenian: Pri bolnikih z zmerno okvaro ledvic je obseg zmanjšanja očistka pri peroralni uporabi zmeren (20 - 40 %) in tako je klinični pomen malo verjeten.
English: Ambrisentan was not shown to be an inhibitor of bile acid transport or to produce overt hepatotoxicity.
Slovenian: Ni bilo dokazano, da bi ambrisentan zaviral transport žolčnih kislin ali bil očitno hepatotoksičen.
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%.
Slovenian: V dolgotrajni, odprti podaljšani študiji ARIES E je bilo 2-letno tveganje za zvišanje serumske aminotransferaze na > 3-kratno ZMN pri bolnikih, ki so prejemali ambrisentan,
English: The Cmax and AUC(0-τ) of ambrisentan increased (48% and 121%, respectively) in the presence of multiple doses of cyclosporine A. Based on these changes, the dose of ambrisentan should be limited to 5 mg once daily when co-administered with cyclosporine A (see section 4.2).
Slovenian: Med uporabo večkratnih odmerkov ciklosporina A se je Cmax ambrisentana povečala za 48 % in AUC(0- τ) ambrisentana za 121 % Na podlagi teh sprememb je treba odmerek ambrisentana omejiti na 5 mg enkrat na dan, kadar se jemlje v kombinaciji s ciklosporinom A (glejte poglavje 4.2).
English: Autoimmune hepatitis (see section 4.4)
Slovenian: avtoimunski hepatitis (glejte poglavje 4.4)
English: Baseline values of hepatic aminotransferases (aspartate aminotransferases (AST) and/or alanine aminotransferases (ALT))>3xULN (see sections 4.2 and 4.4).
Slovenian: Izhodiščne vrednosti jetrnih aminotransferaz (aspartat-aminotransferaze (AST) ali alaninaminotransferaze (ALT) ali obeh) > 3 × ZMN (glejte poglavji 4.2 in 4.4).
English: Patients started on ambrisentan 5 mg and tadalafil 20 mg and were titrated to 40 mg tadalafil at week 4 and 10 mg ambrisentan at week 8, unless there were tolerability issues.
Slovenian: Bolniki so začeli zdravljenje s 5 mg ambrisentana in 20 mg tadalafila, nato pa so jim odmerek tadalafila povečali na 40 mg po 4 tednih in odmerek ambrisentana na 10 mg po 8 tednih, če ni bilo nobenih težav s prenašanjem.
English: Information from longer term non-placebo-controlled studies (ARIES-E and AMBITION
Slovenian: Podatki iz dolgotrajnejših študij, ki niso bile kontrolirane s placebom (ARIES-E in AMBITION (kombinacija s tadalafilom) so navedeni v nadaljevanju.
English: The development of testicular tubular atrophy in male animals has been linked to the chronic administration of ERAs, including ambrisentan (see section 5.3).
Slovenian: Pojav atrofije tubulov mod pri samcih so povezali s kronično uporabo ERA, vključno z ambrisentanom (glejte poglavje 5.3).
English: The selectivity of ambrisentan for the ETA over the ETB receptor is expected to retain ETB receptor mediated production of the vasodilators nitric oxide and prostacyclin.
Slovenian: Zaradi večje selektivnosti ambrisentana za receptorje ETA kot receptorje ETB pričakujemo, da se bo z receptorjem ETB posredovana tvorba vazodilatatorjev dušikovega oksida in prostaciklina ohranila.
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.
Slovenian: Zaradi primarnega farmakološkega učinka zdravil iz te skupine, se pri prevelikem enkratnem odmerku ambrisentana (to je v primeru prevelikega odmerjanja) lahko zniža arterijski krvni tlak in pojavijo hipotenzija ter simptomi s tem povezane vazodilatacije.
English: The incidence of nasal congestion was dose related during ambrisentan therapy.
Slovenian: Pojavnost nosne kongestije je bila med zdravljenjem z ambrisentanom odvisna od odmerka.
English: How much Ambrisentan Mylan to take
Slovenian: Koliko zdravila Ambrisentan Mylan vzeti
English: The primary endpoint defined for the Phase 3 studies was improvement in exercise capacity assessed by change from baseline in 6minute walk distance (6MWD) at 12 weeks.
Slovenian: Primarni opazovani dogodek študij 3. faze je bil izboljšanje telesne zmogljivosti v primerjavi z izhodiščem pri 6-minutni hoji (6MWD - 6 minute walk distance) po 12 tednih.
English: • yellowing of your skin or the whites of your eyes (jaundice)
Slovenian: • rumeno obarvanje kože in očesnih beločnic (zlatenico),
English: ARIES-1 included 201 patients and compared ambrisentan 5 mg and 10 mg with placebo.
Slovenian: Študija ARIES-1, ki je vključevala 201 bolnika, je primerjala uporabo ambrisentana v odmerku 5 mg in 10 mg s placebom.
English: Microcrystalline cellulose (E460i) Croscarmellose sodium Magnesium stearate (E570)
Slovenian: Jedro tablete laktoza mikrokristalna celuloza (E460i)natrijev karmelozat, premreženi magnezijev stearat (E570)
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%).
Slovenian: Podatki in vitro kažejo, da ambrisentan pri 300 µM v manj kot 50 % zavira izoencime UGT1A1, UGT1A6, UGT1A9, UGT2B7 (do 30 %) ali encime citokroma P450 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 in 3A4 (do 25 %).
English: Other medicines and Ambrisentan Mylan
Slovenian: Druga zdravila in zdravilo Ambrisentan Mylan
English: In vitro, ambrisentan has no inhibitory effect on human transporters at clinically relevant concentrations, including Pgp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3 and NTCP.
Slovenian: In vitro, ambrisentan v klinično pomembnih koncentracijah ne zavira humanih prenašalcev, vključno s Pgp, BRCP, MRP2, BSEP, OATP1B1, OATP1B3 in NTCP.
English: This medicinal product does not require any special storage conditions.
Slovenian: Za shranjevanje ni posebnih navodil.
English: Contains lactose and Allura red AC Aluminium Lake (E129).
Slovenian: Vsebuje laktozo in alurno rdeče AC (E129).
English: Steady-state administration of ketoconazole (a strong inhibitor of CYP3A4) did not result in a clinically significant increase in exposure to ambrisentan (see section 5.2).
Slovenian: Uporaba ketokonazola (močan zaviralec CYP3A4) v stanju dinamičnega ravnovesja ni klinično pomembno povečala izpostavljenosti ambrisentanu (glejte poglavje 5.2).
English: Odds ratio 1.56; 95% CI: 1.05,
Slovenian: 95-% IZ: 1,05,
English: Component as First Clinical Failure Event (Adjudicated) Death (all-cause) 9 (4%)
Slovenian: Komponenta kot prvi dogodek kliničnega neuspeha (presojeno) Smrt (zaradi vseh vzrokov)
English: Data derived from routine pharmacovigilance surveillance and frequencies based on placebo controlled clinical trial experience.
Slovenian: Podatki iz rednega farmakovigilančnega spremljanja in pogostnosti na podlagi izkušenj kliničnih preskušanj, kontroliranih s placebom.
English: Treatment with combination therapy resulted in a 50% risk reduction (hazard ratio [HR] 0.502; 95% CI: 0.348 to 0.724; p=0.0002) of the composite clinical failure endpoint up to final assessment visit when compared to the pooled monotherapy group [Figure 1 and Table 1].
Slovenian: Kombinirano zdravljenje je do obiska za končno oceno v primerjavi s kumulativnima skupinama z monoterapijo doseglo 50 % zmanjšanje tveganja (razmerje ogroženosti [ROg] 0,502, 95-% IZ: od 0,348 do 0,724, p = 0,0002) sestavljenega opazovanega dogodka kliničnega neuspeha [slika 1 in preglednica 1].
English: Monthly pregnancy tests during treatment with ambrisentan are recommended.
Slovenian: Med zdravljenjem z ambrisentanom priporočamo mesečno izvajanje testov za ugotavljanje nosečnosti.
English: Fifty percent of patients had increased from 5 mg to 10 mg ambrisentan during this time.
Slovenian: Med tem časom so odmerek ambrisentana s 5 mg na 10 mg povečali pri petdesetih odstotkih bolnikov.
English: If clinically significant fluid retention develops during therapy with ambrisentan, with or without associated weight gain, further evaluation should be undertaken to determine the cause, such as ambrisentan or underlying heart failure, and the possible need for specific treatment or discontinuation of ambrisentan therapy.
Slovenian: V primeru klinično pomembnega zastajanja tekočin, ki se pojavi med zdravljenjem z ambrisentanom, s posledičnim povečanjem telesne mase ali brez, je treba izvesti dodatne preiskave za ugotovitev vzroka, tako v povezavi z ambrisentanom kot osnovnim srčnim popuščanjem, in presoditi o morebitni potrebi po specifičnem zdravljenju ali ukinitvi zdravljenja z ambrisentanom.
English: Ambrisentan Mylan treatment must not be initiated in women of child-bearing potential unless the result of a pre-treatment pregnancy test is negative and reliable contraception is practiced.
Slovenian: Pri ženskah v rodni dobi se zdravljenja z zdravilom Ambrisentan Mylan ne sme uvesti, če test za ugotavljanje nosečnosti, izveden pred začetkom zdravljenja, ni negativen in ženska ne uporablja zanesljive metode kontracepcije.
English: However no testicular changes were observed in dog studies of up to 39 weeks duration at an exposure 35-fold that seen in humans based on AUC.
Slovenian: Pri študijah na psih, ki so trajale do 39 tednov, pri izpostavljenosti, ki je bila na osnovi vrednosti AUC 35-krat večja od izpostavljenosti pri človeku, sprememb na modih niso opazili.
English: It is not known whether ambrisentan is excreted in human breast milk.
Slovenian: Ni znano, če se ambrisentan izloča v materino mleko.
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).
Slovenian: In vitro ambrisentan v klinično pomembnih koncentracijah ne zavira humanih prenašalcev, vključno s P-glikoproteinom (Pgp), proteinom odpornosti na rak dojke (BCRP), proteinom 2 za odpornost na več zdravil (MRP2), iztočno črpalko žolčnih soli (BSEP), transportnim polipeptidom organskih anionov (OATP1B1 in OATP1B3) in od natrija odvisnim sotransportnim polipeptidom za tavroholat (NTCP).
English: Data derived from routine pharmacovigilance surveillance, frequencies based on statistical modelling of placebo controlled clinical trial data.
Slovenian: Podatki iz rednega farmakovigilančnega spremljanja, pogostnosti temeljijo na statističnem modeliranju podatkov iz kliničnih preskušanj, kontroliranih s placebom.
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.
Slovenian: Pri samicah podgan, ki so ambrisentan prejemale od pozne brejosti in v času laktacije, so pri izpostavljenosti, ki je bila 3-kratnik AUC pri maksimalnem priporočenem odmerku pri človeku, poročali o neželenih učinkih na vedenje mater, zmanjšanem preživetju mladičev in manjši sposobnosti za razmnoževanje mladičev (pri nekropsiji so poročali o majhnih testisih).
English: Based on the results of a population pharmacokinetic analysis in healthy volunteers and patients with PAH, the pharmacokinetics of ambrisentan were not significantly influenced by gender or age (see section 4.2).
Slovenian: Na osnovi analize rezultatov populacijske farmakokinetike pri zdravih prostovoljcih in bolnikih s PAH spol in starost ne vplivata pomembneje na farmakokinetiko ambrisentana (glejte poglavje 4.2).
English: Ambrisentan Mylan contains the active substance ambrisentan.
Slovenian: Zdravilo Ambrisentan Mylan vsebuje učinkovino ambrisentan.
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).
Slovenian: Pri zdravih prostovoljcih se pri sočasni uporabi ambrisentana z zaviralcem fosfodiesteraze, bodisi sildenafilom ali tadalafilom (oba sta substrata za CYP3A4), farmakokinetika zaviralca fosfodiesteraze ali ambrisentana ni pomembneje spremenila (glejte poglavje 5.2).
English: • itching of your skin.
Slovenian: • srbenje kože.
English: It is not known if Ambrisentan Mylan is transferred to breast milk.
Slovenian: Ni znano, če se zdravilo Ambrisentan Mylan izloča v materino mleko.
English: Warfarin also had no clinically significant effects on the pharmacokinetics of ambrisentan.
Slovenian: Tudi varfarin ni imel klinično pomembnih učinkov na farmakokinetiko ambrisentana.
English: In combination with tadalafil
Slovenian: V kombinaciji s tadalafilom
English: Ambrisentan treatment must not be initiated in women of child-bearing potential unless the result of a pre-treatment pregnancy test is negative and reliable contraception is practiced.
Slovenian: Pri ženskah v rodni dobi se zdravljenja z ambrisentanom ne sme uvesti, če test za ugotavljanje nosečnosti, izveden pred začetkom zdravljenja, ni negativen in ženska ne uporablja zanesljive metode kontracepcije.
English: Patients with significant anaemia, fluid retention or rare retinal diseases were excluded according to the investigators' criteria.
Slovenian: Po preiskovalčevih merilih niso bili vključeni bolniki s pomembno anemijo, zastajanjem tekočine ali redkimi boleznimi mrežnice.
English: Monthly pregnancy tests during treatment with ambrisentan are recommended (see sections 4.3 and 4.6).
Slovenian: Med zdravljenjem z ambrisentanom priporočamo mesečno izvajanje testov za ugotavljanje nosečnosti (glejte poglavji 4.3 in 4.6).
English: The frequency of decreased haemoglobin (anaemia) was higher with 10 mg ambrisentan.
Slovenian: Znižana koncentracija hemoglobina (anemija) je bila pogostejša pri uporabi 10 mg odmerka ambrisentana.
English: After oral administration, maximum plasma concentrations (Cmax) of ambrisentan typically occur around 1.5 hours post-dose under both fasted and fed conditions.
Slovenian: Največje plazemske koncentracije (Cmax) ambrisentana se tipično pojavijo približno 1,5 ure po peroralnem odmerku, tako pri jemanju zdravila na tešče kot po obroku.
English: • a runny nose
Slovenian: • izcedek iz nosu,
English: A multicentre, 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.
Slovenian: Izvedli so multicentrično, dvojno slepo, z dogodki vodeno študijo izidov 3. faze s primerjalno učinkovino (AMB112565/AMBITION) za oceno učinkovitosti začetne kombinacije ambrisentana in tadalafila v primerjavi z monoterapijo z enim in drugim.
English: This is a common side effect that may affect up to one in 10 people.
Slovenian: To je pogost neželen učinek, ki se lahko pojavi pri največ 1 od 10 bolnikov.
English: However, by day 8, steady state administration of rifampicin had no clinically relevant effect on ambrisentan exposure.
Slovenian: Toda po 8 dneh uporaba rifampicina v stanju dinamičnega ravnovesja ni klinično pomembno vplivala na izpostavljenost ambrisentanu.
English: Anaemia (reduced number of red blood cells)
Slovenian: Anemija (zmanjšanje števila krvnih celic)
English: • chest pain or discomfort
Slovenian: • bolečine ali nelagodje v prsih,
English: Ambrisentan in combination with tadalafil
Slovenian: Ambrisentan v kombinaciji s tadalafilom
English: • dark-coloured urine
Slovenian: • temno obarvan urin,
English: Women of child-bearing potential
Slovenian: Ženske v rodni dobi
English: In a clinical study in healthy volunteers, steady-state dosing with ambrisentan 10 mg once daily did not significantly affect the single-dose pharmacokinetics of the ethinyl estradiol and norethindrone components of a combined oral contraceptive (see section 5.2).
Slovenian: V kliničnih študijah pri zdravih prostovoljkah odmerjanje ambrisentana 10 mg enkrat na dan v stanju dinamičnega ravnovesja ni pomembno vplivalo na farmakokinetiko enkratnega odmerka etinilestradiolske in noretindronske sestavine kombiniranega peroralnega kontraceptiva (glejte poglavje 5.2).