natgillin/translations-raw huggingface dataset:
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.
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.
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.
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.
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.
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.
It is not known whether ambrisentan is excreted in human breast milk.
Ni znano, če se ambrisentan izloča v materino mleko.
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).
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).
Data derived from routine pharmacovigilance surveillance, frequencies based on statistical modelling of placebo controlled clinical trial data.
Podatki iz rednega farmakovigilančnega spremljanja, pogostnosti temeljijo na statističnem modeliranju podatkov iz kliničnih preskušanj, kontroliranih s placebom.
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.
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).
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).
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).
Ambrisentan Mylan contains the active substance ambrisentan.
Zdravilo Ambrisentan Mylan vsebuje učinkovino ambrisentan.
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).
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).
• itching of your skin.
• srbenje kože.
It is not known if Ambrisentan Mylan is transferred to breast milk.
Ni znano, če se zdravilo Ambrisentan Mylan izloča v materino mleko.
Warfarin also had no clinically significant effects on the pharmacokinetics of ambrisentan.
Tudi varfarin ni imel klinično pomembnih učinkov na farmakokinetiko ambrisentana.
In combination with tadalafil
V kombinaciji s tadalafilom
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.
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.
Patients with significant anaemia, fluid retention or rare retinal diseases were excluded according to the investigators' criteria.
Po preiskovalčevih merilih niso bili vključeni bolniki s pomembno anemijo, zastajanjem tekočine ali redkimi boleznimi mrežnice.
Monthly pregnancy tests during treatment with ambrisentan are recommended (see sections 4.3 and 4.6).
Med zdravljenjem z ambrisentanom priporočamo mesečno izvajanje testov za ugotavljanje nosečnosti (glejte poglavji 4.3 in 4.6).
The frequency of decreased haemoglobin (anaemia) was higher with 10 mg ambrisentan.
Znižana koncentracija hemoglobina (anemija) je bila pogostejša pri uporabi 10 mg odmerka ambrisentana.
After oral administration, maximum plasma concentrations (Cmax) of ambrisentan typically occur around 1.5 hours post-dose under both fasted and fed conditions.
Največje plazemske koncentracije (Cmax) ambrisentana se tipično pojavijo približno 1,5 ure po peroralnem odmerku, tako pri jemanju zdravila na tešče kot po obroku.
• a runny nose
• izcedek iz nosu,
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.
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.
This is a common side effect that may affect up to one in 10 people.
To je pogost neželen učinek, ki se lahko pojavi pri največ 1 od 10 bolnikov.
However, by day 8, steady state administration of rifampicin had no clinically relevant effect on ambrisentan exposure.
Toda po 8 dneh uporaba rifampicina v stanju dinamičnega ravnovesja ni klinično pomembno vplivala na izpostavljenost ambrisentanu.
Anaemia (reduced number of red blood cells)
Anemija (zmanjšanje števila krvnih celic)
• chest pain or discomfort
• bolečine ali nelagodje v prsih,
Ambrisentan in combination with tadalafil
Ambrisentan v kombinaciji s tadalafilom
• dark-coloured urine
• temno obarvan urin,
Women of child-bearing potential
Ženske v rodni dobi
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).
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).
When used in combination with tadalafil, Ambrisentan Mylan should be titrated to 10 mg once daily.
Če zdravilo Ambrisentan Mylan bolnik uporablja v kombinaciji s tadalafilom, je treba odmerek zdravila Ambrisentan Mylan titrirati na 10 mg enkrat na dan.
Since the main routes of metabolism of ambrisentan are glucuronidation and oxidation with subsequent elimination in the bile, hepatic impairment might be expected to increase exposure (Cmax and AUC) to ambrisentan.
Ker glavna presnovna pot ambrisentana poteka preko glukuronidacije in oksidacije ter kasnejšega izločanja z žolčem, lahko pričakujemo, da se bi pri okvari jeter morda lahko povečala izpostavljenost (Cmax in AUC) ambrisentanu.
The primary analysis was combination group vs. pooled monotherapy groups.
Primarna analiza je primerjala skupino s kombiniranim zdravljenjem s kumulativnima skupinam z monoterapijo.
There was a small increase in mammary fibroadenomas, a benign tumor, in male rats at the highest dose only.
Samo pri najvišjem odmerku so pri podganjih samcih ugotovili majhno povečanje mamarnih fibroadenomov, ki so benigni tumorji.
Steady-state co-administration of ambrisentan and cyclosporine A resulted in a 2-fold increase in ambrisentan exposure in healthy volunteers.
Sočasna uporaba ambrisentana in ciklosporina A v stanju dinamičnega ravnovesja je pri zdravih prostovoljcih povzročila 2-kratno povečanje izpostavljenosti ambrisentanu.
Supportive comparisons of combination therapy group vs. the individual monotherapy groups were also made.
Narejene so bile tudi podporne primerjave skupine s kombiniranim zdravljenjem v primerjavi z vsako posamezno skupino z monoterapijo.
Taken together, the in vitro data suggest ambrisentan at clinically relevant concentrations (plasma Cmax up to 3.2 μM) would not be expected to have an effect on UGT1A1, UGT1A6, UGT1A9, UGT2B7 or cytochrome P450 enzymes 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4 or transport via BSEP, BCRP, Pgp, MRP2, OATP1B1/3, or NTCP.
Vsi in vitro podatki skupaj kažejo, da pri klinično pomembnih koncentracijah ambrisentana (Cmax v plazmi do 3,2 µM) ni pričakovati vpliva na UGT1A1, UGT1A6, UGT1A9, UGT2B7 ali encime citokroma P450 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4 ali na transport z BSEP, BCRP, Pgp, MRP2, OATP1B1/3 ali NTCP.
Similarly, co-administration with tadalafil did not affect the pharmacokinetics of ambrisentan (see section 4.5).
Podobno tudi sočasna uporaba tadalafila ne vpliva na farmakokinetiko ambrisentana (glejte poglavje 4.5).
Ambrisentan was clastogenic when tested at high concentrations in mammalian cells in vitro.
Ambrisentan je in vitro na sesalskih celicah v visokih koncentracijah deloval klastogeno.
The efficacy and safety of ambrisentan when co-administered with other treatments for PAH (e.g. prostanoids and soluble guanylate cyclase stimulators) has not been specifically studied in controlled clinical trials in PAH patients (see section 5.1).
V nadzorovanih kliničnih preskušanjih pri bolnikih s PAH učinkovitosti in varnosti ambrisentana pri sočasni uporabi z drugimi zdravili za zdravljenje PAH (npr. prostanoidi in spodbujevalci topne gvanilat-ciklaze) niso posebej proučevali (glejte poglavje 5.1).
However, caution should be used in patients with severe renal impairment (see section 4.2).
Pri bolnikih s hudo okvaro ledvic je kljub temu potrebna previdnost (glejte poglavje 4.2).
There was no evidence of carcinogenic potential in 2 year oral studies in rats and mice.
Pri 2-letnih študijah peroralne uporabe pri podganah in miših niso ugotovili znakov kancerogenega potenciala.
The frequency of headache appeared higher with 10 mg ambrisentan.
Glavobol je bil pogostejši pri 10 mg odmerku ambrisentana.
The effects of repeat dosing of ambrisentan (10 mg) on the pharmacokinetics of single dose digoxin were studied in 15 healthy volunteers.
Učinek ponavljajočega se odmerka ambrisentana (10 mg) na farmakokinetiko enkratnega odmerka digoksina so raziskovali pri 15 zdravih prostovoljcih.
Steady-state administration of ambrisentan in healthy volunteers had no clinically relevant effects on the single-dose pharmacokinetics of digoxin, a substrate for Pgp (see section 5.2).
Pri zdravih prostovoljcih pri uporabi ambrisentana v stanju dinamičnega ravnovesja niso opazili klinično pomembnih učinkov na farmakokinetiko enkratnega odmerka digoksina, substrata za Pgp (glejte poglavje 5.2).
For dose-related adverse reactions the frequency category reflects the higher dose of ambrisentan.
Pri od odmerka odvisnih neželenih učinkih je pri kategoriji pogostnosti upoštevan višji odmerek ambrisentana.
The distribution of ambrisentan into red blood cells is low, with a mean blood: plasma ratio of 0.57 and 0.61 in males and females, respectively.
Srednje razmerje kri: plazma je pri moških 0,57, pri ženskah pa 0,61.
Therapy that is recommended at the severe stage of the disease (e.g. epoprostenol) should be considered if the clinical condition deteriorates.
Če se klinično stanje poslabša, je treba razmisliti o obliki zdravljenja, ki je priporočljiva za hud stadij bolezni (npr. epoprostenol).
The placeboadjusted mean improvement in 6MWD was 44.6 m (95% CI: 24.3 to 64.9; p<0.001) for the 5 mg dose, and 52.5 m (95% CI: 28.8 to 76.2; p<0.001) for the 10 mg dose.
Za 5 mg odmerek je bilo na placebo prilagojeno izboljšanje rezultata 6MWD 44,6 m (95 % interval zaupanja: 24,3 do 64,9; p < 0,001), za 10 mg odmerek pa 52,5 m (95-% interval zaupanja: 28,8 do 76,2; p < 0,001).
In dogs, slight inflammatory responses were observed following chronic high dose administration of ambrisentan at exposures greater than 20-fold that observed in patients.
Pri psih so pri dolgotrajni uporabi visokih odmerkov ambrisentana pri izpostavljenosti, ki je bila več kot 20-krat večja od izpostavljenosti bolnika, poročali o blagih vnetnih spremembah.
Ambrisentan Mylan 10 mg film-coated tablet (tablet) is a pink, capsule shaped tablet engraved with ‘M' on one side of the tablet and ‘AN1' on the other side.
Ambrisentan Mylan 10 mg filmsko obložena tableta (tableta) je rožnata tableta v obliki kapsule, ki ima oznako „M“ na eni strani in „AN1“ na drugi strani.
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).
Potekala je študija 492 bolnikov z idiopatsko pljučno fibrozo (IPF), od katerih jih je 11 % imelo sekundarno pljučno hipertenzijo (skupina 3 po Svetovni zdravstveni organizaciji); ambrisentan jih je prejemalo 329 in placebo 163.
Therefore, ambrisentan should not be initiated in patients with severe hepatic impairment or clinically significant elevated hepatic aminotransferases (>3xULN) (see sections 4.3 and 4.4).
Zdravljenje z ambrisentanom se tako ne sme uvesti pri bolnikih s hudo okvaro jeter ali s klinično pomembnim zvišanjem vrednosti jetrnih aminotransferaz (> 3 × ZMN) (glejte poglavji 4.3 in 4.4).
Ambrisentan and its metabolites are eliminated primarily in the bile following hepatic and/or extrahepatic metabolism.
Ambrisentan in njegovi presnovki se po jetrni in/ali izvenjetrni presnovi v glavnem izločijo z žolčem.
Hypersensitivity reactions (e.g. angioedema, rash, pruritus)
Bolezni imunskega sistema preobčutljivostne reakcije (npr. angioedem, izpuščaj in pruritus)
→ If it is possible you could become pregnant, use a reliable form of birth control (contraception) while you're taking Ambrisentan Mylan.
→ Če obstaja možnost zanositve, morate med zdravljenjem z zdravilom Ambrisentan Mylan uporabljati zanesljivo obliko kontracepcije.
Ambrisentan is contraindicated in pregnancy (see section 4.3).
Med nosečnostjo je uporaba ambrisentana kontraindicirana (glejte poglavje 4.3).
No dose adjustment is required in patients with renal impairment (see section 5.2).
Pri bolnikih z okvaro ledvic odmerka ni treba prilagajati (glejte poglavje 5.2).
Exposures of ambrisentan as measured by AUC(0-inf) and Cmax were increased by 35% and 20%, respectively.
Ti vrednosti sta se povečali, in sicer AUC(0-inf) za 35 %, Cmax pa za 20 %.
This may be due to the inhibition by cyclosporine A of transporters and metabolic enzymes involved in the pharmacokinetics of ambrisentan.
To je lahko posledica inhibicije transporterjev in presnovnih encimov, vpletenih v farmakokinetiko ambrisentana, s ciklosporinom A. Zato je treba odmerek ambrisentana med sočasno uporabo s ciklosporinom A
The incidence of anaemia was increased when ambrisentan was dosed in combination with tadalafil (15% adverse event frequency), compared to the incidence of anaemia when ambrisentan and tadalafil were given as monotherapy (7% and 11%, respectively).
Pojavnost anemije je bila med uporabo ambrisentana v kombinaciji s tadalafilom večja (15 %) kot med monoterapijo z ambrisentanom (7 %) ali monoterapijo s tadalafilom (11 %).
Ambrisentan did not have any clinically relevant effects on the pharmacokinetics or pharmacodynamics of warfarin.
Ambrisentan ni imel nobenih klinično pomembnih učinkov na farmakokinetiko ali farmakodinamiko varfarina.
No evidence for mutagenic or genotoxic effects of ambrisentan were seen in bacteria or in two in vivo rodent studies.
Pri bakterijah in v dveh in vivo študijah na glodavcih mutagenega ali genotoksičnega delovanja ambrisentana niso ugotovili.
Phosphodiesterase inhibitors
Zaviralci fosfodiesteraz
The effects of repeat dosing of ketoconazole (400 mg once daily) on the pharmacokinetics of a single dose of 10 mg ambrisentan were investigated in 16 healthy volunteers.
Učinek ponavljajočega se odmerka ketokonazola (400 mg enkrat na dan) na farmakokinetiko enkratnega 10 mg odmerka ambrisentana so raziskovali pri 16 zdravih prostovoljcih.
Similarly, co-administration with warfarin did not affect the pharmacokinetics of ambrisentan (see section 4.5).
Pri sočasni uporabi tudi varfarin ni vplival na farmakokinetiko ambrisentana (glejte poglavje 4.5).
Cases consistent with autoimmune hepatitis, including possible exacerbation of underlying autoimmune hepatitis, hepatic injury and hepatic enzyme elevations potentially related to therapy have been observed with ambrisentan (see sections 4.8 and 5.1).
Med uporabo ambrisentana so opazili primere, ki se ujemajo z avtoimunskim hepatitisom, vključno z možnimi poslabšanji že obstoječega avtoimunskega hepatitisa, okvaro jeter in zvišanje vrednosti jetrnih encimov, kar bi lahko bilo povezano z zdravljenjem(glejte poglavji 4.8 in 5.1).
The potential for ambrisentan to induce CYP3A4 activity was explored in healthy volunteers with results suggesting a lack of inductive effect of ambrisentan on the CYP3A4 isoenzyme.
Potencial ambrisentana za indukcijo aktivnosti CYP3A4 so raziskovali pri zdravih prostovoljcih.
47% to 92%).
2 leti 79,7 %
Skin and subcutaneous tissue disorders Rash
Bolezni kože in podkožja izpuščaj
Time to First Clinical Failure Event (Adjudicated) Clinical failure, no. (%)
Prvi dogodek kliničnega neuspeha (presojeno) Klinični neuspeh, št. (%) 46 (18 %)
The placebo-adjusted improvement in mean 6MWD at week 12 in patients in the 10 mg group in ARIES-1 was 51.4 m (95% CI: 26.6 to 76.2; p<0.001).
V študiji ARIES-1 je pri bolnikih v skupini, ki so prejemali 10 mg odmerek, na placebo prilagojeno izboljšanje povprečnega rezultata 6MWD v 12. tednu znašalo 51,4 m (95-% interval zaupanja: 26,6 do 76,2; p < 0,001).
Ambrisentan Mylan 5 mg film-coated tablet (tablet) is a pink round biconvex tablet engraved with ‘M' on one side and ‘AN' on the other side.
Ambrisentan Mylan 5 mg filmsko obložena tableta (tableta) je rožnata, okrogla, na obeh straneh izbočena tableta z oznako „M“ na eni strani in „AN“ na drugi strani.
In the rat, hyperplasia of nasal turbinate bone is a recognised response to nasal inflammation, based on experience with other compounds.
Pri podganah je, na osnovi izkušenj z drugimi učinkovinami, hiperplazija nosnih školjk prepoznan odziv na vnetje nosne sluznice.
Ambrisentan Mylan 5 mg film-coated tablets contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'
Ambrisentan Mylan 5 mg filmsko obložene tablete vsebujejo manj kot 1 mmol (23 mg) natrija na tableto, kar v bistvu pomeni ‘brez natrija'.
The clinical status of the patient and the adverse reaction profile of ambrisentan (such as hypotension, dizziness, asthenia, fatigue) should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills (see section 4.8).
Pri ocenjevanju bolnikove zmožnosti za izvajanje opravil, ki zahtevajo presojo in motorične ali kognitivne sposobnosti, je treba upoštevati njegovo klinično stanje in profil neželenih učinkov ambrisentana (npr. hipotenzijo, omotico, astenijo in utrujenost) (glejte poglavje 4.8).
Testicular tubular atrophy, which was occasionally associated with aspermia, was observed in oral repeat dose toxicity and fertility studies with male rats and mice without safety margin.
Pri študijah toksičnosti in vplivov na plodnost so pri samcih podgan in miši pri ponavljajočih se peroralnih odmerkih brez varnostne meje poročali o atrofiji testikularnih tubulov, ki je bila občasno povezana z aspermijo.
• chest pain/discomfort.
• bolečina ali nelagodje v prsih.
The incidence of peripheral oedema was increased when ambrisentan was dosed in combination with tadalafil (45% adverse event frequency), compared to the incidence of peripheral oedema when ambrisentan and tadalafil were given as monotherapy (38% and 28%, respectively).
Pojavnost perifernih edemov je bila med uporabo ambrisentana v kombinaciji s tadalafilom večja (45 %) kot med monoterapijo z ambrisentanom (38 %) ali monoterapijo s tadalafilom (28 %).
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.
V in vitro in in vivo predkliničnih študijah ambrisentan pri klinično pomembnih koncentracijah ni zaviral ali induciral encimov, ki presnavljajo zdravila v I. in II.
Multiple doses of ambrisentan had no effect on cyclosporine A exposure, and no dose adjustment of cyclosporine A is warranted.
Večkratni odmerki ambrisentana ne vplivajo na izpostavljenost ciklosporinu A, zato odmerka ciklosporina A ni treba prilagoditi.
No specific drug-drug interactions with soluble guanylate cyclase stimulators or prostanoids are anticipated based on the known biotransformation data (see section 5.2).
Na podlagi znanih podatkov o biotransformaciji ni pričakovati specifičnih medsebojnih delovanj s spodbujevalci topne gvanilatciklaze ali prostanoidi (glejte poglavje 5.2).
Ireland or
Irska ali
Ambrisentan Mylan tablets contains lactose and Allura red (E129)
Tablete Ambrisentan Mylan vsebujejo laktozo in alurno rdeče barvilo (E129).
Cases of pulmonary oedema have been reported with vasodilating medicinal products, such as ERAs, when used in patients with pulmonary veno-occlusive disease.
Med uporabo vazodilatacijskih zdravil, kakršna so ERA, so bili pri bolnikih s pljučno venookluzivno boleznijo opisani primeri pljučnega edema.
Pink, capsule shaped, biconvex film-coated tablet with ‘M' debossed on one side and ‘AN1' on the other, approximately 9.9 mm long and 4.8 mm wide.
Rožnate, bikonveksne filmsko obložene tablete v obliki kapsule, velikosti približno 9,9 mm × 4,8 mm, z vtisnjeno oznako „M“ na eni strani in „AN1“ na drugi strani.
Therefore breast-feeding is contraindicated in patients taking ambrisentan (see section 4.3).
Zato je pri bolnicah, ki jemljejo ambrisentan, dojenje kontraindicirano (glejte poglavje 4.3).
The pharmacokinetics of ambrisentan in patients with hepatic impairment (with or without cirrhosis) has not been studied.
Pri bolnikih z okvaro jeter (s cirozo ali brez) farmakokinetike ambrisentana niso raziskovali.