natgillin/translations-raw huggingface dataset:
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). 
Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Dodatek I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
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. 
V 12-tedenskih s placebom kontroliranih kliničnih preskušanjih je bilo povprečno znižanje sistoličnega krvnega tlaka od izhodišča do konca zdravljenja 3 mmHg in diastoličnega krvnega tlaka 4,2 mmHg.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, which means that it is essentially ‘sodium-free'. 
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na tableto, kar v bistvu pomeni »brez natrija«.
Mean decreases from baseline (ranging from 0.9 to 1.2 g/dL) in hemoglobin 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. 
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 leta zdravljenja z ambrisentanom.
Multiple doses of ambrisentan resulted in slight increases in digoxin AUC0-last and trough concentrations, and a 29% increase in digoxin Cmax. 
Pri ponavljajočih se odmerkih ambrisentana so ugotovili rahlo zvišanje vrednosti AUC0-last digoksina in najmanjših koncentracij digoksina v stanju dinamičnega ravnovesja, ter zvišanje vrednosti Cmax digoksina za 29 %.
→ Don't stop taking Volibris unless you have agreed this with your doctor. 
Ne prenehajte z jemanjem zdravila Volibris, razen če vam tako svetuje vaš zdravnik.
In vitro studies in rat hepatocytes also showed that ambrisentan did not induce Pgp, BSEP or MRP2 protein expression. 
Tudi študije na podganjih jetrnih celicah in vitro so pokazale, da ambrisentan ne inducira ekspresije beljakovin Pgp, BSEP ali MRP2
30x1 film-coated tablets. 
30 x1 filmsko obložene tablete
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. 
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.
7 The incidence of nasal congestion was dose related during ambrisentan therapy. 
7 Pojavnost nosne kongestije je bila med zdravljenjem z ambrisentanom odvisna od odmerka.
Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Magnesium stearate 
Jedro tablete laktoza monohidrat mikrokristalna celuloza premreženi natrijev karmelozat magnezijev stearat
• 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. 
• 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.
→ If you become pregnant or think that you may be pregnant while you're taking Volibris, see your doctor immediately. 
→ Če med jemanjem zdravila Volibris zanosite ali mislite, da ste zanosili, se nemudoma posvetujte s svojim zdravnikom.
3 Data derived from routine pharmacovigilance surveillance and frequencies based on placebocontrolled clinical trial experience. 
3 Podatki iz rednega farmakovigilančnega spremljanja in pogostnosti na podlagi izkušenj kliničnih preskušanj, kontroliranih s placebom.
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)). 
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: -1,8 do -0,4; p = 0,019; skupina s kombiniranim odmerkom)).
Hospitalisation for worsening PAH 
Sprejem v bolnišnico zaradi poslabšanja PAH Napredovanje bolezni
In the post-marketing period, cases of anaemia requiring blood cell transfusion have been reported (see section 4.4). 
Med obdobjem trženja zdravila so bili opisani primeri anemije, ki so zahtevali transfuzijo krvnih celic (glejte poglavje 4.4).
Baseline values of hepatic aminotransferases (aspartate aminotransferases (AST) and/or alanine aminotransferases (ALT))>3xULN (see sections 4.2 and 4.4). 
Izhodiščne vrednosti jetrnih aminotransferaz (aspartat-aminotransferaze (AST) ali alanin aminotransferaze (ALT) ali obeh) >3xZMN (glejte poglavji 4.2 in 4.4).
Monotherapy Pooled (N=247) 
Monoterapija kumulativno (N = 247)
Cardiac disorders Cardiac failure 
Srčne bolezni Srčno popuščanje
In vitro, ambrisentan has no inhibitory effect on human transporters at clinically relevant concentrations, including Pgp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3 and NTCP. 
In vitro ambrisentan v klinično pomembnih koncentracijah ne zavira humanih prenašalcev, vključno s Pgp, BRCP, MRP2, BSEP, OATP1B1, OATP1B3 in NTCP.
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. 
Povprečno znižanje sistoličnega in diastoličnega krvnega tlaka se je v dolgotrajni odprti študiji ARIES E ohranilo do 4 leta zdravljenja z ambrisentanom.
Volibris tablets contain less than 1 mmol sodium (23 mg), which is essentially ‘sodium-free'. 
Tablete zdravila Volibris vsebujejo manj kot 1 mmol (23 mg) natrija, kar v bistvu pomeni »brez natrija«.
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. 
Pri bolnikih z zmerno okvaro ledvic je obseg zmanjšanja očistka pri peroralni uporabi zmeren (20-40 %) in tako je klinični pomen malo verjeten.
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT 
D. POGOJI IN OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
Patients with ALT and AST values >2xULN at baseline were also excluded. 
Prav tako niso bili vključeni bolniki z izhodiščnimi vrednostmi ALT oz. AST >2x ZMN.
PHARMACEUTICAL FORM AND CONTENTS 10x1 film-coated tablets. 
FARMACEVTSKA OBLIKA IN VSEBINA 10 x1 filmsko obložene tablete
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). 
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 (>3x ZMN); glejte poglavji 4.3 in 4.4).
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. 
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.
In ARIES-2, ambrisentan (combined dose group) significantly delayed the time to clinical worsening of PAH compared to placebo (p<0.001), the hazard ratio demonstrated an 80% reduction (95% CI: 47% to 92%). 
V študiji ARIES-2 je ambrisentan (skupina s kombiniranim odmerkom) v primerjavi s placebom pomembno podaljšal čas do kliničnega poslabšanja PAH (p < 0,001), razmerje tveganja kaže 80 % zmanjšanje (95 % interval zaupanja: 47 % do 92 %).
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). 
Pomožne snovi so: laktoza monohidrat, mikrokristalna celuloza, premreženi natrijev karmelozat, magnezijev stearat, polivinilalkohol, smukec (E553b), titanov dioksid (E171), makrogol 3350,
This leaflet was last revised in 
Navodilo je bilo nazadnje revidirano dne:{MM/LLLL}
There is limited experience with ambrisentan in individuals with severe renal impairment (creatinine clearance <30 ml/min); therapy should be initiated cautiously in this subgroup and particular care taken if the dose is increased to 10 mg ambrisentan. 
Pri bolnikih s hudo okvaro ledvic (kreatininski očistek < 30 ml/min) so izkušnje z uporabo ambrisentana omejene.Pri tej podskupini bolnikov je treba zdravljenje uvesti previdno, pri povečanju odmerka ambrisentana na
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. 
Pri ženskah v rodni dobi se zdravljenje z zdravilom Volibris ne sme uvesti, če test za ugotavljanje nosečnosti, izveden pred začetkom zdravljenja, ni negativen, in ženska ne uporablja zanesljive metode kontracepcije.
Volibris tablets contain a colouring called Allura red AC Aluminium Lake (E129) which can cause allergic reactions (see section 4). 
Volibris tablete vsebujejo barvilo, imenovano alurno rdeče AC (E129), ki lahko povzroči alergijske reakcije (glejte poglavje 4).
Volibris 10 mg film-coated tablets EU/1/08/451/003 
Volibris 10 mg filmsko obložene tablete EU/1/08/451/003
INFORMATION IN BRAILLE volibris 10 mg 
PODATKI V BRAILLOVI PISAVI volibris 10 mg
Data derived from routine pharmacovigilance surveillance, frequencies based on statistical modelling of placebocontrolled clinical trial data. 
Podatki iz rednega farmakovigilančnega spremljanja, pogostnosti temeljijo na statističnem modeliranju podatkov iz kliničnih preskušanj, kontroliranih s placebom.
2 The frequency of headache appeared higher with 10 mg ambrisentan. 
2 Glavobol je bil pogostejši pri 10 mg odmerku ambrisentana.
Volibris is supplied as 5 mg and 10 mg film-coated tablets in unit dose blister packs of 10x1 or 30x1 tablets. 
Zdravilo Volibris je na voljo v obliki 5 mg in 10 mg filmsko obloženih tablet v pretisnih omotih za enkratni odmerek v pakiranjih po 10 x 1 ali 30 x 1 tableto.
Tadalafil monotherapy (N=121) 
Monoterapija s tadalafilom (N = 121)
Ambrisentan in combination with tadalafil When used in combination with tadalafil, Volibris should be titrated to 10 mg once daily. 
Če zdravilo Volibris bolnik uporablja v kombinaciji s tadalafilom, je treba odmerek zdravila Volibris titrirati na 10 mg enkrat na dan.
Pack sizes with unit dose blisters of 10x1 or 30x1 film-coated tablets. 
Velikosti pakiranj s pretisnimi omoti za enkraten odmerek z 10 x 1 ali 30 x 1 filmsko obloženo tableto.
Patients with pre-existent hepatic disease (cirrhosis or clinically significantly elevated aminotransferases) and patients using other targeted therapy for PAH (e.g. prostanoids) were excluded. 
Bolniki, ki so že imeli bolezen jeter (ciroza ali klinično pomembno zvišanje aktivnosti aminotransferaz) in bolniki, ki so se zdravili z drugo obliko usmerjenega zdravljenja PAH
Volibris tablets contain lecithin derived from soya. 
Tablete zdravila Volibris vsebujejo iz soje pridobljen lecitin.
Ambrisentan has not been studied in a sufficient number of patients to establish the benefit/risk balance in WHO functional class I PAH. 
4.4 Posebna opozorila in previdnostni ukrepi Ambrisentan ni bil raziskan pri zadostnem številu bolnikov, da bi lahko ugotovili razmerje med koristjo in tveganjem pri PAH funkcijskega razreda I po SZO.
INFORMATION IN BRAILLE volibris 5 mg 
PODATKI V BRAILLOVI PISAVI volibris 5 mg
Each tablet contains approximately 95 mg of lactose (as monohydrate), approximately 0.25 mg of lecithin (soya) (E322) and approximately 0.11 mg of Allura red AC Aluminium Lake (E129). 
Ena tableta vsebuje približno 95 mg laktoze (v obliki monohidrata), približno 0,25 mg lecitina (soja) (E322) in približno 0,11 mg barvila alurno rdeče AC (E129).
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. 
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.
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.
EU/1/08/451/004 30 film-coated tablets 
EU/1/08/451/004 30 filmsko obloženih tablet
Peel back the outer layer: starting at the coloured corner, lift and peel over the pocket. 
Odlepite zadnjo plast: začnite na obarvanem vogalu ter jo dvignite in odlepite prek celotnega žepa.
This is a very common side effect that may affect more than one in 10 people 
To je zelo pogost neželen učinek, ki se lahko pojavi pri več kot 1 od 10 bolnikov.
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.
Secondary endpoints Secondary endpoints were tested: 
Sekundarni opazovani dogodki Testirani so bili sekundarni opazovani dogodki: Preglednica 2
Taking out a tablet 
Kako vzamete tableto iz pakiranja
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).
PVC/PVDC/aluminium foil blisters. 
Pretisni omoti iz PVC/PVDC/aluminijske folije.
Following initial doses of rifampicin, a transient increase in ambrisentan AUC(0-τ) (121% and 116% after first and second doses of rifampicin, respectively) was observed, presumably due to a rifampicin-mediated OATP inhibition. 
ambrisentana (121 % po prvem in 116 % po drugem odmerku rifampicina), verjetno zaradi zavrtja
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, bi okvara jeter morda lahko povečala izpostavljenost (Cmax in AUC) ambrisentanu.
(ARIES-C and post marketing) 
Ambrisentan (ARIES-C in po prihodu zdravila na trg)
What Volibris looks like and contents of the pack 
Izgled zdravila Volibris in vsebina pakiranja
Time to First Hospitalisation for Worsening PAH (Adjudicated) First hospitalisation, no. 
Čas od prvega sprejema v bolnišnico zaradi poslabšanja PAH (presojeno)
That women of reproductive potential must use effective contraception; The need for monthly pregnancy tests; 
− da je potrebno mesečno izvajanje testov nosečnosti;
Volibris tablets contain the azo colouring agent Allura red AC Aluminium Lake (E129), which can cause allergic reactions. 
Volibris tablete vsebujejo azo barvilo alurno rdeče AC (E129), ki lahko povzroči alergijske reakcije.
Deep-pink, oval, convex, film-coated tablet with “GS” debossed on one side and “KE3” on the other side. 
Temnorožnate, ovalne, konveksne, filmsko obložene tablete z oznako "GS" na eni in "KE3" na drugi strani.
Vascular disorders Hypotension 
Žilne bolezni Hipotenzija
Immune system disorders Hypersensitivity reactions (e.g. angioedema, rash, pruritus) 
Preobčutljivostne reakcije (npr. angioedem, izpuščaj in pruritus)
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.
Idiopathic pulmonary fibrosis (IPF), with or without secondary pulmonary hypertension (see section 
Idiopatska pljučna fibroza (IPF) s sekundarno pljučno hipertenzijo ali brez nje (glejte poglavje 5.1).
This slight increase in sildenafil Cmax is not considered clinically relevant (see section 
To rahlo povečanje vrednosti Cmax sildenafila ni klinično pomembno (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.
Respiratory, thoracic and mediastinal disorders Epistaxis 
Bolezni dihal, prsnega koša in mediastinalnega prostora Epistaksa
Contains lactose, lecithin (soya) (E322) and Allura red AC Aluminium Lake (E129). 
Vsebuje laktozo, lecitin (soja) (E322) in alurno rdeče AC (E129).
How to take Volibris 
Kako jemati zdravilo Volibris
Each film-coated tablet contains 5 or 10 mg. 
Ena filmsko obložena tableta vsebuje 5 ali 10 mg ambrisentana.
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). 
Peroralni kontraceptivi 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).
See leaflet for further information 
Za dodatne informacije glejte priloženo navodilo.
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. 
poročali o neželenih učinkih na vedenje mater, zmanjšanem preživetju mladičev in manjši sposobnosti za razmnoževanje mladičev (pri nekropsiji so poročali o majhnih testisih).
8 Cases of autoimmune hepatitis, including cases of exacerbation of autoimmune hepatitis, and hepatic injury have been reported during ambrisentan therapy. 
8 Med zdravljenjem z ambrisentanom so bili opisani primeri avtoimunskega hepatitisa, vključno s primeri poslabšanja avtoimunskega hepatitisa, in okvara jeter.
Aspen Bad Oldesloe GmbH Industriestrasse 32-36 D-23843 Bad Oldesloe Germany or 
Industriestrasse 32-36 D-23843 Bad Oldesloe
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 (> 3x ZMN) (glejte poglavji 4.3 in 4.4).
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 <
Hepatic transaminases increased Common3 
Zvišanje jetrnih transaminaz
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. 
Pri bolnikih, ki so prejemali ambrisentan, se je med 12-tedenskimi s placebom nadzorovanimi kliničnimi študijami 3. faze srednja vrednost koncentracije hemoglobina znižala, kar so ugotovili že 4. teden (znižanje za 0,83 g/dl).
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%). 
UGT1A6, UGT1A9, UGT2B7 (do 30 %) ali encimov citokroma P450 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 in 3A4 (do 25 %).
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. 
5.3 Predklinični podatki o varnosti 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 pojavi hipotenzija ter simptomi s tem povezane vazodilatacije.
Contents of the pack and other information 
Shranjevanje zdravila Volibris Vsebina pakiranja in dodatne informacije
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).
Pale-pink, square, convex, film-coated tablet with “GS” debossed on one side and “K2C” on the other side. 
Svetlorožnate, kvadratne, konveksne filmsko obložene tablete z oznako "GS" na eni in "K2C" na drugi strani.
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 ter in vivo predkliničnih študijah ambrisentan pri klinično pomembnih koncentracijah ni zaviral ali induciral encimov, ki presnavljajo zdravila v I. in II.
→ If it is possible you could become pregnant, use a reliable form of birth control (contraception) while you're taking Volibris. 
→ Če obstaja možnost zanositve, morate med zdravljenjem z zdravilom Volibris uporabljati zanesljivo obliko kontracepcije.
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 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 in genotoksičnega delovanja ambrisentana niso ugotovili.
• Obligation to conduct post-authorisation measures 
• Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet Navedba smiselno ni potrebna.