FrancophonIA/ELRC3.0 huggingface dataset:
English: • Ambrisentan blocks the ETA receptor subtype, localized predominantly on vascular smooth muscle cells and cardiac myocytes.
Slovenian: • Ambrisentan blokira podtip receptorjev ETA, ki se nahajajo predvsem v gladkih mišičnih celicah žilne stene in srčnih miocitih.
English: Steady-state is generally achieved following 4 days of repeat dosing.
Slovenian: Stanje dinamičnega ravnovesja je običajno doseženo po 4 dnevnem zdravljenju.
English: Volibris tablets contain lactose.
Slovenian: Volibris tablete vsebujejo laktozo.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve za predložitev rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive
English: The usual dose of Volibris is one 5 mg tablet, once a day.
Slovenian: Običajni odmerek zdravila Volibris je ena 5 mg tableta enkrat na dan.
English: Time to First Clinical Failure Event (Adjudicated) Clinical failure, no. (%)
Slovenian: Prvi dogodek kliničnega neuspeha (presojeno) Klinični neuspeh, št. (%)
English: Talk to your doctor before taking this medicine if you have:
Slovenian: Opozorila in previdnostni ukrepi Posvetujte se z zdravnikom, preden vzamete to zdravilo, če imate:
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).
Slovenian: V skupini s kombiniranim odmerkom je bilo opaženo statistično pomembno izboljšanje (3,41 ± 6,96) na lestvici telesne zmogljivosti vprašalnika o kakovosti življenja SF-36 (SF-36 Health Survey) v primerjavi s placebom (-0,20 ± 8,14, p = 0,005).
English: • liver injury • inflammation of the liver caused by the body's own defences (autoimmune hepatitis)
Slovenian: • vnetje jeter, ki ga povzroči lastni obrambni sistem telesa (avtoimunski hepatitis).
English: If you forget to take Volibris
Slovenian: Če ste pozabili vzeti zdravilo Volibris
English: With the exception of a 13% increase in sildenafil Cmax following co-administration with ambrisentan, there were no other changes in the pharmacokinetic parameters of sildenafil, N-desmethyl-sildenafil and ambrisentan.
Slovenian: Z izjemo 13-odstotnega povečanja vrednosti Cmax sildenafila pri sočasni uporabi ambrisentana, drugih sprememb farmakokinetičnih parametrov sildenafila, N-desmetil-sildenafila in ambrisentana niso zasledili.
English: Other medicines and Volibris Tell your doctor or pharmacist if you're taking, have recently taken or might take any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo.
English: A total of 17 patients (6.5%) in the ambrisentan treatment groups had decreases in haemoglobin of ≥15% from baseline and which fell below the lower limit of normal.
Slovenian: (6,5 %) koncentracija hemoglobina od izhodišča znižala za ≥ 15 % in je bila nižja od spodnje meje normalne vrednosti.
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: V skupini, ki je prejemala ambrisentan, so zabeležili 90 dogodkov (27 %) napredovanja IPF (vključno s hospitalizacijo zaradi dihalnih razlogov) ali smrti; v skupini, ki je prejemala placebo, pa so takšnih dogodkov zabeležili 28 (17 %).
English: Ambrisentan has minor or moderate influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Ambrisentan ima majhen ali zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
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.
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: 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 živalih moškega spola so povezali s kronično uporabo ERA, vključno z ambrisentanom (glejte poglavje 5.3).
English: Upper respiratory (e.g. nasal, sinus) congestion, sinusitis, nasopharyngitis, rhinitis
Slovenian: Kongestija zgornjih dihal (to je nosne votline, sinusov), sinuzitis, nazofaringitis, rinitis
English: → It is important that you have these regular blood tests for as long as you are taking Volibris.
Slovenian: → Pomembno je, da se te krvne preiskave opravljajo redno ves čas zdravljenja z zdravilom Volibris.
English: The Cmax and AUC(0-∞) were slightly decreased for ethinyl estradiol (8% and 4%, respectively), and slightly increased for norethindrone (13% and 14 %, respectively).
Slovenian: Cmax in AUC(0-∞) etinilestradiola sta se rahlo zmanjšali (Cmax za 8 % in AUC za 4 %), noretindrona pa rahlo povečali (Cmax za 13 % in AUC za 14 %).
English: 6 Cases of worsening dyspnoea of unclear aetiology have been reported shortly after starting ambrisentan therapy.
Slovenian: 6 Opisani so bili primeri poslabšanja dispneje nejasne etiologije, ki se je pojavila kmalu po začetku zdravljenja z ambrisentanom.
English: Volibris may cause side effects, such as low blood pressure, dizziness, tiredness (see section 4), that may affect your ability to drive or use machines.
Slovenian: Zdravilo Volibris lahko povzroči neželene učinke, npr. nizek krvni tlak, omotico, utrujenost (glejte poglavje 4), ki lahko poslabšajo vašo sposobnost upravljanja vozil in strojev.
English: Hypersensitivity to the active substance, to soya, or to any of the excipients listed in section 6.1.
Slovenian: 4.3 Kontraindikacije Preobčutljivost na zdravilno učinkovino, sojo ali pomožne snovi, navedene v poglavju 6.1.
English: Volibris widens the pulmonary arteries, making it easier for the heart to pump blood through them.
Slovenian: Zdravilo Volibris širi pljučne arterije in tako srcu olajša potiskanje krvi v njih.
English: There is no experience in PAH patients of ambrisentan at daily doses greater than 10 mg.
Slovenian: Pri bolnikih s PAH ni izkušenj z uporabo ambrisentana v odmerkih, večjih od 10 mg.
English: 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).
Slovenian: Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Dodatek I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
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.
Slovenian: 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.
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, which means that it is essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na tableto, kar v bistvu pomeni »brez natrija«.
English: 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.
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 leta zdravljenja z ambrisentanom.
English: Multiple doses of ambrisentan resulted in slight increases in digoxin AUC0-last and trough concentrations, and a 29% increase in digoxin Cmax.
Slovenian: 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 %.
English: → Don't stop taking Volibris unless you have agreed this with your doctor.
Slovenian: Ne prenehajte z jemanjem zdravila Volibris, razen če vam tako svetuje vaš zdravnik.
English: In vitro studies in rat hepatocytes also showed that ambrisentan did not induce Pgp, BSEP or MRP2 protein expression.
Slovenian: Tudi študije na podganjih jetrnih celicah in vitro so pokazale, da ambrisentan ne inducira ekspresije beljakovin Pgp, BSEP ali MRP2
English: 30x1 film-coated tablets.
Slovenian: 30 x1 filmsko obložene tablete
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: 7 The incidence of nasal congestion was dose related during ambrisentan therapy.
Slovenian: 7 Pojavnost nosne kongestije je bila med zdravljenjem z ambrisentanom odvisna od odmerka.
English: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Magnesium stearate
Slovenian: Jedro tablete laktoza monohidrat mikrokristalna celuloza premreženi natrijev karmelozat magnezijev stearat
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: → If you become pregnant or think that you may be pregnant while you're taking Volibris, see your doctor immediately.
Slovenian: → Če med jemanjem zdravila Volibris zanosite ali mislite, da ste zanosili, se nemudoma posvetujte s svojim zdravnikom.
English: 3 Data derived from routine pharmacovigilance surveillance and frequencies based on placebocontrolled clinical trial experience.
Slovenian: 3 Podatki iz rednega farmakovigilančnega spremljanja in pogostnosti na podlagi izkušenj kliničnih preskušanj, kontroliranih s placebom.
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: -1,8 do -0,4; p = 0,019; skupina s kombiniranim odmerkom)).
English: Hospitalisation for worsening PAH
Slovenian: Sprejem v bolnišnico zaradi poslabšanja PAH Napredovanje bolezni
English: In the post-marketing period, cases of anaemia requiring blood cell transfusion have been reported (see section 4.4).
Slovenian: Med obdobjem trženja zdravila so bili opisani primeri anemije, ki so zahtevali transfuzijo krvnih celic (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 alanin aminotransferaze (ALT) ali obeh) >3xZMN (glejte poglavji 4.2 in 4.4).
English: Monotherapy Pooled (N=247)
Slovenian: Monoterapija kumulativno (N = 247)
English: Cardiac disorders Cardiac failure
Slovenian: Srčne bolezni Srčno popuščanje
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: 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: Volibris tablets contain less than 1 mmol sodium (23 mg), which is essentially ‘sodium-free'.
Slovenian: Tablete zdravila Volibris vsebujejo manj kot 1 mmol (23 mg) natrija, kar v bistvu pomeni »brez natrija«.
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: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT
Slovenian: D. POGOJI IN OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
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 >2x ZMN.
English: PHARMACEUTICAL FORM AND CONTENTS 10x1 film-coated tablets.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 10 x1 filmsko obložene tablete
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 (>3x ZMN); glejte poglavji 4.3 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: 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%).
Slovenian: 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 %).
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).
Slovenian: Pomožne snovi so: laktoza monohidrat, mikrokristalna celuloza, premreženi natrijev karmelozat, magnezijev stearat, polivinilalkohol, smukec (E553b), titanov dioksid (E171), makrogol 3350,
English: This leaflet was last revised in
Slovenian: Navodilo je bilo nazadnje revidirano dne:{MM/LLLL}
English: 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.
Slovenian: 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
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.
Slovenian: 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.
English: Volibris tablets contain a colouring called Allura red AC Aluminium Lake (E129) which can cause allergic reactions (see section 4).
Slovenian: Volibris tablete vsebujejo barvilo, imenovano alurno rdeče AC (E129), ki lahko povzroči alergijske reakcije (glejte poglavje 4).
English: Volibris 10 mg film-coated tablets EU/1/08/451/003
Slovenian: Volibris 10 mg filmsko obložene tablete EU/1/08/451/003
English: INFORMATION IN BRAILLE volibris 10 mg
Slovenian: PODATKI V BRAILLOVI PISAVI volibris 10 mg
English: Data derived from routine pharmacovigilance surveillance, frequencies based on statistical modelling of placebocontrolled clinical trial data.
Slovenian: Podatki iz rednega farmakovigilančnega spremljanja, pogostnosti temeljijo na statističnem modeliranju podatkov iz kliničnih preskušanj, kontroliranih s placebom.
English: 2 The frequency of headache appeared higher with 10 mg ambrisentan.
Slovenian: 2 Glavobol je bil pogostejši pri 10 mg odmerku ambrisentana.
English: Volibris is supplied as 5 mg and 10 mg film-coated tablets in unit dose blister packs of 10x1 or 30x1 tablets.
Slovenian: 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.
English: Tadalafil monotherapy (N=121)
Slovenian: Monoterapija s tadalafilom (N = 121)
English: Ambrisentan in combination with tadalafil When used in combination with tadalafil, Volibris should be titrated to 10 mg once daily.
Slovenian: Če zdravilo Volibris bolnik uporablja v kombinaciji s tadalafilom, je treba odmerek zdravila Volibris titrirati na 10 mg enkrat na dan.
English: Pack sizes with unit dose blisters of 10x1 or 30x1 film-coated tablets.
Slovenian: Velikosti pakiranj s pretisnimi omoti za enkraten odmerek z 10 x 1 ali 30 x 1 filmsko obloženo tableto.
English: 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.
Slovenian: 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
English: Volibris tablets contain lecithin derived from soya.
Slovenian: Tablete zdravila Volibris vsebujejo iz soje pridobljen lecitin.
English: Ambrisentan has not been studied in a sufficient number of patients to establish the benefit/risk balance in WHO functional class I PAH.
Slovenian: 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.
English: INFORMATION IN BRAILLE volibris 5 mg
Slovenian: PODATKI V BRAILLOVI PISAVI volibris 5 mg
English: 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).
Slovenian: 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).
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.
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: 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: EU/1/08/451/004 30 film-coated tablets
Slovenian: EU/1/08/451/004 30 filmsko obloženih tablet
English: Peel back the outer layer: starting at the coloured corner, lift and peel over the pocket.
Slovenian: Odlepite zadnjo plast: začnite na obarvanem vogalu ter jo dvignite in odlepite prek celotnega žepa.
English: This is a very common side effect that may affect more than one in 10 people
Slovenian: To je zelo pogost neželen učinek, ki se lahko pojavi pri več kot 1 od 10 bolnikov.
English: 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.
Slovenian: 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.
English: Manufacturer Aspen Bad Oldesloe GmbH Industriestrasse 32-36 D-23843 Bad Oldesloe Germany
Slovenian: Aspen Bad Oldesloe GmbH Industriestrasse 32-36
English: Secondary endpoints Secondary endpoints were tested:
Slovenian: Sekundarni opazovani dogodki Testirani so bili sekundarni opazovani dogodki: Preglednica 2
English: Taking out a tablet
Slovenian: Kako vzamete tableto iz pakiranja
English: 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).
Slovenian: 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).
English: PVC/PVDC/aluminium foil blisters.
Slovenian: Pretisni omoti iz PVC/PVDC/aluminijske folije.
English: 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.
Slovenian: ambrisentana (121 % po prvem in 116 % po drugem odmerku rifampicina), verjetno zaradi zavrtja
English: 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.
Slovenian: 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.
English: (ARIES-C and post marketing)
Slovenian: Ambrisentan (ARIES-C in po prihodu zdravila na trg)
English: What Volibris looks like and contents of the pack
Slovenian: Izgled zdravila Volibris in vsebina pakiranja