FrancophonIA/ELRC3.0 huggingface dataset:
English: Time to First Hospitalisation for Worsening PAH (Adjudicated) First hospitalisation, no.
Slovenian: Čas od prvega sprejema v bolnišnico zaradi poslabšanja PAH (presojeno)
English: That women of reproductive potential must use effective contraception; The need for monthly pregnancy tests;
Slovenian: − da je potrebno mesečno izvajanje testov nosečnosti;
English: Volibris tablets contain the azo colouring agent Allura red AC Aluminium Lake (E129), which can cause allergic reactions.
Slovenian: Volibris tablete vsebujejo azo barvilo alurno rdeče AC (E129), ki lahko povzroči alergijske reakcije.
English: Deep-pink, oval, convex, film-coated tablet with “GS” debossed on one side and “KE3” on the other side.
Slovenian: Temnorožnate, ovalne, konveksne, filmsko obložene tablete z oznako "GS" na eni in "KE3" na drugi strani.
English: Vascular disorders Hypotension
Slovenian: Žilne bolezni Hipotenzija
English: Immune system disorders Hypersensitivity reactions (e.g. angioedema, rash, pruritus)
Slovenian: Preobčutljivostne reakcije (npr. angioedem, izpuščaj in pruritus)
English: 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.
Slovenian: Srednje razmerje kri:plazma je pri moških 0,57, pri ženskah pa 0,61.
English: Idiopathic pulmonary fibrosis (IPF), with or without secondary pulmonary hypertension (see section
Slovenian: Idiopatska pljučna fibroza (IPF) s sekundarno pljučno hipertenzijo ali brez nje (glejte poglavje 5.1).
English: This slight increase in sildenafil Cmax is not considered clinically relevant (see section
Slovenian: To rahlo povečanje vrednosti Cmax sildenafila ni klinično pomembno (glejte poglavje 4.5).
English: Palpitation
Slovenian: Palpitacije
English: Ambrisentan was clastogenic when tested at high concentrations in mammalian cells in vitro.
Slovenian: Ambrisentan je in vitro, na sesalskih celicah, v visokih koncentracijah deloval klastogeno.
English: Respiratory, thoracic and mediastinal disorders Epistaxis
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Epistaksa
English: Contains lactose, lecithin (soya) (E322) and Allura red AC Aluminium Lake (E129).
Slovenian: Vsebuje laktozo, lecitin (soja) (E322) in alurno rdeče AC (E129).
English: How to take Volibris
Slovenian: Kako jemati zdravilo Volibris
English: Each film-coated tablet contains 5 or 10 mg.
Slovenian: Ena filmsko obložena tableta vsebuje 5 ali 10 mg ambrisentana.
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: 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).
English: See leaflet for further information
Slovenian: Za dodatne informacije glejte priloženo navodilo.
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: poročali o neželenih učinkih na vedenje mater, zmanjšanem preživetju mladičev in manjši sposobnosti za razmnoževanje mladičev (pri nekropsiji so poročali o majhnih testisih).
English: 8 Cases of autoimmune hepatitis, including cases of exacerbation of autoimmune hepatitis, and hepatic injury have been reported during ambrisentan therapy.
Slovenian: 8 Med zdravljenjem z ambrisentanom so bili opisani primeri avtoimunskega hepatitisa, vključno s primeri poslabšanja avtoimunskega hepatitisa, in okvara jeter.
English: Aspen Bad Oldesloe GmbH Industriestrasse 32-36 D-23843 Bad Oldesloe Germany or
Slovenian: Industriestrasse 32-36 D-23843 Bad Oldesloe
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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 <
English: Hepatic transaminases increased Common3
Slovenian: Zvišanje jetrnih transaminaz
English: Across the 12 week placebo controlled Phase 3 clinical studies, mean haemoglobin concentrations decreased for patients in the ambrisentan groups and were detected as early as week 4 (decrease by 0.83 g/dL); mean changes from baseline appeared to stabilise over the subsequent 8 weeks.
Slovenian: 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).
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: UGT1A6, UGT1A9, UGT2B7 (do 30 %) ali encimov citokroma P450 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 in 3A4 (do 25 %).
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: 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.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Volibris Vsebina pakiranja in dodatne informacije
English: 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).
Slovenian: 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).
English: Pale-pink, square, convex, film-coated tablet with “GS” debossed on one side and “K2C” on the other side.
Slovenian: Svetlorožnate, kvadratne, konveksne filmsko obložene tablete z oznako "GS" na eni in "K2C" na drugi strani.
English: Combination with tadalafil
Slovenian: Kombinacija s tadalafilom
English: Ambrisentan does not inhibit or induce phase I or II drug metabolising enzymes at clinically relevant concentrations in in vitro and in vivo non-clinical studies, suggesting a low potential for ambrisentan to alter the profile of medicinal products metabolised by these pathways.
Slovenian: 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.
English: → If it is possible you could become pregnant, use a reliable form of birth control (contraception) while you're taking Volibris.
Slovenian: → Če obstaja možnost zanositve, morate med zdravljenjem z zdravilom Volibris uporabljati zanesljivo obliko kontracepcije.
English: Multiple doses of ambrisentan had no effect on cyclosporine A exposure, and no dose adjustment of cyclosporine A is warranted.
Slovenian: Večkratni odmerki ambrisentana ne vplivajo na izpostavljenost ciklosporinu A,zato odmerka ciklosporina A ni treba prilagoditi.
English: No evidence for mutagenic or genotoxic effects of ambrisentan were seen in bacteria or in two in vivo rodent studies.
Slovenian: Pri bakterijah in v dveh in vivo študijah na glodavcih mutagenega in genotoksičnega delovanja ambrisentana niso ugotovili.
English: • Obligation to conduct post-authorisation measures
Slovenian: • Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet Navedba smiselno ni potrebna.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/451/003 10 film-coated tablets
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/08/451/003 10 filmsko obloženih tablet
English: If patients develop sustained, unexplained, clinically significant ALT and/or AST elevation, or if ALT and/or AST elevation is accompanied by signs or symptoms of hepatic injury (e.g. jaundice), ambrisentan therapy should be discontinued.
Slovenian: ALT ali AST ali obeh, ali zvišanje vrednosti ALT ali AST ali obeh spremljajo znaki in simptomi okvare jeter (npr. zlatenica), je treba zdravljenje z ambrisentanom prekiniti.
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
English: The main routes of metabolism of ambrisentan are glucuronidation and oxidation with subsequent elimination in the bile and therefore hepatic impairment might be expected to increase exposure (Cmax and AUC) of ambrisentan.
Slovenian: Okvara jeter 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.
English: Volibris 5 mg film-coated tablets Each tablet contains 5 mg of ambrisentan.
Slovenian: Volibris 5 mg filmsko obložene tablete 1 tableta vsebuje 5 mg ambrisentana.
English: Volibris 10 mg film-coated tablets Each tablet contains 10 mg of ambrisentan.
Slovenian: Volibris 10 mg filmsko obložene tablete 1 tableta vsebuje 10 mg ambrisentana.
English: Blood and lymphatic system disorders Anaemia (decreased haemoglobin, decreased haematocrit)
Slovenian: Anemija (znižana vrednost hemoglobina, znižana vrednost hematokrita)
English: Talk to your doctor if you have any questions or concerns about this.
Slovenian: Če imate o tem kakršnokoli vprašanje ali ste zaskrbljeni, se posvetujte s svojim zdravnikom.
English: Always take this medicine exactly as your doctor or pharmacist has told you to.
Slovenian: Pri jemanju tega zdravila natančno upoštevajte navodila svojega zdravnika ali farmacevta.
English: Disease progression
Slovenian: Očesne bolezni
English: The effects of repeat dosing of cyclosporine A (100 - 150 mg twice daily) on the steady-state pharmacokinetics of ambrisentan (5 mg once daily), and the effects of repeat dosing of ambrisentan (5 mg once daily) on the steady-state pharmacokinetics of cyclosporine A (100 - 150 mg twice daily)
Slovenian: Učinke ponavljajočih se odmerkov ciklosporina A (100-150 mg dvakrat na dan) na farmakokinetiko ambrisentana (5 mg enkrat na dan) v stanju dinamičnega ravnovesja in učinke ponavljajočih se odmerkov ambrisentana (5 mg enkrat na dan) na farmakokinetiko ciklosporina A (100-150 mg dvakrat na dan) v stanju dinamičnega ravnovesja so raziskali pri zdravih prostovoljcih.
English: What you need to know before you take Volibris
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Volibris Ne jemljite zdravila Volibris
English: Hypotension (low blood pressure) This can cause light-headedness.
Slovenian: Hipotenzija (nizek krvni tlak)
English: Ambrisentan and its metabolites are eliminated primarily in the bile following hepatic and/or extrahepatic metabolism.
Slovenian: Izločanje Ambrisentan in njegovi presnovki se po jetrni in/ali izven jetrni presnovi v glavnem izločijo z žolčem.
English: • a runny or blocked nose, congestion or pain in the sinuses
Slovenian: • poslabšanje težkega dihanja kmalu po začetku uporabe zdravila Volibris, • izcedek iz nosu ali zmašen nos, kongestija ali bolečine v obnosnih votlinah (sinusih),
English: - If you get any side effects talk to your doctor, pharmacist or nurse.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro.
English: Gastrointestinal disorders Nausea, vomiting, diarrhoea
Slovenian: Bolezni prebavil Navzea, bruhanje, driska
English: The placebo-adjusted improvement in mean 6MWD at week 12 compared to baseline was 30.6 m (95% CI: 2.9 to 58.3; p=0.008) and 59.4 m (95% CI: 29.6 to 89.3; p<0.001) for the 5 mg group, in
Slovenian: V skupini, ki je prejemala 5 mg odmerek, je v študiji ARIES-1 na placebo prilagojeno izboljšanje povprečnega rezultata 6MWD v 12. tednu v primerjavi z izhodiščem znašalo 30,6 m (95 % interval zaupanja: 2,9 do 58,3; p = 0,008), v študiji ARIES-2 pa 59,4 m (95 % interval zaupanja: 29,6 do 89,3; p < 0,001).
English: Breast-feeding It is not known if Volibris is transferred to breast milk.
Slovenian: Ni znano, če se zdravilo Volibris izloča v materino mleko.
English: Volibris contains the active substance ambrisentan.
Slovenian: Zdravilo Volibris vsebuje zdravilno učinkovino ambrisentan.
English: Autoimmune hepatitis (see section
Slovenian: Avtoimunski hepatitis (glejte poglavje 4.4)
English: NAME OF THE MARKETING AUTHORISATION HOLDER GlaxoSmithKline (Ireland) Limited
Slovenian: IMETNIK DOVOLJENJA ZA PROMET GlaxoSmithKline (Ireland) Limited
English: →Tell your doctor straight away if you get these effects or if they happen suddenly after taking Volibris.
Slovenian: →Če se vam pojavijo ti učinki ali nastanejo nenadoma po jemanju zdravila Volibris, to takoj povejte svojemu zdravniku.
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: 0,348 do 0,724, p = 0,0002) sestavljenega opazovanega dogodka kliničnega neuspeha [slika 1 in preglednica 1].
English: How to store Volibris
Slovenian: Shranjevanje zdravila Volibris
English: Lecithin (soya) (E322) Allura red AC Aluminium Lake (E129)
Slovenian: lecitin (soja) (E322) in rdeče AC (E129).
English: Name and address of the manufacturer responsible for batch release
Slovenian: IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca, odgovornega za sproščanje serij
English: 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).
Slovenian: Pri zdravih prostovoljcih pri uporabi ambrisentana v stanju dinamičnega ravnovesja niso opazili klinično pomembnih učinkov na farmakokinetiko enkratnega odmerka digoksina, substrata za Pgp
English: Reductions in haemoglobin concentrations and haematocrit have been associated with endothelin receptor antagonists (ERAs) including ambrisentan.
Slovenian: Koncentracija hemoglobina V povezavi z antagonisti endotelinskih receptorjev (ERA - endothelin receptor antagonists), vključno z ambrisentanom, so poročali o znižanju koncentracije hemoglobina in hematokrita .
English: Volibris 5 mg film-coated tablets Volibris 10 mg film-coated tablets
Slovenian: Volibris 5 mg filmsko obložene tablete Volibris 10 mg filmsko obložene tablete
English: Furthermore, ambrisentan did not induce MRP2, Pgp or BSEP protein expression in rat hepatocytes.
Slovenian: Poleg tega ambrisentan v podganjih jetrnih celicah ni induciral ekspresije beljakovin MRP2, Pgp ali
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: P-glikoproteinom (Pgp), proteinom odpornosti na rak dojke (BRCP), proteinom 2 za odpornost na več zdravil (MRP2), iztočno črpalko žolčnih soli (BSEP), transportnim polipeptidom organskih anionov
English: The effects of 12 days dosing with ambrisentan (10 mg once daily) on the pharmacokinetics of a single dose of oral contraceptive containing ethinyl estradiol (35 μg) and norethindrone (1 mg) were studied in healthy female volunteers.
Slovenian: Pri zdravih prostovoljkah so raziskali učinke 12-dnevne uporabe ambrisentana (10 mg enkrat na dan) na farmakokinetiko enkratnega odmerka peroralnega kontraceptiva z etinilestradiolom (35 μg) in noretindronom (1 mg).
English: Marketing Authorisation Holder GlaxoSmithKline (Ireland) Limited 12 Riverwalk
Slovenian: Imetnik dovoljenja za promet z zdravilom GlaxoSmithKline (Ireland) Limited 12 Riverwalk
English: 4 Data derived from routine pharmacovigilance surveillance 5 Most of the reported cases of cardiac failure were associated with fluid retention.
Slovenian: 5 Večina opisanih primerov srčnega popuščanja je bila povezana z zastajanjem tekočine.
English: GlaxoSmithKline (Cyprus) Ltd Τηλ: + 357 22 39 70 00 gskcyprus@gsk.com
Slovenian: GlaxoSmithKline (Cyprus) Ltd Τηλ: + 357 22 39 70 00
English: Contents of the pack and other information What Volibris contains The active substance is ambrisentan.
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Volibris
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu, kjer lahko najdete tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
English: Treatment with ambrisentan resulted in an increase in mean cardiac index, a decrease in mean pulmonary artery pressure, and a decrease in mean pulmonary vascular resistance.
Slovenian: zmanjšal srednji pljučni arterijski krvni tlak in zmanjšal srednji pljučni žilni upor.
English: Ambrisentan had no effects on the steady-state pharmacokinetics and anti-coagulant activity of warfarin in a healthy volunteer study (see section 5.2).
Slovenian: V študiji pri zdravih prostovoljcih ambrisentan ni vplival na farmakokinetiko v stanju dinamičnega ravnovesja in antikoagulatno delovanje varfarina (glejte poglavje 5.2).
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: 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”)
English: Volibris 10 mg film-coated tablets
Slovenian: Volibris 10 mg filmsko obložene tablete
English: NAME OF THE MEDICINAL PRODUCT Volibris 10 mg tablets ambrisentan
Slovenian: IME ZDRAVILA Volibris 10 mg tablete ambrisentan
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blisters
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
English: NAME OF THE MEDICINAL PRODUCT Volibris 5 mg tablets ambrisentan
Slovenian: IME ZDRAVILA Volibris 5 mg tablete ambrisentan
English: Volibris 5 mg film-coated tablets EU/1/08/451/001
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Volibris 5 mg filmsko obložene tablete EU/1/08/451/001
English: General disorders and administration site conditions Peripheral oedema, fluid retention Very common
Slovenian: Periferni edemi, zastajanje tekočine Zelo pogosti
English: Therefore the dose of ambrisentan should be limited to 5 mg once daily when co-administered with cyclosporine A (see section 4.2).
Slovenian: Glede na ti spremembi je treba odmerek ambrisentana med sočasno uporabo s ciklosporinom A omejiti na 5 mg enkrat na dan (glejte poglavje 4.2).
English: Volibris contains lactose, lecithin (soya), Allura red AC Aluminium Lake (E129) and sodium Volibris tablets contain small amounts of a sugar called lactose.
Slovenian: Zdravilo Volibris vsebuje laktozo, (sojin) lecitin, barvilo alurno rdeče AC (E129) in natrij
English: Volibris is indicated for treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment (see section 5.1).
Slovenian: do III. funkcijskem razredu po Svetovni zdravstveni organizaciji (SZO), vključno z uporabo v kombinaciji (glejte poglavje 5.1).
English: The effects of steady-state ambrisentan (10 mg once daily) on the pharmacokinetics and pharmacodynamics of a single dose of warfarin (25 mg), as measured by PT and INR, were investigated in 20 healthy volunteers.
Slovenian: Učinek ambrisentana v stanju dinamičnega ravnovesja (10 mg enkrat na dan) na farmakokinetiko in farmakodinamiko enkratnega odmerka varfarina (25 mg), vrednoteno s PT in INR, so raziskovali pri
English: Volibris 5 mg film-coated tablets
Slovenian: Volibris 5 mg filmsko obložene tablete
English: Titanium dioxide (E171) Macrogol 3350
Slovenian: Filmska obloga polivinilalkohol (delno hidrolizirani) smukec (E553b) titanov dioksid (E171) makrogol 3350 lecitin (soja) (E322)
English: Don't stop taking Volibris without your doctor's advice Volibris is a treatment that you will need to keep on taking to control your PAH.
Slovenian: →Ne prenehajte z jemanjem zdravila Volibris brez nasveta zdravnika.
English: Pregnancy Volibris may harm unborn babies conceived before, during or soon after treatment.
Slovenian: Če zanosite pred, med ali kmalu po koncu zdravljenja, lahko zdravilo Volibris škoduje nerojenemu otroku.
English: Package leaflet: Information for the user Volibris 5 mg film-coated tablets Volibris 10 mg film-coated tablets ambrisentan
Slovenian: NAVODILO ZA UPORABO Volibris 5 mg filmsko obložene tablete Volibris 10 mg filmsko obložene tablete ambrisentan
English: NR - not reported
Slovenian: Ni znano4
English: 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).
Slovenian: 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.
English: • being sick (vomiting)
Slovenian: • siljenje na bruhanje (navzeo),
English: The incidence of anaemia was increased when ambrisentan was dosed in combination with tadalafil (15%
Slovenian: Pojavnost anemije je bila med uporabo ambrisentana v kombinaciji s tadalafilom večja (15 %) kot med monoterapijo z ambrisentanom (7 %) ali monoterapijo s tadalafilom (11 %).
English: Eye disorders Blurred vision, visual impairment Not known4
Slovenian: Zamegljen vid, okvara vida
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali medicinsko sestro.
English: Each tablet contains approximately 90 mg of lactose (as monohydrate), approximately 0.25 mg of lecithin (soya) (E322) and approximately 0.45 mg of Allura red AC Aluminium Lake (E129).
Slovenian: Volibris 10 mg filmsko obložene tablete Ena tableta vsebuje približno 90 mg laktoze (v obliki monohidrata), približno 0,25 mg lecitina (soja)
English: Nasal bone hyperplasia of the ethmoid turbinates has been observed in the nasal cavity of rats treated with ambrisentan, at exposure levels 3-fold the clinical AUC.
Slovenian: Pri podganah, ki so prejemale ambrisentan, so pri izpostavljenosti, ki je ustrezala 3-kratni vrednosti
English: Asthenia
Slovenian: bolnikov.
English: Monotherapy pooled
Slovenian: Monoterapija kumulativno